189 results on '"Salwender, Hans"'
Search Results
2. Elotuzumab, lenalidomide, bortezomib, dexamethasone, and autologous haematopoietic stem-cell transplantation for newly diagnosed multiple myeloma (GMMG-HD6): results from a randomised, phase 3 trial
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Mai, Elias K, Goldschmidt, Hartmut, Miah, Kaya, Bertsch, Uta, Besemer, Britta, Hänel, Mathias, Krzykalla, Julia, Fenk, Roland, Schlenzka, Jana, Munder, Markus, Dürig, Jan, Blau, Igor W, Huhn, Stefanie, Hose, Dirk, Jauch, Anna, Kunz, Christina, Mann, Christoph, Weinhold, Niels, Scheid, Christof, Schroers, Roland, von Metzler, Ivana, Schieferdecker, Aneta, Thomalla, Jörg, Reimer, Peter, Mahlberg, Rolf, Graeven, Ullrich, Kremers, Stephan, Martens, Uwe M, Kunz, Christian, Hensel, Manfred, Benner, Axel, Seidel-Glätzer, Andrea, Weisel, Katja C, Raab, Marc S, Salwender, Hans J, Adrian, Nicole, Bernhard, Helga, Böck, Hans-Peter, Bolling, Claus, Dingeldein, Gerrit, Emde, Till-Oliver, Ferstl, Barbara, Fietz, Thomas, Fronhoffs, Stefan, Fuhrmann, Stephan, Fuxius, Stefan, Geer, Thomas, Görner, Martin, Guenther, Barbara, Hartmann, Frank, Heilmeier, Bernhard, Heinsch, Michael, Hoffmann, Martin, Holderried, Tobias A.W., Klein, Stefan, Klump, Martin, Knauf, Wolfgang, La Rosée, Paul, Lange, Elisabeth, Lindemann, Walter, Lopez, Roderico, Mayer, Frank, Nückel, Holger, Papesch, Eva, Procaccianti, Maria, Reichart, Alexander, Rummel, Mathias, Scheuer, Lars, Schmitt, Hans-Roland, Staib, Peter, Steiniger, Heike, Tischler, Hans-Joachim, Ulshöfer, Thomas, Verbeek, Walter, Wacker, Alexander, and Zirpel, Iris
- Abstract
The aim of this trial was to investigate the addition of the anti-SLAMF7 monoclonal antibody elotuzumab to lenalidomide, bortezomib, and dexamethasone (RVd) in induction and consolidation therapy as well as to lenalidomide maintenance treatment in transplant-eligible patients with newly diagnosed multiple myeloma.
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- 2024
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3. Treatment pattern and outcomes of re-induction therapy prior to stem cell transplantation in patients with relapsed/refractory multiple myeloma in Germany
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Sauer, Sandra, Engelhardt, Monika, Trautmann-Grill, Karolin, Kimmich, Christoph, Hänel, Mathias, Schmidt-Hieber, Martin, Salwender, Hans, Flossmann, Carmen, Heckmann, Hiltrud, Ertel, Franziska, Friederich, Andrea, Patel, Sachin, Thun, Barbara, and Raab, Marc S.
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There are limited data guiding choice of re-induction therapies for patients with relapsed/refractory multiple myeloma (RRMM) prior to stem cell transplantation (SCT). We performed a retrospective medical chart review of 171 patients with RRMM in Germany who received re-induction therapy in second line (78%; n= 134) or third line (22%; n= 37) prior to re-SCT. Index therapy was defined as first completed re-induction therapy for planned myeloablative conditioning and SCT in second/third line within the eligibility period (1/2016–12/2019). Most common pre-index first line and maintenance therapy used were bortezomib-based combinations (91%; n= 155/171) and lenalidomide (55%; n= 29/53), respectively. Median duration of index therapy line was 9 months; carfilzomib-based combinations were the most widely used in second/third line re-induction therapy (49%; n= 83/171), followed by daratumumab-based combinations (21%; n= 36/171). Overall response rates in second/third line were 87% after re-induction and 96% after SCT; median time to next treatment line after start of index therapy was 31 months; median progression-free survival (PFS) was 29 months; and median overall survival after index date was not reached. Based on these data, re-induction therapy with salvage SCT appears to be beneficial in selected patients with RRMM in clinical practice in Germany, translating into deep responses, long PFS and prolonged time to next treatment.
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- 2024
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4. Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone as induction therapy for newly diagnosed, transplantation-eligible patients with multiple myeloma (GMMG-HD7): part 1 of an open-label, multicentre, randomised, active-controlled, phase 3 trial
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Goldschmidt, Hartmut, Mai, Elias K, Bertsch, Uta, Fenk, Roland, Nievergall, Eva, Tichy, Diana, Besemer, Britta, Dürig, Jan, Schroers, Roland, von Metzler, Ivana, Hänel, Mathias, Mann, Christoph, Asemissen, Anne M, Heilmeier, Bernhard, Weinhold, Niels, Huhn, Stefanie, Kriegsmann, Katharina, Luntz, Steffen P, Holderried, Tobias A W, Trautmann-Grill, Karolin, Gezer, Deniz, Klaiber-Hakimi, Maika, Müller, Martin, Khandanpour, Cyrus, Knauf, Wolfgang, Scheid, Christof, Munder, Markus, Geer, Thomas, Riesenberg, Hendrik, Thomalla, Jörg, Hoffmann, Martin, Raab, Marc S, Salwender, Hans J, Weisel, Katja C, Asemissen, Anne M, Behringer, Joachim, Bernhard, Helga, Bernhardt, Christiane, Bertsch, Uta, Besemer, Britta, Blau, Igor W, Bolling, Claus, Debatin, Daniel, Dingeldein, Gerrit, Dürig, Jan, Fenk, Roland, Ferstl, Barbara, Fest, Claudia, Fronhoffs, Stefan, Fuhrmann, Stephan, Gaska, Tobias, Geer, Thomas, Gezer, Deniz, Goldschmidt, Hartmut, Görner, Martin, Graeven, Ullrich, Grassinger, Jochen, Hänel, Mathias, Heilmeier, Bernhard, Heinsch, Michael, Held, Gerhard, Hoffmann, Martin, Holderried, Tobias A W, Hopfer, Olaf, Huhn, Stefanie, Immenschuh, Peter, Kaddu-Mulindwa, Dominic, Khandanpour, Cyrus, Klaiber-Hakimi, Maika, Klausmann, Martine, Klein, Stefan, Knauf, Wolfgang, Ko, Yon-Dschun, Köchling, Georg, Koenigsmann, Michael, Kostrewa, Philippe, Kraemer, Doris Maria, Kremers, Stephan, Kriegsmann, Katharina, Kropff, Martin, La Rosée, Paul, Luntz, Steffen P, Mahlberg, Rolf, Mai, Elias K, Mann, Christoph, Martens, Uwe, von Metzler, Ivana, Müller, Martin, Munder, Markus, Neise, Michael, Nievergall, Eva, Nückel, Holger, Pönisch, Wolfram, Procaccianti, Maria, Raab, Marc S, Rafiyan, Mohammed R, Reimer, Peter, Riecke, Armin, Riesenberg, Hendrik, Rummel, Mathias, Runde, Volker, Salwender, Hans J, Schaich, Markus, Scheid, Christoph, Schmidt-Hieber, Martin, Schmitt, Stefan, Schöndube, Daniel, Schroers, Roland, Schwarzer, Andreas, Staib, Peter, Steiniger, Heike, Sturmberg, Dirk, Thomalla, Jörg, Tichy, Diana, Tischler, Hans-Joachim, Trautmann-Grill, Karolin, Trummer, Arne, Tschechne, Barbara, Verbeek, Walter, Weinhold, Niels, Weisel, Katja C, Whitlock, Bettina, de Wit, Maike, Zaiß, Matthias, and Ziske, Carsten
- Abstract
Anti-CD38 monoclonal antibodies have consistently shown increased efficacy when added to standard of care for patients with multiple myeloma. We aimed to assess the efficacy of isatuximab in addition to lenalidomide, bortezomib, and dexamethasone in patients with newly diagnosed transplantation-eligible multiple myeloma.
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- 2022
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5. Comparison of bone marrow and peripheral blood aberrant plasma cell assessment by NGF in patients with MM
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Kriegsmann, Katharina, Manta, Calin, Schwab, Ricarda, Mai, Elias K., Raab, Marc S., Salwender, Hans J., Fenk, Roland, Besemer, Britta, Dürig, Jan, Schroers, Roland, von Metzler, Ivana, Hänel, Mathias, Mann, Christoph, Asemissen, Anne M., Heilmeier, Bernhard, Bertsch, Uta, Huhn, Stefanie, Müller-Tidow, Carsten, Goldschmidt, Hartmut, and Hundemer, Michael
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- 2023
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6. Predictors of early morbidity and mortality in newly diagnosed multiple myeloma: data from five randomized, controlled, phase III trials in 3700 patients
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Mai, Elias K., Hielscher, Thomas, Bertsch, Uta, Salwender, Hans J., Zweegman, Sonja, Raab, Marc S., Munder, Markus, Pantani, Lucia, Mancuso, Katia, Brossart, Peter, Beksac, Meral, Blau, Igor W., Dürig, Jan, Besemer, Britta, Fenk, Roland, Reimer, Peter, van der Holt, Bronno, Hänel, Mathias, von Metzler, Ivana, Graeven, Ullrich, Müller-Tidow, Carsten, Boccadoro, Mario, Scheid, Christof, Dimopoulos, Meletios A., Hillengass, Jens, Weisel, Katja C., Cavo, Michele, Sonneveld, Pieter, and Goldschmidt, Hartmut
- Abstract
Early morbidity and mortality affect patient outcomes in multiple myeloma. Thus, we dissected the incidence and causes of morbidity/mortality during induction therapy (IT) for newly diagnosed multiple myeloma (NDMM), and developed/validated a predictive risk score. We evaluated 3700 transplant-eligible NDMM patients treated in 2005–2020 with novel agent-based triplet/quadruplet IT. Primary endpoints were severe infections, death, or a combination of both. Patients were divided in a training (n= 1333) and three validation cohorts (n= 2367). During IT, 11.8%, 1.8%, and 12.5% of patients in the training cohort experienced severe infections, death, or both, respectively. Four major, baseline risk factors for severe infection/death were identified: low platelet count (<150/nL), ISS III, higher WHO performance status (>1), and age (>60 years). A risk score (1 risk factor=1 point) stratified patients in low (39.5%; 0 points), intermediate (41.9%; 1 point), and high (18.6%; ≥2 points) risk. The risk for severe infection/death increased from 7.7% vs. 11.5% vs. 23.3% in the low- vs. intermediate- vs. high-risk groups (p< 0.001). The risk score was independently validated in three trials incorporating quadruplet IT with an anti-CD38 antibody. Our analyses established a robust and easy-to-use score to identify NDMM patients at risk of severe infection/death, covering the latest quadruplet induction therapies. Trial registrations: HOVON-65/GMMG-HD4: EudraCT No. 2004-000944-26. GMMG-MM5: EudraCT No. 2010-019173-16. GMMG-HD6: NCT02495922. EMN02/HOVON-95: NCT01208766. GMMG-HD7: NCT03617731.
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- 2023
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7. Midostaurin plus intensive chemotherapy for younger and older patients with AML and FLT3 internal tandem duplications
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Döhner, Hartmut, Weber, Daniela, Krzykalla, Julia, Fiedler, Walter, Wulf, Gerald, Salih, Helmut, Lübbert, Michael, Kühn, Michael W. M., Schroeder, Thomas, Salwender, Hans, Götze, Katharina, Westermann, Jörg, Fransecky, Lars, Mayer, Karin, Hertenstein, Bernd, Ringhoffer, Mark, Tischler, Hans-Joachim, Machherndl-Spandl, Sigrid, Schrade, Anika, Paschka, Peter, Gaidzik, Verena I., Theis, Frauke, Thol, Felicitas, Heuser, Michael, Schlenk, Richard F., Bullinger, Lars, Saadati, Maral, Benner, Axel, Larson, Richard, Stone, Richard, Döhner, Konstanze, and Ganser, Arnold
- Abstract
We conducted a single-arm, phase 2 trial (German-Austrian Acute Myeloid Leukemia Study Group [AMLSG] 16-10) to evaluate midostaurin with intensive chemotherapy followed by allogeneic hematopoietic-cell transplantation (HCT) and a 1-year midosta urin maintenance therapy in adult patients with acute myeloid leukemia (AML) and fms-related tyrosine kinase 3 (FLT3) internal tandem duplication (ITD). Patients 18 to 70 years of age with newly diagnosed FLT3-ITD-positive AML were eligible. Primary and key secondary endpoints were event-free survival (EFS) and overall survival (OS). Results were compared with a historical cohort of 415 patients treated on 5 prior AMLSG trials; statistical analysis was performed using a double-robust adjustment with propensity score weighting and covariate adjustment. Results were also compared with patients (18-59 years) treated on the placebo arm of the Cancer and Leukemia Group B (CALGB) 10603/RATIFY trial. The trial accrued 440 patients (18-60 years, n = 312; 61-70 years, n = 128). In multivariate analysis, EFS was significantly in favor of patients treated within the AMLSG 16-10 trial compared with the AMLSG control (hazard ratio [HR], 0.55; P < .001); both in younger (HR, 0.59; P < .001) and older patients (HR, 0.42; P < .001). Multivariate analysis also showed a significant beneficial effect on OS compared with the AMLSG control (HR, 0.57; P < .001) as well as to the CALGB 10603/RATIFY trial (HR, 0.71; P = .005). The treatment effect of midostaurin remained significant in sensitivity analysis including allogeneic HCT as a time-dependent covariate. Addition of midostaurin to chemotherapy was safe in younger and older patients. In comparison with historical controls, the addition of midostaurin to intensive therapy led to a significant improvement in outcome in younger and older patients with AML and FLT3-ITD. This trial is registered at clinicaltrialsregistry.eu as Eudra-CT number 2011-003168-63 and at clinicaltrials.gov as NCT01477606.
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- 2022
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8. Isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) in front-line treatment of high-risk multiple myeloma: interim analysis of the GMMG-CONCEPT trial
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Leypoldt, Lisa B., Besemer, Britta, Asemissen, Anne Marie, Hänel, Mathias, Blau, Igor Wolfgang, Görner, Martin, Ko, Yon-Dschun, Reinhardt, Hans Christian, Staib, Peter, Mann, Christoph, Lutz, Raphael, Munder, Markus, Graeven, Ullrich, Peceny, Rudolf, Salwender, Hans, Jauch, Anna, Zago, Manola, Benner, Axel, Tichy, Diana, Bokemeyer, Carsten, Goldschmidt, Hartmut, and Weisel, Katja C.
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- 2022
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9. MCT1 is a predictive marker for lenalidomide maintenance therapy in multiple myeloma
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Stroh, Jacob, Seckinger, Anja, Heider, Michael, Rudelius, Martina, Eichner, Ruth, Schick, Markus, Slawska, Jolanta, Emde-Rajaratnam, Martina, Salwender, Hans, Bertsch, Uta, Goldschmidt, Hartmut, Weisel, Katja, Scheid, Christof, Keller, Ulrich, Hose, Dirk, and Bassermann, Florian
- Abstract
Biomarkers that predict response to lenalidomide maintenance therapy in patients with multiple myeloma (MM) have remained elusive. We have shown that immunomodulatory drugs (IMiDs) exert anti-MM activity via destabilization of MCT1 and CD147. In this study, cell samples of 654 patients with MM who received lenalidomide (n = 455), thalidomide (n = 98), or bortezomib (n = 101) maintenance were assessed by gene expression profiling and RNA sequencing, followed by correlation of MCT1 and CD147 expression with data for progression-free survival (PFS) and overall survival (OS). Patients with high expression levels of MCT1 showed significantly reduced PFS (31.9 months vs 48.2 months in MCT1high vs MCT1low; P = .03) and OS (75.9 months vs not reached [NR] in MCT1high vs MCT1low; P = .001) in cases with lenalidomide maintenance, whereas MCT1 expression had no significant impact on PFS or OS in cases with bortezomib maintenance. We validated the predictive role of MCT1 for IMiD-based maintenance in an independent cohort of patients who received thalidomide (OS, 83.6 months vs NR in MCT1high vs MCT1low; P = .03). Functional validation showed that MCT1 overexpression in human MM cell lines significantly reduced the efficacy of lenalidomide, whereas no change was observed with bortezomib treatment, either in vitro or in a MM xenograft model. Our findings have established MCT1 expression as a predictive marker for response to lenalidomide-based maintenance in patients with MM.
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- 2022
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10. Catheter-related infection and thrombosis of the internal jugular vein in hematologic-oncologic patients undergoing chemotherapy: a prospective comparison of silver-coated and uncoated catheters
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Harter, Christoph, Salwender, Hans Jurgen, Bach, Alfons, Egerer, Gerlinde, Goldschmidt, Hartmut, and Ho, Anthony D.
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Intravenous catheterization -- Complications ,Catheters -- Evaluation ,Thrombophlebitis -- Prevention ,Health - Published
- 2002
11. Implications and Prognostic Impact of Mass Spectrometry in Patients with Newly-Diagnosed Multiple Myeloma
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Mai, Elias K, Huhn, Stefanie, Miah, Kaya, Poos, Alexandra M, Scheid, Christof, Weisel, Katja, Bertsch, Uta, Munder, Markus, Berlanga, Oscar, Hose, Dirk, Seckinger, Anja, Jauch, Anna, Blau, Igor Wolfgang, Haenel, Mathias, Salwender, Hans, Benner, Axel, Raab, Marc S, Goldschmidt, Hartmut, and Weinhold, Niels
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- 2022
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12. Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (Isa-KRd) in Patients with High-Risk Newly Diagnosed Multiple Myeloma: Planned Interim Analysis of the GMMG-Concept Trial
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Weisel, Katja, Besemer, Britta, Haenel, Mathias, Lutz, Raphael, Mann, Christoph, Munder, Markus, Goerner, Martin, Reinhardt, Hans Christian, Nogai, Axel, Ko, Yon-Dschun, De Wit, Maike, Salwender, Hans, Scheid, Christoph, Graeven, Ullrich, Peceny, Rudolf, Staib, Peter, Dieing, Annette, Jauch, Anna, Zago, Manola, Benner, Axel, Tichy, Diana, Bokemeyer, Carsten, Goldschmidt, Hartmut, and Leypoldt, Lisa B.
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- 2022
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13. Bone Marrow Immune Signatures in Multiple Myeloma Are Linked to Tumor Heterogeneity and Treatment Outcome
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Steiger, Simon, Lutz, Raphael, Prokoph, Nina, Palit, Subarna, Tirier, Stephan M, Reichert, Philipp, Baumann, Anja, Hefner, Nadine, Schumacher, Sabrina, Vonficht, Dominik, Grünschläger, Florian, Poos, Alexandra M, John, Lukas, Haghverdi, Laleh, Mallm, Jan-Philipp, Mai, Elias K, Friedrich, Mirco, Kriegsmann, Katharina, Awwad, Mohamed H.S., Jauch, Anna, Bertsch, Uta, Tichy, Diana, Müller-Tidow, Carsten, Schroers, Roland, Salwender, Hans, Besemer, Britta, Fenk, Roland, Weisel, Katja, Goldschmidt, Hartmut, Huhn, Stefanie, Hundemer, Michael, Rippe, Karsten, Haas, Simon, Weinhold, Niels, and Raab, Marc S
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- 2022
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14. Long-term follow-up of subcutaneous versus intravenous bortezomib during induction therapy for newly diagnosed multiple myeloma treated within the GMMG-MM5 Phase III Trial
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Salwender, Hans, Elmaagacli, Ahmet, Merz, Maximilian, Miah, Kaya, Benner, Axel, Haenel, Mathias, Jehn, Christian, Mai, Elias K., Bertsch, Uta, Blau, Igor W., Scheid, Christof, Hose, Dirk, Seckinger, Anja, Jauch, Anna, Raab, Marc S., Luntz, Steffen P., Besemer, Britta, Munder, Markus, Brossart, Peter, Fuhrmann, Stephan, Lindemann, Hans-Walter, Weisel, Katja, Duerig, Jan, and Goldschmidt, Hartmut
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- 2021
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15. Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE
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Goldschmidt, Hartmut, Baertsch, Marc-Andrea, Schlenzka, Jana, Becker, Natalia, Habermehl, Christina, Hielscher, Thomas, Raab, Marc-Steffen, Hillengass, Jens, Sauer, Sandra, Müller-Tidow, Carsten, Luntz, Steffen, Jauch, Anna, Hose, Dirk, Seckinger, Anja, Brossart, Peter, Goerner, Martin, Klein, Stefan, Schmidt-Hieber, Martin, Reimer, Peter, Graeven, Ullrich, Fenk, Roland, Haenel, Mathias, Martin, Hans, Lindemann, Hans W., Scheid, Christoph, Nogai, Axel, Salwender, Hans, Noppeney, Richard, Besemer, Britta, and Weisel, Katja
- Abstract
The role of salvage high-dose chemotherapy and autologous stem cell transplantation (sHDCT/ASCT) for relapsed and/or refractory multiple myeloma (RRMM) in the era of continuous novel agent treatment has not been defined. This randomized, open-label, phase III, multicenter trial randomized patients with 1st–3rd relapse of multiple myeloma (MM) to a transplant arm (n= 139) consisting of 3 Rd (lenalidomide 25 mg, day 1–21; dexamethasone 40 mg, day 1, 8, 15, and 22; 4-week cycles) reinduction cycles, sHDCT (melphalan 200 mg/m2), ASCT, and lenalidomide maintenance (10 mg/day) or to a control arm (n= 138) of continuous Rd. Median PFS was 20.7 months in the transplant and 18.8 months in the control arm (HR 0.87; 95% CI 0.65–1.16; p= 0.34). Median OS was not reached in the transplant and 62.7 months in the control arm (HR 0.81; 95% CI 0.52–1.28; p= 0.37). Forty-one patients (29%) did not receive the assigned sHDCT/ASCT mainly due to early disease progression, adverse events, and withdrawal of consent. Multivariate landmark analyses from the time of sHDCT showed superior PFS and OS (p= 0.0087/0.0057) in patients who received sHDCT/ASCT. Incorporation of sHDCT/ASCT into relapse treatment with Rd was feasible in 71% of patients and did not significantly prolong PFS and OS on ITT analysis while patients who received sHDCT/ASCT may have benefitted.
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- 2021
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16. Publisher Correction: Bortezomib-based induction, high-dose melphalan and lenalidomide maintenance in myeloma up to 70 years of age
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Mai, Elias K., Miah, Kaya, Bertsch, Uta, Dürig, Jan, Scheid, Christof, Weisel, Katja C., Kunz, Christina, Munder, Markus, Lindemann, Hans-Walter, Merz, Maximilian, Hose, Dirk, Jauch, Anna, Seckinger, Anja, Luntz, Steffen, Sauer, Sandra, Fuhrmann, Stephan, Brossart, Peter, Elmaagacli, Ahmet, Goerner, Martin, Bernhard, Helga, Hoffmann, Martin, Raab, Marc S., Blau, Igor W., Hänel, Mathias, Benner, Axel, Salwender, Hans J., and Goldschmidt, Hartmut
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- 2024
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17. Bortezomib-based induction, high-dose melphalan and lenalidomide maintenance in myeloma up to 70 years of age
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Mai, Elias K., Miah, Kaya, Bertsch, Uta, Dürig, Jan, Scheid, Christof, Weisel, Katja C., Kunz, Christina, Munder, Markus, Lindemann, Hans-Walter, Merz, Maximilian, Hose, Dirk, Jauch, Anna, Seckinger, Anja, Luntz, Steffen, Sauer, Sandra, Fuhrmann, Stephan, Brossart, Peter, Elmaagacli, Ahmet, Goerner, Martin, Bernhard, Helga, Hoffmann, Martin, Raab, Marc S., Blau, Igor W., Hänel, Mathias, Benner, Axel, Salwender, Hans J., and Goldschmidt, Hartmut
- Abstract
Intensive upfront therapy in newly-diagnosed multiple myeloma (MM) including induction therapy (IT), high-dose melphalan (MEL200), and autologous blood stem cell transplantation (ASCT) followed by consolidation and/or maintenance is mostly restricted to patients up to 65 years of age. Prospective phase III trial data in the era of novel agents for patients up to 70 years of age are not available. The GMMG-MM5 trial included 601 patients between 18 and 70 years of age, divided in three groups for the present analysis: ≤60 years (S1, n= 353), 61–65 years (S2, n= 107) and 66–70 years (S3, n= 141). Treatment consisted of a bortezomib-containing IT, MEL200/ASCT, consolidation, and maintenance with lenalidomide. Adherence to treatment was similar among patients of the three age groups. Overall toxicity during all treatment phases was increased in S2 and S3 compared to S1 (any adverse event/any serious adverse event: S1:81.7/41.8% vs. S2:90.7/56.5% vs. S3:87.2/68.1%, p= 0.05/<0.001). With respect to progression-free survival (log-rank p= 0.73), overall survival (log-rank p= 0.54) as well as time-to-progression (Gray’s p= 0.83) and non-relapse mortality (Gray’s p= 0.25), no differences were found between the three age groups. Our results imply that an intensive upfront therapy with a bortezomib-containing IT, MEL200/ASCT, lenalidomide consolidation, and maintenance should be applied to transplant-eligible MM patients up to 70 years of age.
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- 2021
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18. Selective elimination of immunosuppressive T cells in patients with multiple myeloma
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Awwad, Mohamed H. S., Mahmoud, Abdelrahman, Bruns, Heiko, Echchannaoui, Hakim, Kriegsmann, Katharina, Lutz, Raphael, Raab, Marc S., Bertsch, Uta, Munder, Markus, Jauch, Anna, Weisel, Katja, Maier, Bettina, Weinhold, Niels, Salwender, Hans Jürgen, Eckstein, Volker, Hänel, Mathias, Fenk, Roland, Dürig, Jan, Brors, Benedikt, Benner, Axel, Müller-Tidow, Carsten, Goldschmidt, Hartmut, and Hundemer, Michael
- Abstract
Elimination of suppressive T cells may enable and enhance cancer immunotherapy. Here, we demonstrate that the cell membrane protein SLAMF7 was highly expressed on immunosuppressive CD8+CD28-CD57+Tregs in multiple myeloma (MM). SLAMF7 expression associated with T cell exhaustion surface markers and exhaustion-related transcription factor signatures. T cells from patients with a high frequency of SLAMF7+CD8+T cells exhibited decreased immunoreactivity towards the MART-1aa26–35*A27Lantigen. A monoclonal anti-SLAMF7 antibody (elotuzumab) specifically depleted SLAMF7+CD8+T cells in vitro and in vivo via macrophage-mediated antibody-dependent cellular phagocytosis (ADCP). Anti-SLAMF7 treatment of MM patients depleted suppressive T cells in peripheral blood. These data highlight SLAMF7 as a marker for suppressive CD8+Treg and suggest that anti-SLAMF7 antibodies can be used to boost anti-tumoral immune responses in cancer patients.
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- 2021
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19. A New Risk Stratification Model (R2-ISS) in Newly Diagnosed Multiple Myeloma: Analysis of Mature Data from 7077 Patients Collected By European Myeloma Network within Harmony Big Data Platform
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D'Agostino, Mattia, Lahuerta, Juan-José, Wester, Ruth, Waage, Anders, Bertsch, Uta, Zamagni, Elena, Mateos, Maria-Victoria, Larocca, Alessandra, Dall'Olio, Daniele, van de Donk, Niels W. C. J., Cairns, David, Rocchi, Serena, Salwender, Hans, Blade Creixenti, Joan, van der Holt, Bronno, Gastone, Castellani, Ciccone, Giovannino, Capra, Andrea, Dürig, Jan, Bringhen, Sara, Zweegman, Sonja, Cavo, Michele, Goldschmidt, Hartmut, Cook, Gordon, Hernández-Rivas, Jesus Maria, San-Miguel, Jesus F., Boccadoro, Mario, and Sonneveld, Pieter
- Abstract
D'Agostino: GSK: Membership on an entity's Board of Directors or advisory committees. Waage:Janssen: Consultancy, Honoraria, Speakers Bureau; Takeda: Consultancy; Shire: Honoraria. Zamagni:Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses, Speakers Bureau; Takeda: Honoraria, Other: Travel, Accommodations, Expenses, Speakers Bureau; Celgene Corporation: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses, Speakers Bureau; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses, Speakers Bureau. Mateos:Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Honoraria, Membership on an entity's Board of Directors or advisory committees; Oncopeptides: Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen-Cilag: Consultancy, Honoraria; PharmaMar-Zeltia: Consultancy; Pfizer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Regeneron: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie/Genentech: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Adaptive Biotechnologies: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; GlaxoSmithKline: Consultancy; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Larocca:Takeda: Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; GSK: Honoraria. van de Donk:Takeda: Other: Ad Board; Genentech: Other: Ad Board; Bayer: Other: Ad Board; BMS: Other: Ad Board, Research Funding; Amgen: Other: Ad Board, Research Funding; Celgene: Other: Ad Board, Research Funding; Novartis: Other: Ad Board; Janssen: Other: Ad Board, Research Funding. Cairns:Celgene, Amgen, Merck: Research Funding; Celgene: Other: Travel Support. Salwender:Takeda: Honoraria; Bristol-Myers Squibb/Celgene: Honoraria; Janssen-Cilag: Honoraria; Amgen: Honoraria; Oncopeptides: Honoraria; Sanofi: Honoraria; GlaxoSmithKline: Honoraria; AbbVie: Honoraria. Blade Creixenti:Oncopeptides: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees. Dürig:Janssen: Consultancy; AbbVie: Consultancy; Celgene: Consultancy. Bringhen:Karyopharm: Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Honoraria; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Zweegman:Sanofi: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding. Cavo:AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel accomodations, Speakers Bureau; GlaxoSmithKline: Honoraria, Speakers Bureau; Karyopharm: Honoraria; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel accomodations, Speakers Bureau; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Goldschmidt:Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Grants and/or provision of Investigational Medicinal Product:, Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Grants and/or provision of Investigational Medicinal Product:, Research Funding; Dietmar-Hopp-Foundation: Other: Grants and/or provision of Investigational Medicinal Product:; Molecular Partners: Research Funding; Merck Sharp and Dohme (MSD): Research Funding; Novartis: Honoraria, Research Funding; Johns Hopkins University: Other: Grants and/or provision of Investigational Medicinal Product; Chugai: Honoraria, Other: Grants and/or provision of Investigational Medicinal Product:, Research Funding; Incyte: Research Funding; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Grants and/or provision of Investigational Medicinal Product:, Research Funding; University Hospital Heidelberg, Internal Medicine V and National Center for Tumor Diseases (NCT), Heidelberg, Germany: Current Employment; GlaxoSmithKline (GSK): Honoraria; Adaptive Biotechnology: Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Grants and/or provision of Investigational Medicinal Product, Research Funding; Mundipharma GmbH: Research Funding; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other, Research Funding. Cook:Celgene: Consultancy, Research Funding; Janssen: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; IQVIA: Research Funding; Sanofi: Consultancy; Amgen: Consultancy; Roche: Consultancy; Karyopharm: Consultancy. San-Miguel:Amgen, BMS, Celgene, Janssen, MSD, Novartis, Takeda, Sanofi, Roche, Abbvie, GlaxoSmithKline and Karyopharm: Consultancy, Membership on an entity's Board of Directors or advisory committees. Boccadoro:Sanofi: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Amgen: Honoraria, Research Funding; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria, Research Funding; AbbVie: Honoraria; Mundipharma: Research Funding; GlaxoSmithKline: Membership on an entity's Board of Directors or advisory committees. Sonneveld:Bristol-Myers Squibb: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria, Research Funding; Skyline Dx: Honoraria, Research Funding; Karyopharm: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Sanofi: Consultancy.The presentation includes discussion of off-label use of a drug or drugs for the treatment of multiple myeloma.
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- 2020
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20. Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial
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Goldschmidt, Hartmut, Mai, Elias K., Dürig, Jan, Scheid, Christof, Weisel, Katja C., Kunz, Christina, Bertsch, Uta, Hielscher, Thomas, Merz, Maximilian, Munder, Markus, Lindemann, Hans-Walter, Hügle-Dörr, Barbara, Tichy, Diana, Giesen, Nicola, Hose, Dirk, Seckinger, Anja, Huhn, Stefanie, Luntz, Steffen, Jauch, Anna, Elmaagacli, Ahmet, Rabold, Bernhard, Fuhrmann, Stephan, Brossart, Peter, Goerner, Martin, Bernhard, Helga, Hoffmann, Martin, Hillengass, Jens, Raab, Marc S., Blau, Igor W., Hänel, Mathias, and Salwender, Hans J.
- Abstract
The MM5 trial aimed at demonstrating a progression-free survival (PFS) difference in continued vs. response-adapted (in case of complete response, CR) lenalidomide (LEN) maintenance therapy (MT) in newly diagnosed, transplant-eligible multiple myeloma (MM). Patients were equally randomized to receive induction therapy with PAd (bortezomib/doxorubicin/dexamethasone) or VCD (bortezomib/cyclophosphamide/dexamethasone), high-dose melphalan and autologous blood stem cell transplantation, and LEN consolidation, followed by either LEN MT for a fixed duration of 2 years (LEN-2Y) or until achievement of CR (LEN-CR, intention-to-treat population n= 502): arms A1:PAd + LEN-2Y (n= 125), B1:PAd + LEN-CR (n= 126), A2:VCD + LEN-2Y (n= 126), B2:VCD + LEN-CR (n= 125). In the LEN-CR group (B1 + B2), n= 88/17.5% patients did not start or discontinued LEN MT due to CR. There was no PFS (p= 0.60, primary endpoint) nor overall survival (OS) (p= 0.15) difference between the four study arms. On pooled LEN MT strategies, OS (hazard ratio, hazard ratio [HR] = 1.42, p= 0.03) but not PFS (HR = 1.15, p= 0.20) was shorter in LEN-CR (B1 + B2) vs. LEN-2Y (A1 + A2) groups. PFS was shortened on landmark analyses from the start of LEN MT in patients being in CR in the LEN-CR group (LEN-CR vs. LEN-2Y, HR = 1.84, p= 0.02). OS from first progression was shortened in the LEN-CR vs. LEN-2Y group (HR = 1.60, p= 0.01). LEN MT should be applied beyond CR for at least 2 years.
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- 2020
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21. Functional and clinical characterization of the alternatively spliced isoform AML1-ETO9ain adult patients with translocation t(8;21)(q22;q22.1) acute myeloid leukemia (AML)
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Agrawal, Mridul, Schwarz, Peggy, Giaimo, Benedetto Daniele, Bedzhov, Ivan, Corbacioglu, Andrea, Weber, Daniela, Gaidzik, Verena I., Jahn, Nikolaus, Rücker, Frank G., Schroeder, Thomas, Kindler, Thomas, Wattad, Mohammed, Götze, Katharina, Lübbert, Michael, Salwender, Hans, Ringhoffer, Mark, Lange, Elisabeth, Koller, Elisabeth, Thol, Felicitas, Heuser, Michael, Ganser, Arnold, Bullinger, Lars, Paschka, Peter, Döhner, Hartmut, Geiger, Hartmut, Borggrefe, Tilman, Döhner, Konstanze, and Oswald, Franz
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- 2020
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22. Immunological Subgroups Predicting Efficacy of Elotuzumab in Multiple Myeloma Patients: Insights from the GMMG-HD6 Clinical Trial
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Ton, Gigi Nu Hoang Quy, Kriegsmann, Katharina, Awwad, Mohamed H.S., Benner, Axel, Bertsch, Uta, Besemer, Britta, Hänel, Mathias, Fenk, Roland, Schlenzka, Jana, Munder, Markus, Dürig, Jan, Blau, Igor Wolfgang, Huhn, Stefanie, Hose, Dirk, Jauch, Anna, Neubauer, Andreas, Weinhold, Niels, Scheid, Christof, Schroers, Roland, von Metzler, Ivana, Schieferdecker, Aneta, Thomalla, Jörg, Reimer, Peter, Mahlberg, Rolf, Graeven, Ullrich, Kremers, Stephan, Martens, Uwe, Kunz, Christian, Hensel, Manfred, Seidel-Glätzer, Andrea, Weisel, Katja, Salwender, Hans, Müller-Tidow, Carsten, Raab, Marc S., Goldschmidt, Hartmut, Mai, Elias K., and Hundemer, Michael
- Abstract
Introduction: Elotuzumab, a monoclonal antibody targeting SLAM family member 7 protein (SLAMF7) on multiple myeloma (MM) cells, has shown promise in relapsed/refractory MM when combined with immunomodulatory agents. However, its effectiveness in newly diagnosed patients did not show improved progression-free survival (PFS) nor overall survival. In a previous study we demonstrated that elotuzumab specifically depleted high SLAMF7 expressing regulatory CD8 +T cells by macrophage induced antibody dependent phagocytosis. This study aimed to identify immunological predictive factors for elotuzumab efficacy, enabling improved risk stratification and personalized treatment decisions based on the detection and quantification of SLAMF7-positive T cell subsets.
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- 2023
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23. Salvage Autologous Transplant and Lenalidomide Maintenance Versus Continuous Lenalidomide/Dexamethasone for Relapsed Multiple Myeloma: Long Term Follow up Results of the Randomized GMMG Phase III Multicenter Trial Relapse
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Baertsch, Marc-Andrea, Schlenzka, Jana, Hielscher, Thomas, Raab, Marc S., Sauer, Sandra, Merz, Maximilian, Mai, Elias K., Müller-Tidow, Carsten, Luntz, Steffen, Jauch, Anna, Brossart, Peter, Goerner, Martin, Klein, Stefan, Glass, Bertram, Reimer, Peter, Graeven, Ullrich, Fenk, Roland, Hänel, Mathias, von Metzler, Ivana, Hans W., Lindemann, Scheid, Christof, Nogai, Axel, Salwender, Hans, Noppeney, Richard, Besemer, Britta, Weisel, Katja, and Goldschmidt, Hartmut
- Abstract
IntroductionThe randomized, controlled, multicenter, phase III GMMG ReLApsE trial compared lenalidomide/dexamethasone (Rd) re-induction, salvage high dose chemotherapy, autologous stem cell transplantation (HDCT/ASCT) and lenalidomide (R) maintenance with standard continuous Rd. We have previously reported the absence of a significant survival benefit in the primary analysis. However, landmark analyses from salvage HDCT performed due to the fact that ~30% of patients in the HDCT arm did not receive salvage HDCT/ASCT suggested a survival benefit in patients undergoing salvage HDCT/ASCT. Here we report long term follow up results from the GMMG ReLApsE trial.
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- 2023
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24. Midostaurin added to chemotherapy and continued single-agent maintenance therapy in acute myeloid leukemia with FLT3-ITD
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Schlenk, Richard F., Weber, Daniela, Fiedler, Walter, Salih, Helmut R., Wulf, Gerald, Salwender, Hans, Schroeder, Thomas, Kindler, Thomas, Lübbert, Michael, Wolf, Dominik, Westermann, Jörg, Kraemer, Doris, Götze, Katharina S., Horst, Heinz-August, Krauter, Jürgen, Girschikofsky, Michael, Ringhoffer, Mark, Südhoff, Thomas, Held, Gerhard, Derigs, Hans-Günter, Schroers, Roland, Greil, Richard, Grießhammer, Martin, Lange, Elisabeth, Burchardt, Alexander, Martens, Uwe, Hertenstein, Bernd, Marretta, Lore, Heuser, Michael, Thol, Felicitas, Gaidzik, Verena I., Herr, Wolfgang, Krzykalla, Julia, Benner, Axel, Döhner, Konstanze, Ganser, Arnold, Paschka, Peter, and Döhner, Hartmut
- Abstract
Patients with acute myeloid leukemia (AML) and a FLT3internal tandem duplication (ITD) have poor outcomes to current treatment. A phase 2 hypothesis-generating trial was conducted to determine whether the addition of the multitargeted kinase inhibitor midostaurin to intensive chemotherapy followed by allogeneic hematopoietic cell transplantation (alloHCT) and single-agent maintenance therapy of 12 months is feasible and favorably influences event-free survival (EFS) compared with historical controls. Patients 18 to 70 years of age with newly diagnosed AML and centrally confirmed FLT3-ITD were eligible: 284 patients were treated, including 198 younger (18-60 years) and 86 older (61-70 years) patients. Complete remission (CR) rate, including CR with incomplete hematological recovery (CRi) after induction therapy, was 76.4% (younger, 75.8%; older, 77.9%). The majority of patients in CR/CRi proceeded to alloHCT (72.4%). Maintenance therapy was started in 97 patients (34%): 75 after alloHCT and 22 after consolidation with high-dose cytarabine (HiDAC). Median time receiving maintenance therapy was 9 months after alloHCT and 10.5 months after HiDAC; premature termination was mainly a result of nonrelapse causes (gastrointestinal toxicity and infections). EFS and overall survival at 2 years were 39% (95% confidence interval [CI], 33%-47%) and 34% (95% CI, 24%-47%) and 53% (95% CI, 46%-61%) and 46% (95% CI, 35%-59%) in younger and older patients, respectively. EFS was evaluated in comparison with 415 historical controls treated within 5 prospective trials. Propensity score-weighted analysis revealed a significant improvement of EFS by midostaurin (hazard ratio [HR], 0.58; 95% CI, 0.48-0.70; P< .001) overall and in older patients (HR, 0.42; 95% CI, 0.29-0.61). The study was registered at www.clinicaltrials.govas #NCT01477606.
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- 2019
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25. Bortezomib-based induction therapy with high or low-dose dexamethasone in newly diagnosed, transplant-eligible multiple myeloma
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Mai, Elias, Hielscher, Thomas, Bertsch, Uta, Schlenzka, Jana, Salwender, Hans, Munder, Markus, Gerecke, Christian, Dührsen, Ulrich, Brossart, Peter, Neben, Kai, Hillengass, Jens, Raab, Marc, Merz, Maximilian, Baertsch, Marc-Andrea, Jauch, Anna, Hose, Dirk, Martin, Hans, Lindemann, Hans-Walter, Blau, Igor, Scheid, Christof, Weisel, Katja, and Goldschmidt, Hartmut
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- 2019
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26. Long-Term Outcome of a Prospective Randomized Trial Comparing Continuous Lenalidomide/Dexamethasone with Lenalidomide/Dexamethasone Induction, MEL140 with Autologous Blood Stem Cell Transplantation and Single Agent Lenalidomide Maintenance in Patients of Age 60-75 Years with Newly Diagnosed Multiple Myeloma
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Straka, Christian, Schaefer-Eckart, Kerstin, Hertenstein, Bernd, Bassermann, Florian, Salwender, Hans, Langer, Christian, Krönke, Jan, Kull, Miriam, Schilling, Georgia, Schieferdecker, Aneta, Engelhardt, Monika, Knop, Stefan, Reusch, Julia, Roesler, Wolf, Metzner, Bernd, Hebart, Holger, Reichle, Albrecht, Grube, Matthias, Frickhofen, Norbert, Gerecke, Christian, Fuhrmann, Stephan, Jung, Wolfram, Gramatzki, Martin, Decker, Thomas, Dechow, Tobias, Greiner, Jochen, Brümmendorf, Tim H., Ababei, Juliana, Metzler, Ivana von, Naumann, Ralph, Fritz, Elisabeth, Hentrich, Marcus, Bojko, Peter, Kubin, Thomas, Schmidt, Christian, Kaufmann, Martin, Schmidt, Burkhard, Hinke, Axel, and Einsele, Hermann
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- 2022
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27. Prognostic significance of cytogenetic heterogeneity in patients with newly diagnosed multiple myeloma
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Merz, Maximilian, Jauch, Anna, Hielscher, Thomas, Bochtler, Tilmann, Schönland, Stefan Olaf, Seckinger, Anja, Hose, Dirk, Bertsch, Uta, Neben, Kai, Raab, Marc Steffen, Hillengass, Jens, Salwender, Hans, Blau, Igor Wolfgang, Lindemann, Hans-Walter, Schmidt-Wolf, Ingo G. H., Scheid, Christof, Haenel, Mathias, Weisel, Katja C., and Goldschmidt, Hartmut
- Abstract
We investigated subclonal cytogenetic aberrations (CA) detected by interphase fluorescence in situ hybridization (iFISH) in patients with newly diagnosed multiple myeloma (MM) enrolled in the Haemato Oncology Foundation for Adults in the Netherlands (HOVON)–65/German-Speaking MM Group (GMMG)–HD4 phase 3 trial. Patients were either treated with 3 cycles of vincristine, Adriamycin, and dexamethasone or bortezomib, Adriamycin, and dexamethasone and then thalidomide or bortezomib maintenance after tandem autologous transplantation. Subclones were defined either by presence of different copy numbers of the same chromosome loci and/or CA present in at least 30% less and maximally 2/3 of cells compared with the main clone CA. Patients with subclones harbored more frequently high risk (31.0%) or hyperdiploid main clone aberrations (24.8%) than patients with t(11;14) in the main clone (10.1%). Gains and deletions of c-MYC were the only CA that occurred more frequently as subclone (8.1%/20.5%) than main clone (6.2%/3.9%, respectively). Treatment with bortezomib completely overcame the negative prognosis of high-risk CA in patients without subclones, but not in patients with additional subclonal CA. High-risk patients treated without bortezomib showed dismal outcome whether subclones were present or not. Cytogenetic heterogeneity defined by subclonal CA is of major prognostic significance in newly diagnosed MM patients treated with bortezomib within the HOVON-65/GMMG-HD4 trial.
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- 2018
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28. Effects on Survival of Non-Myeloablative Chemoimmunotherapy Compared to High-Dose Chemotherapy Followed By Autologous Stem Cell Transplantation (HDC-ASCT) As Consolidation Therapy in Patients with Primary CNS Lymphoma - Results of an International Randomized Phase III Trial (MATRix/IELSG43)
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Illerhaus, Gerald, Ferreri, Andrés J.M., Binder, Mascha, Borchmann, Peter, Hasenkamp, Justin, Stilgenbauer, Stephan, Roeth, Alexander, Weber, Thomas, Egerer, Gerlinde, Ernst, Thomas, Hertenstein, Bernd, Lenz, Georg, Kobbe, Guido, Brunnberg, Uta, Schmidt, Christian, Kneba, Michael, Dreyling, Martin, Möhle, Robert, Panse, Jens, Heinicke, Thomas, Schroll, Sebastian, Larsen, Thomas S., Salwender, Hans, Naumann, Ralph, Hess, Georg, Thurner, Lorenz, Pukrop, Tobias, Keller, Ulrich, Blystadt, Anne Kirsti, Kroschinsky, Frank P., Re, Francesca, Pulczynski, Elisa, Orsucci, Lorella, Pospiech, Lisa, Deckert, Martina, Ponzoni, Maurilio, Wendler, Julia, Valk, Elke, Calimeri, Teresa, Kasenda, Benjamin, Trepel, Martin, Fricker, Heidi, von Gottberg, Philipp, Burger, Elvira, Ihorst, Gabriele, Grishina, Olga, Hader, Claudia, Zucca, Emanuele, Finke, Jürgen, and Schorb, Elisabeth
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- 2022
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29. Midostaurin plus Intensive Chemotherapy for Younger and Older Patients with AML and FLT3Internal Tandem Duplications
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Döhner, Hartmut, Weber, Daniela, Krzykalla, Julia, Fiedler, Walter, Wulf, Gerald, Salih, Helmut, Lübbert, Michael, Kühn, Michael W.M., Schroeder, Thomas, Salwender, Hans, Götze, Katharina, Westermann, Jörg, Fransecky, Lars, Mayer, Karin, Hertenstein, Bernd, Ringhoffer, Mark, Tischler, Hans-Joachim, Machherndl-Spandl, Sigrid, Schrade, Anika, Paschka, Peter, Gaidzik, Verena I., Theis, Frauke, Thol, Felicitas, Heuser, Michael, Schlenk, Richard F., Bullinger, Lars, Saadati, Maral, Benner, Axel, Larson, Richard, Stone, Richard, Döhner, Konstanze, and Ganser, Arnold
- Abstract
We conducted a single-arm phase-II trial (AMLSG 16-10) to evaluate midostaurin with intensive chemotherapy followed by allogeneic hematopoietic-cell transplantation (HCT) and a one-year midostaurin maintenance therapy in adult patients with acute myeloid leukemia (AML) and FLT3internal tandem duplication (ITD). Patients 18-70 years of age with newly diagnosed FLT3-ITD-positive AML were eligible. Primary and key secondary endpoints were event-free (EFS) and overall survival (OS). Results were compared to a historical cohort of 415 patients treated on 5 prior AMLSG trials; statistical analysis was performed using a double-robust adjustment with propensity score weighting and covariate adjustment. Results were also compared to patients (18-59yrs) treated on the placebo arm of the CALGB 10603/RATIFY trial. The trial accrued 440 patients (18-60yrs, n=312; 61-70yrs, n=128). In multivariate analysis, EFS was significantly in favor of patients treated within the AMLSG 16-10 trial compared to the AMLSG control (HR 0.55; P<0.001); both in younger (HR 0.59; P<0.001) and older patients (HR 0.42; P<0.001). Multivariate analysis also showed a significant beneficial effect on OS compared to the AMLSG control (HR 0.57; P<0.001) as well as to the CALGB 10603/RATIFY trial (HR 0.71; p=0.005). The treatment effect of midostaurin remained significant in sensitivity analysis including allogeneic HCT as a time-dependent covariate. Addition of midostaurin to chemotherapy was safe in younger and older patients. In comparison to historical controls, the addition of midostaurin to intensive therapy led to a significant improvement in outcome in younger and older patients with AML and FLT3-ITD. The AMLSG 16-10 trial is registered at clinicaltrialsregistry.eu(Eudra-CT number 2011-003168-63) and clinicaltrials.gov(NCT01477606).
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- 2022
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30. Next-Generation Sequencing (NGS)-Based Measurable Residual Disease (MRD) Monitoring in Acute Myeloid Leukemia with FLT3 Internal Tandem Duplication (FLT3-ITD+ AML) Treated with Additional Midostaurin
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Herzig, Julia K., Rücker, Frank G., Schmalbrock, Laura K., Blätte, Tamara J., Weber, Daniela, Skambraks, Sabrina, Kapp-Schwoerer, Silke, Corbacioglu, Andrea, Gaidzik, Verena I, Paschka, Peter, Panina, Ekaterina, Jahn, Nikolaus, Schrade, Anika, Theis, Frauke, Cocciardi, Sibylle, Fiedler, Walter, Salih, Helmut R., Wulf, Gerald, Salwender, Hans, Schroeder, Thomas, Götze, Katharina S., Kindler, Thomas, Luebbert, Michael, Schlenk, Richard F., Thol, Felicitas, Heuser, Michael, Ganser, Arnold, Döhner, Hartmut, Bullinger, Lars, and Döhner, Konstanze
- Abstract
Kapp-Schwoerer: Jazz Pharmaceuticals: Honoraria, Research Funding. Paschka:Sunesis Pharmaceuticals: Consultancy; BerGenBio ASA: Research Funding; Novartis: Consultancy, Speakers Bureau; Otsuka: Consultancy; Pfizer: Consultancy, Speakers Bureau; Astellas Pharma: Consultancy, Speakers Bureau; Celgene: Consultancy, Other: Travel, accommodations or expenses; Astex Pharmaceuticals: Consultancy; Jazz Pharmaceuticals: Consultancy, Speakers Bureau; Agios Pharmaceuticals: Consultancy, Speakers Bureau; Amgen: Other; Janssen Oncology: Other; AbbVie: Other: Travel, accommodation or expenses, Speakers Bureau. Fiedler:Ariad/Incyte: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; Jazz Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accomodations; Novartis: Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: support in medical writing; Daiichi Sankyo Oncology: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accomodations; Morphosys: Membership on an entity's Board of Directors or advisory committees; BMS: Honoraria; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: support in medical writing; Servier: Honoraria, Other; BerGenBio ASA: Research Funding; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accomodations, support in medical writing, Research Funding; Gilead: Honoraria. Salih:Novartis: Consultancy; Pfizer: Consultancy; Philogen: Consultancy; Medigene: Consultancy; Synimmune: Consultancy, Research Funding. Salwender:Bristol-Myers Squibb/Celgene: Honoraria; Janssen-Cilag: Honoraria; Amgen: Honoraria; Takeda: Honoraria; Oncopeptides: Honoraria; Sanofi: Honoraria; GlaxoSmithKline: Honoraria; AbbVie: Honoraria. Götze:Celgene: Research Funding. Luebbert:Janssen: Research Funding. Schlenk:PharmaMar: Research Funding; Daiichi Sankyo: Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accomodations, Expenses, Research Funding, Speakers Bureau; Novartis: Speakers Bureau; Roche: Research Funding; AstraZeneca: Research Funding; Pfizer: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Thol:Daiichi Sankyo: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; Astellas: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees. Heuser:Daiichi Sankyo: Consultancy, Research Funding; Pfizer: Consultancy, Honoraria, Research Funding; Karyopharm: Research Funding; Abbvie: Consultancy; PriME Oncology: Honoraria; Amgen: Research Funding; Astellas: Research Funding; Roche: Research Funding; Stemline Therapeutics: Consultancy; Novartis: Consultancy, Honoraria, Research Funding; Janssen: Consultancy; BerGenBio ASA: Research Funding; Bayer: Consultancy, Research Funding. Ganser:Novartis: Consultancy; Celgene: Consultancy. Döhner:AstraZeneca: Consultancy, Honoraria; Sunesis: Research Funding; Roche: Consultancy, Honoraria; Pfizer: Research Funding; Oxford Biomedicals: Consultancy, Honoraria; Novartis: Consultancy, Honoraria, Research Funding; Helsinn: Consultancy, Honoraria; Jazz: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Bristol Myers Squibb: Consultancy, Honoraria, Research Funding; Astex: Consultancy, Honoraria; Astellas: Consultancy, Honoraria, Research Funding; AROG: Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Agios: Consultancy, Honoraria, Research Funding; Abbvie: Consultancy, Honoraria; GEMoaB: Consultancy, Honoraria. Bullinger:Jazz Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Menarini: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees; Astellas: Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees; Gilead: Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; Daiichi Sankyo: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees; Hexal: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees. Döhner:Jazz Pharmaceuticals: Consultancy, Honoraria, Research Funding; Daiichi Sankyo: Honoraria; Celgene: Consultancy, Honoraria; Sunesis Pharmaceuticals: Research Funding; Novartis: Honoraria, Research Funding; Pfizer: Research Funding; Bristol-Myers Squibb: Research Funding; Arog: Research Funding; Roche: Consultancy; Astex Pharmaceuticals: Consultancy; Janssen: Consultancy, Honoraria; Amgen: Consultancy, Research Funding; Astellas Pharma: Consultancy; Agios: Consultancy; Abbvie: Consultancy.
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- 2020
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31. Next-Generation Sequencing (NGS)-Based Measurable Residual Disease (MRD) Monitoring in Acute Myeloid Leukemia with FLT3Internal Tandem Duplication (FLT3-ITD+AML) Treated with Additional Midostaurin
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Herzig, Julia K., Rücker, Frank G., Schmalbrock, Laura K., Blätte, Tamara J., Weber, Daniela, Skambraks, Sabrina, Kapp-Schwoerer, Silke, Corbacioglu, Andrea, Gaidzik, Verena I, Paschka, Peter, Panina, Ekaterina, Jahn, Nikolaus, Schrade, Anika, Theis, Frauke, Cocciardi, Sibylle, Fiedler, Walter, Salih, Helmut R., Wulf, Gerald, Salwender, Hans, Schroeder, Thomas, Götze, Katharina S., Kindler, Thomas, Luebbert, Michael, Schlenk, Richard F., Thol, Felicitas, Heuser, Michael, Ganser, Arnold, Döhner, Hartmut, Bullinger, Lars, and Döhner, Konstanze
- Abstract
Background:FLT3-ITD occurs in ~25% of adult AML patients (pts) and is associated with poor prognosis. MRD monitoring is of high prognostic relevance, but restricted to certain AML subtypes. FLT3-ITD represents an attractive target for MRD monitoring in particular in pts treated with a tyrosine kinase inhibitor. FLT3-ITD MRD monitoring is hampered by the broad heterogeneity of ITD length and insertion site (IS). NGS may overcome these limitations offering the opportunity for MRD monitoring in FLT3-ITD+AML.
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- 2020
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32. Administration of bortezomib before and after autologous stem cell transplantation improves outcome in multiple myeloma patients with deletion 17p
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Neben, Kai, Lokhorst, Henk M., Jauch, Anna, Bertsch, Uta, Hielscher, Thomas, van der Holt, Bronno, Salwender, Hans, Blau, Igor W., Weisel, Katja, Pfreundschuh, Michael, Scheid, Christof, Dührsen, Ulrich, Lindemann, Walter, Schmidt-Wolf, Ingo G. H., Peter, Norma, Teschendorf, Christian, Martin, Hans, Haenel, Mathias, Derigs, Hans G., Raab, Marc S., Ho, Anthony D., van de Velde, Helgi, Hose, Dirk, Sonneveld, Pieter, and Goldschmidt, Hartmut
- Abstract
In patients with multiple myeloma (MM), risk stratification by chromosomal abnormalities may enable a more rational selection of therapeutic approaches. In the present study, we analyzed the prognostic value of 12 chromosomal abnormalities in a series of 354 MM patients treated within the HOVON-65/GMMG-HD4 trial. Because of the 2-arm design of the study, we were able to analyze the effect of a bortezomib-based treatment before and after autologous stem cell transplantation (arm B) compared with standard treatment without bortezomib (arm A). For allanalyzed chromosomal aberrations, progression-free survival (PFS) and overall survival (OS) were at least equal or superior in the bortezomib arm compared with the standard arm. Strikingly, patients with del(17p13) benefited the most from the bortezomib-containing treatment: the median PFS in arm A was 12.0 months and in arm B it was 26.2 months (P = .024); the 3 year-OS for arm A was 17% and for arm B it was 69% (P = .028). After multivariate analysis, del(17p13) was an independent predictor for PFS (P < .0001) and OS (P < .0001) in arm A, whereas no statistically significant effect on PFS (P = .28) or OS (P = .12) was seen in arm B. In conclusion, the adverse impact of del(17p13) on PFS and OS could be significantly reduced by bortezomib-based treatment, suggesting that long-term administration of bortezomib should be recommended for patients carrying del(17p13). This trial is registered at the International Standard Randomised Controlled Trial Number Register as ISRCTN64455289.
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- 2012
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33. Testing G-CSF responsiveness predicts the individual susceptibility to infection and consecutive treatment in recipients of high-dose chemotherapy
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Straka, Christian, Sandherr, Michael, Salwender, Hans, Wandt, Hannes, Metzner, Bernd, Hübel, Kai, Silling, Gerda, Hentrich, Marcus, Franke, Daniel, Schwerdtfeger, Rainer, Freund, Mathias, Sezer, Orhan, Giagounidis, Alexander, Ehninger, Gerhard, Grimminger, Wolfgang, Engert, Andreas, Schlimok, Günter, Scheid, Christof, Hellmann, Peter, Heinisch, Harald, Einsele, Hermann, Hinke, Axel, and Emmerich, Bertold
- Abstract
The individual risk of infection and requirements for medical treatment after high-dose chemotherapy have been unpredictable. In this prospective, multicenter, open-label study we investigated the potential of granulocyte colony-stimulating factor (G-CSF) responsiveness as a predictor. A total of 168 patients with multiple myeloma or lymphoma received a single dose of subcutaneous G-CSF (lenograstim, 263 μg) after high-dose chemotherapy. Highly variable leukocyte peaks were measured and grouped as low (quartile 1; leukocytes 100-10 100/μL), medium (quartile 2; leukocytes > 10 100-18 300/μL), and high (quartiles 3/4; leukocytes > 18 300-44 800/μL). G-CSF responsiveness (low vs medium vs high) was inversely correlated with febrile neutropenia (77% vs 60% vs 48%; P = .0037); the rate of infection, including fever of unknown origin (91% vs 67% vs 54%; P < .0001); days with intravenous antibiotics (9 vs 6 vs 5; P < .0001); and antifungal therapy (P = .042). In multivariate analysis, G-CSF responsiveness remained the only factor significantly associated with infection (P = .016). In addition, G-CSF responsiveness was inversely correlated with grade 3/4 oral mucositis (67% vs 33% vs 23%; P < .0001). G-CSF responsiveness appears as a signature of the myeloid marrow reserve predicting defense against neutropenic infection after intensive chemotherapy. This study is registered at http://www.clinicaltrials.gov as NCT01085058.
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- 2011
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34. Addition of Isatuximab to Lenalidomide, Bortezomib and Dexamethasone As Induction Therapy for Newly-Diagnosed, Transplant-Eligible Multiple Myeloma Patients: The Phase III GMMG-HD7 Trial
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Goldschmidt, Hartmut, Mai, Elias K, Nievergall, Eva, Fenk, Roland, Bertsch, Uta, Tichy, Diana, Besemer, Britta, Dürig, Jan, Schroers, Roland, Metzler, Ivana v., Haenel, Mathias, Mann, Christoph, Asemissen, Anne-Marie, Heilmeier, Bernhard, Huhn, Stefanie, Kriegsmann, Katharina, Weinhold, Niels, Luntz, Steffen P., Holderried, Tobias A.W., Trautmann-Grill, Karolin, Gezer, Deniz, Klaiber-Hakimi, Maika, Mueller, Martin, Khandanpour, Cyrus, Knauf, Wolfgang, Munder, Markus, Geer, Thomas, Riesenberg, Hendrik, Thomalla, Joerg, Hoffmann, Martin, Raab, Marc-Steffen, Salwender, Hans, and Weisel, Katja
- Abstract
Background:In newly-diagnosed multiple myeloma (NDMM), lenalidomide/bortezomib/dexamethasone (RVd) is one of the most widely used combination regimens. Anti-CD38 monoclonal antibodies (CD38-moAb) increase efficacy when added to standard-of-care regimens. Here we present the first primary endpoint of the randomized, open-label, multicenter, phase III GMMG-HD7 trial, comparing RVd without (arm IA) or with the CD38-moAb isatuximab (Isa, arm IB) with regard to the rate of minimal residual disease (MRD) negativity after induction therapy in patients with transplant-eligible NDMM.
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- 2021
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35. Midostaurin Plus Intensive Chemotherapy for Younger and Older Patients with Acute Myeloid Leukemia and FLT3 Internal Tandem Duplications
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Döhner, Hartmut, Weber, Daniela, Krzykalla, Julia, Fiedler, Walter, Wulf, Gerald, Salih, Helmut R., Lübbert, Michael, Kühn, Michael W.M., Schroeder, Thomas, Salwender, Hans, Götze, Katharina S., Westermann, Jörg, Fransecky, Lars, Mayer, Karin, Hertenstein, Bernd, Ringhoffer, Mark, Tischler, Hans-Joachim, Machherndl-Spandl, Sigrid, Schrade, Anika, Paschka, Peter, Gaidzik, Verena I, Theis, Frauke, Thol, Felicitas R, Heuser, Michael, Schlenk, Richard F., Bullinger, Lars, Saadati, Maral, Benner, Axel, Döhner, Konstanze, and Ganser, Arnold
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- 2021
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36. Elotuzumab in Combination with Lenalidomide, Bortezomib, Dexamethasone and Autologous Transplantation for Newly-Diagnosed Multiple Myeloma: Results from the Randomized Phase III GMMG-HD6 Trial
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Goldschmidt, Hartmut, Mai, Elias K, Bertsch, Uta, Besemer, Britta, Haenel, Mathias, Miah, Kaya, Fenk, Roland, Schlenzka, Jana, Munder, Markus, Dürig, Jan, Blau, Igor Wolfgang, Huhn, Stefanie, Hose, Dirk, Jauch, Anna, Kunz, Christina, Neubauer, Andreas, Scheid, Christof, Schroers, Roland, Metzler, Ivana v., Schieferdecker, Aneta, Thomalla, Joerg, Reimer, Peter, Mahlberg, Rolf, Graeven, Ullrich, Kremers, Stephan, Martens, Uwe M., Kunz, Christian, Hensel, Manfred, Seidel-Glaetzer, Andrea, Weisel, Katja, Raab, Marc-Steffen, and Salwender, Hans
- Abstract
Background:Treatment regimens including a proteasome inhibitor, immunomodulating agent and a monoclonal antibody (moAb) play an emerging role in the treatment of newly-diagnosed multiple myeloma (NDMM). This multicenter phase III trial of the German-speaking Myeloma Multicenter Group (GMMG HD6) investigated the addition of the anti-SLAMF7 moAb elotuzumab to lenalidomide / bortezomib / dexamethasone (RVd) in induction and consolidation therapy as well as to lenalidomide maintenance treatment in transplant-eligible NDMM.
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- 2021
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37. Prediction of Early Death and Severe Infections during Novel Agent-Based Induction Therapy in Newly-Diagnosed Multiple Myeloma: An Intergroup Analysis from the German Speaking Myeloma Multicenter Group, the Dutch-Belgian Cooperative Trial Group for Hematology Oncology Foundation and the European Myeloma Network
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Mai, Elias K, Hielscher, Thomas, Bertsch, Uta, Salwender, Hans, Zweegman, Sonja, Munder, Markus, Pantani, Lucia, Brossart, Peter, Beksac, Meral, Blau, Igor Wolfgang, Raab, Marc-Steffen, Dürig, Jan, Giesen, Nicola, Besemer, Britta, Fenk, Roland, Reimer, Peter, van der Holt, Bronno, Haenel, Mathias, Metzler, Ivana v., Graeven, Ullrich, Boccadoro, Mario, Scheid, Christof, Dimopoulos, Meletios A., Weisel, Katja, Cavo, Michele, Sonneveld, Pieter, and Goldschmidt, Hartmut
- Abstract
Background:During the past decade, prognostic tools and outcomes of patients with newly-diagnosed multiple myeloma (NDMM) markedly improved. Data from clinical trials evaluating early morbidity and mortality including patients with transplant-eligible NDMM treated with novel agents are scarce. Thus, we aimed to analyze early morbidity and mortality in this patient cohort, devise and validate a predictive score to identify patients at risk.
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- 2021
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38. Final Overall Survival Results from BELLINI, a Phase 3 Study of Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma
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Kumar, Shaji, Harrison, Simon J, Cavo, Michele, de la Rubia, Javier, Popat, Rakesh, Gasparetto, Cristina J., Hungria, Vania, Salwender, Hans, Suzuki, Kenshi, Kim, Inho, Onishi, Maika, Ku, Grace, Pothacamury, Rajvineeth Kumar, Sehgal, Vasudha, Masud, Abdullah A., Ross, Jeremy A., Dobkowska, Edyta, and Moreau, Philippe
- Abstract
Background:Multiple myeloma (MM) is a heterogenous cancer of terminally differentiated plasma cells that typically express elevated levels of antiapoptotic proteins, such as BCL-2. Venetoclax (Ven), a highly selective, potent, oral BCL-2 inhibitor, induces apoptosis in MM cells, and when combined with bortezomib and dexamethasone showed promising efficacy in patients (pts) with relapsed/refractory MM (RRMM; Moreau et al. Blood. 2017;130:2392-2400). The Phase 3 BELLINI study primary analysis showed significantly improved response rates and progression-free survival (PFS) in pts with RRMM treated with Ven added to bortezomib and dexamethasone versus placebo (Pbo); however, increased mortality was observed in the Ven group (Kumar et al. Lancet Oncol. 2020;21:1630-1642). At the initial data cutoff (November 26, 2018), the PFS hazard ratio (HR) was 0.63 (95% CI, 0.44-0.90) and overall survival (OS) HR was 2.03 (95% CI, 1.04-3.95). Pts with t(11;14) translocation or high BCL2expression showed improved responses and PFS without increased mortality. Here, we present updated safety and efficacy data from the prespecified final OS analysis.
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- 2021
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39. Chlorhexidine and silver-sulfadiazine coated central venous catheters in haematological patients—a double-blind, randomised, prospective, controlled trial
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Ostendorf, Torben, Meinhold, Andrea, Harter, Christoph, Salwender, Hans, Egerer, Gerlinde, Geiss, Heinrich, Ho, Antony, and Goldschmidt, Hartmut
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- 2005
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40. Bortezomib-Based Induction and Maintenance Overcomes the Negative Prognostic Impact of Renal Impairment and del17p in Transplant-Eligible Myeloma Patients: Long Term Results from the Phase III HOVON-65/GMMG-HD4 Study after Median 137 Months Follow up
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Scheid, Christof, Lokhorst, Henk, Blau, Igor W, Van Der Holt, Bronno, Bertsch, Uta, Zweegman, Sonja, Weisel, Katja, Vellenga, Edo, Kersten, Marie José, Croockewit, Sandra, Mai, Elias K, Raymakers, Reinier, Hose, Dirk, Jauch, Anna, Hillengass, Jens, Stevens-Kroef, Marian, Raab, Marc S, Neben, Kai, Stilgenbauer, Stephan, Broyl, Annemiek, Lindemann, Hans-Walter, Bos, Gerard, Brossart, Peter, van Marwijk Kooij, Marinus, Ypma, Paula F, Dührsen, Ulrich, Schaafsma, Ron, Hielscher, Thomas, Salwender, Hans, Goldschmidt, Hartmut, and Sonneveld, Pieter
- Abstract
Scheid: Bristol Myers Squibb: Honoraria; Celgene: Honoraria; Amgen: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Research Funding; Takeda: Honoraria, Research Funding; Novartis: Honoraria, Research Funding. Bertsch:Celgene: Other: travel support; Sanofi: Other: travel support. Zweegman:Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees, Research Funding. Weisel:Celgene: Consultancy, Honoraria, Research Funding; Juno: Consultancy; Bristol-Myers Squibb: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria, Research Funding; GSK: Honoraria; Adaptive Biotech: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria. Kersten:Gilead: Honoraria; Kite Pharma: Honoraria, Research Funding; Amgen: Honoraria, Research Funding; Novartis: Honoraria; Bristol-Myers Squibb: Honoraria, Research Funding; Mundipharma: Honoraria, Research Funding; Miltenyi: Honoraria; Roche: Honoraria, Research Funding; Takeda Oncology: Research Funding; Celgene: Honoraria, Research Funding. Mai:Mundipharma: Other: travel support; Takeda: Honoraria, Other: travel support, Research Funding; Janssen: Consultancy, Honoraria, Other: travel support; Celgene: Consultancy, Honoraria, Other: travel support. Hillengass:Amgen: Consultancy, Honoraria; Janssen: Honoraria. Stilgenbauer:AbbVie, AstraZeneca, Celgene, Gilead Sciences, Inc., GSK, Hoffmann La-Roche, Janssen, Novartis: Consultancy, Honoraria, Research Funding, Speakers Bureau. Broyl:Celgene, amgen, Janssen,Takeda: Honoraria. Bos:Kiadis Pharma: Other: Shareholder (of Cytosen, acquired by Kiadis); Celgene: Research Funding. Dührsen:Amgen: Consultancy, Honoraria, Research Funding; CPT: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria; Roche: Honoraria, Research Funding; Teva: Honoraria; Novartis: Consultancy, Honoraria; Alexion: Honoraria; Gilead: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; Janssen: Honoraria; Celgene: Research Funding. Salwender:Celgene: Honoraria, Other: Travel or accommodations; Sanofi: Honoraria, Other: Travel or accommodations; Takeda: Honoraria, Other: Travel or accommodations; Bristol-Myers Squibb: Honoraria, Other: Travel or accommodations; AbbVie: Honoraria; Amgen: Honoraria, Other: Travel or accommodations; Janssen Cilag: Honoraria, Other: Travel or accommodations. Goldschmidt:Adaptive Biotechnology: Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Molecular Partners: Research Funding; Dietmar-Hopp-Stiftung: Research Funding; Mundipharma: Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Membership on an entity's Board of Directors or advisory committees, Research Funding; John-Hopkins University: Research Funding; Amgen: Consultancy, Research Funding; Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Chugai: Honoraria, Research Funding; John-Hopkins University: Research Funding; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; MSD: Research Funding; Janssen: Consultancy, Research Funding. Sonneveld:Amgen: Honoraria, Research Funding; BMS: Honoraria; Celgene: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Karyopharm: Honoraria, Research Funding; Takeda: Honoraria, Research Funding; SkylineDx: Research Funding.bortezomib maintenance thalidomide maintenance
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- 2019
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41. Updated Analysis of Bellini, a Phase 3 Study of Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma
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Moreau, Philippe, Harrison, Simon, Cavo, Michele, De La Rubia, Javier, Popat, Rakesh, Gasparetto, Cristina, Hungria, Vania T.M., Salwender, Hans, Suzuki, Kenshi, Kim, Inho, Gay, Francesca, Mikala, Gábor, Punnoose, Elizabeth A, Hong, Wan-Jen, Sood, Anjla, Jalaluddin, Muhammad, Ross, Jeremy A., Ward, James E., Maciag, Paulo C., and Kumar, Shaji K.
- Published
- 2019
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42. Patterns of Renal Recovery and Toxicity with Novel Agent-Based Induction Triplets in Newly Diagnosed Multiple Myeloma - an Analysis of Two Prospective Studies By the German DSMM Myeloma Study Group
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Bachmann, Friederike, Held, Swantje, Engelhardt, Monika, Langer, Christian, Wolleschak, Denise, Fleissner, Janik, Mügge, Lars-Olof, Duerk, Heinz, Schreder, Martin, Schaefer-Eckart, Kerstin, Blau, Igor-Wolfgang, Gramatzki, Martin, Liebisch, Peter, Reichle, Albrecht, Metzler, Ivana, Bassermann, Florian, Metzner, Bernd, Röllig, Christoph, Hertenstein, Bernd, Dechow, Tobias, Jung, Wolfram, Ostermann, Helmut, Hebart, Holger, Maschmeyer, Georg, Salwender, Hans Jürgen, von Lilienfeld-Toal, Marie, Eckardt, Kai-Uwe, Straka, Christian, Einsele, Hermann, and Knop, Stefan
- Abstract
Mügge: Celgene: Research Funding; Celgene, Janssen: Honoraria. Schreder:Janssen, Celgene: Consultancy, Honoraria. Schaefer-Eckart:Pfizer, Janssen, Celgene: Honoraria. Metzler:Bristol-Myers Squibb, Celgene: Consultancy, Honoraria. Hertenstein:RS Media: Research Funding. Maschmeyer:Gilead, Janssen Cilag, Astra Zeneca; BMS, Merk-Serono: Honoraria. Salwender:Janssen Cilag: Consultancy, Honoraria, Other: Travel grants; Celgene: Honoraria, Other: Travel grants; AMGEN: Honoraria, Other: Travel grants; Sanofi: Honoraria, Other: Travel grants; Bristol-Myers Squibb: Honoraria, Other: Travel grants; Takeda: Honoraria, Other: Travel grants; Oncopeptides: Honoraria, Other: Travel Grants. von Lilienfeld-Toal:Celgene, Oncopeptides: Consultancy, Honoraria. Straka:Celgene, Janssen, AMGEN: Consultancy, Research Funding, Speakers Bureau. Knop:Janssen, AMGEN, Bristol-Myers Squibb, Celgene: Consultancy, Honoraria.Lenalidomide, adriamycin, dexamethsone in newly diagnosed multiple myeloma
- Published
- 2019
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43. T(11;14) and High BCL2 Expression Are Predictive Biomarkers of Response to Venetoclax in Combination with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: Biomarker Analyses from the Phase 3 Bellini Study
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Harrison, Simon, Cavo, Michele, De La Rubia, Javier, Popat, Rakesh, Gasparetto, Cristina, Hungria, Vania T.M., Salwender, Hans, Suzuki, Kenshi, Kim, Inho, Moreau, Philippe, Spencer, Andrew, O'Dwyer, Michael E, Garg, Mamta, Punnoose, Elizabeth A, Jalaluddin, Muhammad, Jia, Jia, Yang, Xiaoqing, Sun, Yan, Ward, James E., Maciag, Paulo C., Ross, Jeremy A., and Kumar, Shaji K.
- Abstract
Harrison: GSK: Consultancy, Research Funding; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: investigator on studies, Research Funding; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen Cilag: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Cavo:celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accommodations, Speakers Bureau; sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; novartis: Honoraria; takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accommodations, Speakers Bureau; bms: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. De La Rubia:AMGEN: Consultancy; Takeda: Consultancy; AbbVie: Consultancy; Janssen: Consultancy; Celgene Corporation: Consultancy. Popat:Celgene Corporation: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel, accommodations, expenses; Janssen: Honoraria, Other: travel support to meetings; GSK: Consultancy, Honoraria; AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Other: travel, accommodations, expenses. Gasparetto:Janssen: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed ; BMS: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed ; Celgene: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed . Hungria:Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Consultancy, Honoraria, Speakers Bureau; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Consultancy, Honoraria, Speakers Bureau; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Salwender:Amgen: Honoraria, Other: Travel or accommodations; Bristol-Myers Squibb: Honoraria, Other: Travel or accommodations; Janssen Cilag: Honoraria, Other: Travel or accommodations; Sanofi: Honoraria, Other: Travel or accommodations; Celgene: Honoraria, Other: Travel or accommodations; AbbVie: Honoraria; Takeda: Honoraria, Other: Travel or accommodations. Suzuki:Ono: Research Funding; BMS: Honoraria, Research Funding; Takeda: Honoraria; Janssen: Honoraria; Celgene: Honoraria. Moreau:Celgene: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Takeda: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria. Spencer:AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Secura Bio: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Specialised Therapeutics Australia: Consultancy, Honoraria; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Servier: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Haemalogix: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen Oncology: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. O'Dwyer:Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Consultancy; GlycoMimetics Inc: Research Funding; BMS: Research Funding; Onkimmune: Equity Ownership, Membership on an entity's Board of Directors or advisory committees, Research Funding. Garg:Janssen: Honoraria; Novartis, Janssen: Research Funding; Janssen, Takeda, Novartis: Other: Travel expenses. Punnoose:Roche: Other: Stock/stock options; Genentech, Inc.: Employment. Jalaluddin:AbbVie: Employment, Other: Stock/stock options. Jia:AbbVie: Employment, Other: Stock/stock options. Yang:AbbVie: Employment, Other: Stock/stock options. Sun:AbbVie: Employment, Other: Stock/stock options. Ward:AbbVie: Employment, Other: Stock/stock options. Maciag:AbbVie: Employment, Other: Stock/stock options. Ross:AbbVie: Employment, Other: Stock/stock options. Kumar:Takeda: Research Funding; Celgene: Consultancy, Research Funding; Janssen: Consultancy, Research Funding.Venetoclax is a BCL-2 inhibitor that is FDA-approved in some indications. This presentation will focus on venetoclax for treatment of multiple myeloma, which is not an approved indication.
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- 2019
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44. Validation and Improvement Opportunities of the Revised International Staging System for Multiple Myeloma: An Analysis on Mature Data from European Clinical Trials within the Harmony Big Data Platform
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D'Agostino, Mattia, Waage, Anders, Lahuerta, Juan-José, Bertsch, Uta, Zamagni, Elena, Bullinger, Lars, Larocca, Alessandra, Mateos, Maria-Victoria, Van De Donk, Niels W. C. J., Salwender, Hans Jürgen, Bladé, Joan, van der Holt, Bronno, Tacchetti, Paola, Ciccone, Giovannino, Zweegman, Sonja, Goldschmidt, Hartmut, Cavo, Michele, San-Miguel, Jesús, Sonneveld, Pieter, Boccadoro, Mario, and Hernández-Rivas, Jesús María
- Abstract
Lahuerta: Takeda, Amgen, Celgene and Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees. Bertsch:Celgene: Other: travel support; Sanofi: Other: travel support. Zamagni:Celgene Corporation: Honoraria, Other: Advisory board, Speakers Bureau; Janssen: Honoraria, Other: Advisory board, Speakers Bureau; Amgen: Honoraria, Other: Advisory board, Speakers Bureau; BMS: Honoraria, Other: Advisory Board, Speakers Bureau; Takeda: Honoraria, Speakers Bureau; Sanofi: Honoraria, Other: Advisory Board, Speakers Bureau. Bullinger:Seattle Genetics: Honoraria; Janssen: Honoraria; Hexal: Honoraria; Gilead: Honoraria; Celgene: Honoraria; Daiichi Sankyo: Honoraria; Bristol-Myers Squibb: Honoraria; Bayer: Other: Financing of scientific research; Astellas: Honoraria; Amgen: Honoraria; Abbvie: Honoraria; Sanofi: Honoraria; Pfizer: Honoraria; Novartis: Honoraria; Menarini: Honoraria; Jazz Pharmaceuticals: Honoraria. Larocca:Amgen: Honoraria; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees. Mateos:Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Pharmamar: Membership on an entity's Board of Directors or advisory committees; Adaptive: Honoraria; EDO: Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees; GSK: Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees. Van De Donk:Roche: Membership on an entity's Board of Directors or advisory committees; Bayer: Membership on an entity's Board of Directors or advisory committees; Servier: Membership on an entity's Board of Directors or advisory committees; Celgene Corporation: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees; AMGEN: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees, Research Funding. Salwender:Janssen Cilag: Consultancy, Honoraria, Other: Travel grants; Celgene: Honoraria, Other: Travel grants; AMGEN: Honoraria, Other: Travel grants; Sanofi: Honoraria, Other: Travel grants; Bristol-Myers Squibb: Honoraria, Other: Travel grants; Takeda: Honoraria, Other: Travel grants; Oncopeptides: Honoraria, Other: Travel Grants. Bladé:Jansen, Celgene, Takeda, Amgen and Oncopeptides: Honoraria. Tacchetti:Janssen: Honoraria; BMS: Honoraria; Oncopeptides: Honoraria, Speakers Bureau; Celgene: Honoraria, Speakers Bureau; Takeda: Honoraria, Speakers Bureau; Amgen: Honoraria, Speakers Bureau. Zweegman:Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding. Goldschmidt:Chugai: Honoraria, Other: Grants and/or provision of Investigational Medicinal Product, Research Funding; Adaptive Biotechnology: Membership on an entity's Board of Directors or advisory committees; MSD: Research Funding; Dietmar-Hopp-Foundation: Other: Grants and/or provision of Investigational Medicinal Product; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Grants and/or provision of Investigational Medicinal Product, Research Funding; Molecular Partners: Research Funding; Novartis: Honoraria, Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other, Research Funding; ArtTempi: Honoraria; Amgen: Membership on an entity's Board of Directors or advisory committees, Other: Grants and/or provision of Investigational Medicinal Product, Research Funding; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Grants and/or provision of Investigational Medicinal Product, Research Funding; Sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Grants and/or provision of Investigational Medicinal Product, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Mundipharma: Research Funding; John Hopkins University: Other: Grants and/or provision of Investigational Medicinal Product. Cavo:bms: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; sanofi: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; novartis: Honoraria; takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accommodations, Speakers Bureau; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel accommodations, Speakers Bureau. San-Miguel:Amgen, Bristol-Myers Squibb, Celgene, Janssen, MSD, Novartis, Roche, Sanofi, and Takeda: Consultancy, Honoraria. Sonneveld:SkylineDx: Research Funding; Takeda: Honoraria, Research Funding; Karyopharm: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; BMS: Honoraria; Amgen: Honoraria, Research Funding. Boccadoro:Sanofi: Honoraria, Research Funding; Amgen: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria, Research Funding; AbbVie: Honoraria; Mundipharma: Research Funding; Celgene: Honoraria, Research Funding.This presentation includes discussion of off-label use of a drug or drugs for the treatment of multiple myeloma.
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- 2019
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45. Physical Function, Pain Severity, and Fatigue in Patients with Relapsed/Refractory Multiple Myeloma: Health-Related Quality of Life Results in Patients Receiving Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone
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Gasparetto, Cristina, Popat, Rakesh, Kumar, Shaji K., Cavo, Michele, de la Rubia, Javier, Hungria, Vania T.M., Salwender, Hans, Suzuki, Kenshi, Kim, Inho, Maciel, James, Hsiao, Liang-Tsai, Moreau, Philippe, Harrison, Simon, Jia, Jia, Karve, Sudeep, Ma, Esprit, Devine, Jacob, and Benjamin, Katy
- Abstract
Background:Despite treatment advances, multiple myeloma (MM) remains a condition with high unmet medical need as patients (pts) relapse and become resistant to therapy. MM pts experience a range of serious disease-related symptoms and side effects impacting their functioning and health-related quality of life (HRQL). The median overall survival (OS) has improved with the advent of new treatments in the last two decades, however, the impact of newer combination treatments on pt quality of life remains unknown (Beckner, N et al. Cancer Res. 2011;183:25; Bharat, N et al. J Clin Oncol2019;37:15(suppl):8039). Venetoclax is a novel, orally bioavailable small molecule inhibitor of BCL-2 activity in MM. In the Phase 3 double-blind, randomized clinical trial (M14-031, BELLINI) progression free survival (PFS) was studied in relapsed/refractory (RR) MM pts receiving venetoclax or placebo in combination with bortezomib and dexamethasone. In addition, patient-reported outcomes (PRO) data focused on physical functioning, pain, and fatigue from BELLINI were evaluated to better understand the overall impact on pt HRQL of adding venetoclax to bortezomib and dexamethasone-based doublet therapy.
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- 2019
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46. MCT1 As Molecularly Validated Predictive Marker for Lenalidomide-Maintenance Therapy in Multiple Myeloma
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Stroh, Jacob, Seckinger, Anja, Heider, Michael, Eichner, Ruth, Emde, Martina, Salwender, Hans, Bertsch, Uta, Goldschmidt, Hartmut, Weisel, Katja, Scheid, Christof, Hose, Dirk, and Bassermann, Florian
- Abstract
Introduction:
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- 2019
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47. T(11;14) and High BCL2Expression Are Predictive Biomarkers of Response to Venetoclax in Combination with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: Biomarker Analyses from the Phase 3 Bellini Study
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Harrison, Simon, Cavo, Michele, De La Rubia, Javier, Popat, Rakesh, Gasparetto, Cristina, Hungria, Vania T.M., Salwender, Hans, Suzuki, Kenshi, Kim, Inho, Moreau, Philippe, Spencer, Andrew, O'Dwyer, Michael E, Garg, Mamta, Punnoose, Elizabeth A, Jalaluddin, Muhammad, Jia, Jia, Yang, Xiaoqing, Sun, Yan, Ward, James E., Maciag, Paulo C., Ross, Jeremy A., and Kumar, Shaji K.
- Abstract
Background: Overexpression of the anti-apoptotic BCL-2 protein promotes multiple myeloma (MM) cell survival. Venetoclax (Ven) is a highly selective, potent, oral BCL-2 inhibitor that induces apoptosis and has shown synergistic activity with bortezomib (B) and dexamethasone (d). Phase 1 studies in relapsed/refractory (RR) MM demonstrated encouraging clinical efficacy of Ven + d in t(11;14) MM and in a broader patient (pt) population in combination with Bd. Recent results from the Phase 3 BELLINI study of Ven vs placebo (Pbo) + Bd in pts with RRMM demonstrated that pts treated with Ven + Bd had improved clinical response rates and progression-free survival (PFS) vs Pbo, although the overall survival (OS) result was in favor of Pbo. Subgroup analyses showed different efficacy and survival outcomes based on tumor cytogenetics and BCL-2 expression. Results of pre-specified subgroup analyses and additional retrospective correlative biomarker analyses in the Phase 3 BELLINI study are described herein.
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- 2019
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48. Treatment Response and Long-Term Survival in Multiple Myeloma in the GMMG-HD4 Trial - Neither Profit All Molecular Entities Alike, Nor Are Remissions to Different Regimen Equal
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Seckinger, Anja, Salwender, Hans Jürgen, Martin, Hans, Scheid, Christof, Hielscher, Thomas, Bertsch, Uta, Hummel, Manuela, Jauch, Anna, Knauf, Wolfgang, Emde, Martina, Beck, Susanne, Neben, Kai, Lokhorst, Henk M., van der Holt, Bronno, Duehrsen, Ulrich, Dürig, Jan, Lindemann, Hans-Walter, Schmidt-Wolf, Ingo, Haenel, Mathias, Lathan, Bernd, Raab, Marc S, Müller-Tidow, Carsten, Sonneveld, Pieter, Blau, Igor Wolfgang, Hillengass, Jens, Weisel, Katja, Goldschmidt, Hartmut, and Hose, Dirk
- Abstract
Seckinger: Celgene: Research Funding; Sanofi: Research Funding; EngMab: Research Funding. Salwender:Novartis: Honoraria, Other: travel suppport, Research Funding; Amgen: Honoraria, Other: travel suppport, Research Funding; Bristol-Myers Squibb: Honoraria, Other: travel suppport, Research Funding; Celgene: Honoraria, Other: travel suppport, Research Funding; Takeda: Honoraria; Janssen: Honoraria, Other: travel support, Research Funding. Scheid:Celgene: Honoraria; Janssen: Honoraria. Knauf:Janssen: Consultancy; AbbVie: Consultancy; Celgene: Consultancy, Honoraria; Gilead Sciences: Consultancy; Roche: Consultancy; Amgen: Consultancy, Honoraria; Mundipharma: Consultancy. Duehrsen:AbbVie: Consultancy, Honoraria; Amgen: Research Funding; Janssen: Honoraria; Celgene: Honoraria, Research Funding; Roche: Honoraria, Research Funding; Gilead: Consultancy, Honoraria. Dürig:Roche: Honoraria, Speakers Bureau; Janssen: Consultancy, Honoraria; Celgene: Honoraria. Schmidt-Wolf:Janssen: Research Funding; Novartis: Research Funding. Haenel:Novartis: Honoraria; Amgen: Honoraria; Roche: Honoraria; Takeda: Honoraria. Raab:Novartis: Consultancy, Honoraria, Research Funding; BMS: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Research Funding. Sonneveld:Janssen: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Amgen: Honoraria, Research Funding; Karyopharm: Honoraria, Research Funding; BMS: Honoraria, Research Funding. Blau:Celgene: Other: Advisory board, Research Funding; Janssen: Other: Advisory board, Research Funding; Amgen: Other: Advisory board; Takeda: Other: Advisory board; Novartis: Other: Advisory boards; BMS: Other: Advisory board. Hillengass:Takeda: Honoraria, Other: Advisory Board; BMS: Honoraria, Other: Advisory Board; Celgene: Consultancy, Honoraria, Other: Advisory Board, Research Funding; amgen: Consultancy, Honoraria, Other: Advisory Board; Sanofi: Research Funding; Janssen: Honoraria, Other: Advisory Board; Novartis: Honoraria, Other: Advisory Board. Weisel:Amgen, BMS, Celgene, Janssen, and Takeda: Honoraria; Amgen, Celgene, Janssen, and Sanofi: Research Funding; Amgen, BMS, Celgene, Janssen, Juno, Sanofi, and Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees. Goldschmidt:Chugai: Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Takeda: Consultancy, Research Funding; Sanofi: Consultancy, Research Funding; Mundipharma: Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Bristol Myers Squibb: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Research Funding; Adaptive Biotechnology: Consultancy; ArtTempi: Honoraria. Hose:Celgene: Honoraria, Research Funding; EngMab: Research Funding; Sanofi: Research Funding.
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- 2018
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49. Double Vs Single Autologous Stem Cell Transplantation for Newly Diagnosed Multiple Myeloma: Long-Term Follow-up (10-Years) Analysis of Randomized Phase 3 Studies
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Cavo, Michele, Goldschmidt, Hartmut, Rosinol, Laura, Pantani, Lucia, Zweegman, Sonja, Salwender, Hans Jürgen, Lahuerta, Juan Jose, Lokhorst, Henk M., Petrucci, Maria Teresa, Blau, Igor, Oriol, Albert, Testoni, Nicoletta, Weisel, Katja, Rios, Rafael, Patriarca, Francesca, Blanchard, Jesús, Dozza, Luca, Mateos, Maria-Victoria, Galli, Monica, San-Miguel, Jesus F, Boccadoro, Mario, Blade, Joan, and Sonneveld, Pieter
- Abstract
Cavo: GlaxoSmithKline: Honoraria, Membership on an entity's Board of Directors or advisory committees; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees; Adaptive Biotechnologies: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees. Goldschmidt:Celgene: Consultancy, Honoraria, Research Funding; Bristol Myers Squibb: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Research Funding; Adaptive Biotechnology: Consultancy; Sanofi: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; Chugai: Honoraria, Research Funding; Mundipharma: Research Funding; Novartis: Honoraria, Research Funding; ArtTempi: Honoraria; Janssen: Consultancy, Honoraria, Research Funding. Rosinol:Janssen, Celgene, Amgen, Takeda: Honoraria. Zweegman:Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene Corp.: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding. Salwender:Novartis: Honoraria, Other: travel suppport, Research Funding; Amgen: Honoraria, Other: travel suppport, Research Funding; Takeda: Honoraria; Bristol-Myers Squibb: Honoraria, Other: travel suppport, Research Funding; Janssen: Honoraria, Other: travel support, Research Funding; Celgene: Honoraria, Other: travel suppport, Research Funding. Lahuerta:Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees. Petrucci:Bristol-Myers Squibb: Honoraria, Other: Advisory Board; Takeda: Honoraria, Other: Advisory Board; Amgen: Honoraria, Other: Advisory Board; Celgene: Honoraria, Other: Advisory Board; Janssen-Cilag: Honoraria, Other: Advisory Board. Oriol:Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Weisel:Amgen, Celgene, Janssen, and Sanofi: Research Funding; Amgen, BMS, Celgene, Janssen, and Takeda: Honoraria; Amgen, BMS, Celgene, Janssen, Juno, Sanofi, and Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees. Rios:Amgen, Celgene, Janssen, and Takeda: Consultancy. Patriarca:Celgene: Other: Advisory Role; Travel, accommodations, expenses; Medac: Other: Travel, accommodations, expenses; Jazz: Other: Travel, accommodations, expenses; Janssen: Other: Advisory role; MSD Italy: Other: Advisory Role. Mateos:GSK: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; GSK: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Galli:Sigma-Tau: Honoraria; Celgene: Honoraria; Janssen: Honoraria; Bristol-Myers Squibb: Honoraria. San-Miguel:Novartis: Honoraria; Sanofi: Honoraria; Roche: Honoraria; BMS: Honoraria; Amgen: Honoraria; Janssen: Honoraria; Celgene: Honoraria. Boccadoro:Novartis: Honoraria, Research Funding; AbbVie: Honoraria; Janssen: Honoraria, Research Funding; Amgen: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Mundipharma: Research Funding; Sanofi: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria, Research Funding. Blade:Janssen: Honoraria; Celgene: Honoraria; Amgen: Honoraria. Sonneveld:Amgen: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Karyopharm: Honoraria, Research Funding; BMS: Honoraria, Research Funding.
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- 2018
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50. Quantitative Integrative Prediction of Survival Probability in Multiple Myeloma Using Molecular and Clinical Prognostic Factors in 657 Patients Treated with Bortezomib-Based Induction, High-Dose Therapy and Autologous Stem Cell Transplantation
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Hummel, Manuela, Hielscher, Thomas, Salwender, Hans Jürgen, Scheid, Christof, Martin, Hans, Bertsch, Uta, Goldschmidt, Hartmut, Seckinger, Anja, and Hose, Dirk
- Abstract
Salwender: Celgene: Honoraria, Other: travel suppport, Research Funding; Amgen: Honoraria, Other: travel suppport, Research Funding; Takeda: Honoraria; Novartis: Honoraria, Other: travel suppport, Research Funding; Bristol-Myers Squibb: Honoraria, Other: travel suppport, Research Funding; Janssen: Honoraria, Other: travel support, Research Funding. Scheid:Janssen: Honoraria; Celgene: Honoraria. Goldschmidt:ArtTempi: Honoraria; Chugai: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Takeda: Consultancy, Research Funding; Amgen: Consultancy, Research Funding; Mundipharma: Research Funding; Sanofi: Consultancy, Research Funding; Janssen: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Bristol Myers Squibb: Consultancy, Honoraria, Research Funding; Adaptive Biotechnology: Consultancy. Seckinger:Celgene: Research Funding; EngMab: Research Funding; Sanofi: Research Funding. Hose:EngMab: Research Funding; Celgene: Honoraria, Research Funding; Sanofi: Research Funding.
- Published
- 2018
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