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1. Daratumumab, carfilzomib, and dexamethasone in relapsed or refractory myeloma: final analysis of PLEIADES and EQUULEUS

Author

Moreau, Philippe, Chari, Ajai, Oriol, Albert, Martinez-Lopez, Joaquin, Haenel, Mathias, Touzeau, Cyrille, Ailawadhi, Sikander, Besemer, Britta, de la Rubia Comos, Javier, Encinas, Cristina, Mateos, Maria-Victoria, Salwender, Hans, Rodriguez-Otero, Paula, Hulin, Cyrille, Karlin, Lionel, Sureda Balari, Anna, Bargay, Joan, Benboubker, Lotfi, Rosiñol, Laura, Tarantolo, Stefano, Terebelo, Howard, Yang, Shiyi, Wang, Jianping, Nnane, Ivo, Qi, Ming, Kosh, Michele, Delioukina, Maria, and Goldschmidt, Hartmut

Published
2023
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3. Molecular Long-Term Analysis of the GMMG-HD4 Trial in Multiple Myeloma—Patterns of Association of Chromosomal Aberrations with Response and Proliferation Determining Survival in Selecting Treatments in View of Limited Resources in Low- and Middle-Income Countries

Author

Seckinger, Anja, primary, Salwender, Hans, additional, Martin, Hans, additional, Scheid, Christof, additional, Hielscher, Thomas, additional, Bertsch, Uta, additional, Hummel, Manuela, additional, Jauch, Anna, additional, Knauf, Wolfgang, additional, Emde-Rajaratnam, Martina, additional, Beck, Susanne, additional, Neben, Kai, additional, Dührig, Jan, additional, Lindemann, Walter, additional, Schmidt-Wolf, Ingo G. H., additional, Hänel, Mathias, additional, Blau, Igor W., additional, Weisel, Katja, additional, Weinhold, Niels, additional, Raab, Marc S., additional, Goldschmidt, Hartmut, additional, Choon-Quinones, Mimi, additional, and Hose, Dirk, additional

Published
2024
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4. Midostaurin plus intensive chemotherapy for younger and older patients with AML and FLT3 internal tandem duplications

Author

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

Published
2022
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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

Author

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, Goldschmidt, Hartmut, 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.

Published
2024

7. RNA-sequencing based first choice of treatment and determination of risk in multiple myeloma

Author

Emde-Rajaratnam, Martina, primary, Beck, Susanne, additional, Benes, Vladimir, additional, Salwender, Hans, additional, Bertsch, Uta, additional, Scheid, Christoph, additional, Hänel, Mathias, additional, Weisel, Katja, additional, Hielscher, Thomas, additional, Raab, Marc S., additional, Goldschmidt, Hartmut, additional, Jauch, Anna, additional, Maes, Ken, additional, De Bruyne, Elke, additional, Menu, Eline, additional, De Veirman, Kim, additional, Moreaux, Jérôme, additional, Vanderkerken, Karin, additional, Seckinger, Anja, additional, and Hose, Dirk, additional

Published
2023
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8. Autologous-allogeneic versus autologous tandem stem cell transplantation and maintenance therapy with thalidomide for multiple myeloma patients over 60 years of age: a prospective phase II study

Author

Kröger, Nicolaus, primary, Wulf, Gerald, additional, Hegenbart, Ute, additional, Burchert, Andreas, additional, Stelljes, Matthias, additional, Gagelmann, Nico, additional, Brecht, Arne, additional, Kaufmann, Martin, additional, Müller, Lutz, additional, Ganser, Arnold, additional, Wolf, Dominik, additional, Bethge, Wolfgang, additional, Bornhäuser, Martin, additional, Kiehl, Michael, additional, Wagner, Eva-Maria, additional, Schmid, Christoph, additional, Reinhardt, Christian, additional, Kobbe, Guido, additional, Salwender, Hans, additional, Heinicke, Thomas, additional, Kropff, Martin, additional, Heinzelmann, Marion, additional, Ayuk, Francis, additional, Trümper, Lorenz, additional, Neubauer, Andreas, additional, Völp, Andreas, additional, Kluychnikov, Evgeny, additional, Schönland, Stefan, additional, and Wolschke, Christine, additional

Published
2023
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9. Midostaurin added to chemotherapy and continued single-agent maintenance therapy in acute myeloid leukemia with FLT3-ITD

Author

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

Published
2019
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10. Daratumumab, Bortezomib, and Dexamethasone for Treatment of Patients with Relapsed or Refractory Multiple Myeloma and Severe Renal Impairment: Results from the Phase 2 GMMG-DANTE Trial

Author

Leypoldt, Lisa B., primary, Gavriatopoulou, Maria, additional, Besemer, Britta, additional, Salwender, Hans, additional, Raab, Marc S., additional, Nogai, Axel, additional, Khandanpour, Cyrus, additional, Runde, Volker, additional, Jauch, Anna, additional, Zago, Manola, additional, Martus, Peter, additional, Goldschmidt, Hartmut, additional, Bokemeyer, Carsten, additional, Dimopoulos, Meletios A., additional, and Weisel, Katja C., additional

Published
2023
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11. S135: NEXT-GENERATION SEQUENCING-BASED MEASURABLE RESIDUAL DISEASE MONITORING IN ACUTE MYELOID LEUKEMIA WITH FLT3 INTERNAL TANDEM DUPLICATION TREATED WITH INTENSIVE CHEMOTHERAPY PLUS MIDOSTAURIN

Author

Rücker, Frank G, primary, Bullinger, Lars, additional, Cocciardi, Sibylle, additional, Skambraks, Sabrina, additional, Luck, Tamara J, additional, Weber, Daniela, additional, Schneider, Isabelle, additional, Corbacioglu, Andrea, additional, Gaidzik, Verena I, additional, Jahn, Ekaterina, additional, Jahn, Nikolaus, additional, Kapp-Schwoerer, Silke, additional, Schrade, Anika, additional, Theis, Frauke, additional, Fiedler, Walter, additional, Salih, Helmut R, additional, Wulf, Gerald, additional, Salwender, Hans, additional, Schroeder, Thomas, additional, Götze, Katharina S, additional, Kindler, Thomas, additional, Lübbert, Michael, additional, Schlenk, Richard F, additional, Thol, Felicitas, additional, Heuser, Michael, additional, Ganser, Arnold, additional, Döhner, Hartmut, additional, and Döhner, Konstanze, additional

Published
2023
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12. P947: TREATMENT PATTERNS AND OUTCOMES OF RE-INDUCTION THERAPIES PRIOR TO STEM CELL TRANSPLANTATION IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA TREATED IN CLINICAL PRACTICE IN GERMANY

Author

Sauer, Sandra, primary, Engelhardt, Monika, additional, Trautmann-Grill, Karolin, additional, Kimmich, Christoph, additional, Hänel, Mathias, additional, Schmidt-Hieber, Martin, additional, Salwender, Hans, additional, Flossmann, Carmen, additional, Heckmann, Hiltrud, additional, Ertel, Franziska, additional, Friederich, Andrea, additional, Patel, Sachin, additional, Piesch, Sabine, additional, Thun, Barbara, additional, and Raab, Marc S., additional

Published
2023
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13. Bortezomib-based induction therapy with high or low-dose dexamethasone in newly diagnosed, transplant-eligible multiple myeloma

Author

Mai, Elias K., Hielscher, Thomas, Bertsch, Uta, Schlenzka, Jana, Salwender, Hans J., Munder, Markus, Gerecke, Christian, Dührsen, Ulrich, Brossart, Peter, Neben, Kai, Hillengass, Jens, Raab, Marc S., Merz, Maximilian, Baertsch, Marc-Andrea, Jauch, Anna, Hose, Dirk, Martin, Hans, Lindemann, Hans-Walter, Blau, Igor W., Scheid, Christof, Weisel, Katja C., Goldschmidt, Hartmut, and for the German-speaking Myeloma Multicenter Group (GMMG)

Published
2019
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14. Comparison of IGLV2 ‐14 light chain sequences of patients with AL amyloidosis or multiple myeloma

Author

Berghaus, Natalie, primary, Schreiner, Sarah, additional, Poos, Alexandra M., additional, Raab, Marc S., additional, Goldschmidt, Hartmut, additional, Mai, Elias K., additional, Salwender, Hans‐Jürgen, additional, Bernhard, Helga, additional, Thurner, Lorenz, additional, Müller‐Tidow, Carsten, additional, Weinhold, Niels, additional, Hegenbart, Ute, additional, Schönland, Stefan O., additional, and Huhn, Stefanie, additional

Published
2023
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15. Daratumumab, carfilzomib, and dexamethasone in relapsed or refractory myeloma: final analysis of PLEIADES and EQUULEUS

Author

Janssen Research and Development, Moreau, Philippe, Chari, Ajai, Martínez-López, Joaquín, Haenel, Mathias, Touzeau, Cyrille, Ailawadhi, Sikander, Besemer, Britta, Rubia, Javier de la, Encinas, Cristina, Mateos, Maria Victoria, Salwender, Hans, Rodríguez-Otero, Paula, Hulin, Cyrille, Karlin, Lionel, Sureda, Anna, Bargay, Joan, Benboubker, Lotfi, Rosiñol, Laura, Tarantolo, Stefano, Terebelo, Howard, Yang, Shiyi, Wang, Jianping, Nnane, Ivo, Qi, Ming, Kosh, Michele, Delioukina, María, Goldschmidt, Hartmut, Janssen Research and Development, Moreau, Philippe, Chari, Ajai, Martínez-López, Joaquín, Haenel, Mathias, Touzeau, Cyrille, Ailawadhi, Sikander, Besemer, Britta, Rubia, Javier de la, Encinas, Cristina, Mateos, Maria Victoria, Salwender, Hans, Rodríguez-Otero, Paula, Hulin, Cyrille, Karlin, Lionel, Sureda, Anna, Bargay, Joan, Benboubker, Lotfi, Rosiñol, Laura, Tarantolo, Stefano, Terebelo, Howard, Yang, Shiyi, Wang, Jianping, Nnane, Ivo, Qi, Ming, Kosh, Michele, Delioukina, María, and Goldschmidt, Hartmut

Abstract

Daratumumab is approved in many countries as monotherapy and in combination regimens for relapsed/refractory multiple myeloma (RRMM) and newly diagnosed multiple myeloma [1,2,3]. Daratumumab-based combinations have also demonstrated encouraging efficacy in lenalidomide-refractory RRMM [4, 5]. Carfilzomib is approved as monotherapy and in combination regimens, including daratumumab and dexamethasone (D-Kd), for RRMM [6]. In the phase 3 CANDOR study, D-Kd (intravenous [IV] daratumumab; carfilzomib 56 mg/m2 twice weekly) improved progression-free survival (PFS) versus Kd in the overall population and lenalidomide-refractory patients [7, 8]. In the phase 3 A.R.R.O.W. study, once-weekly carfilzomib (70 mg/m2) significantly prolonged PFS versus twice-weekly carfilzomib (27 mg/m2), providing a safe and more convenient Kd dosing regimen [9].

Published
2023

16. Cystic transformation of focal lesions after therapy is associated with remission but adverse outcome in myeloma

Author

Merz, Maximilian, Hielscher, Thomas, Mai, Elias Karl, Seckinger, Anja, Hose, Dirk, Jauch, Anna, Sauer, Sandra, Luntz, Steffen, Bertsch, Uta, Raab, Marc S., Neben, Kai, Salwender, Hans, Blau, Igor W., Lindemann, Hans-Walter, Dürig, Jan, Scheid, Christof, Haenel, Mathias, Weisel, Katja, Weber, Tim, Delorme, Stefan, Goldschmidt, Hartmut, and Hillengass, Jens

Published
2019
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18. Rationale and design of the German-speaking myeloma multicenter group (GMMG) trial HD6: a randomized phase III trial on the effect of elotuzumab in VRD induction/consolidation and lenalidomide maintenance in patients with newly diagnosed myeloma

Author

Salwender, Hans, Bertsch, Uta, Weisel, Katja, Duerig, Jan, Kunz, Christina, Benner, Axel, Blau, Igor W., Raab, Marc Steffen, Hillengass, Jens, Hose, Dirk, Huhn, Stefanie, Hundemer, Michael, Andrulis, Mindaugas, Jauch, Anna, Seidel-Glaetzer, Andrea, Lindemann, Hans-Walter, Hensel, Manfred, Fronhoffs, Stefan, Martens, Uwe, Hansen, Timon, Wattad, Mohammed, Graeven, Ullrich, Munder, Markus, Fenk, Roland, Haenel, Mathias, Scheid, Christof, and Goldschmidt, Hartmut

Published
2019
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20. Comparison of bone marrow and peripheral blood aberrant plasma cell assessment by NGF in patients with MM

Author

Kriegsmann, Katharina, primary, Manta, Calin, additional, Schwab, Ricarda, additional, Mai, Elias K., additional, Raab, Marc S., additional, Salwender, Hans J., additional, Fenk, Roland, additional, Besemer, Britta, additional, Dürig, Jan, additional, Schroers, Roland, additional, von Metzler, Ivana, additional, Hänel, Mathias, additional, Mann, Christoph, additional, Asemissen, Anne M., additional, Heilmeier, Bernhard, additional, Bertsch, Uta, additional, Huhn, Stefanie, additional, Müller-Tidow, Carsten, additional, Goldschmidt, Hartmut, additional, and Hundemer, Michael, additional

Published
2023
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21. 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)

Author

Illerhaus, Gerald, primary, Ferreri, Andrés J.M., additional, Binder, Mascha, additional, Borchmann, Peter, additional, Hasenkamp, Justin, additional, Stilgenbauer, Stephan, additional, Roeth, Alexander, additional, Weber, Thomas, additional, Egerer, Gerlinde, additional, Ernst, Thomas, additional, Hertenstein, Bernd, additional, Lenz, Georg, additional, Kobbe, Guido, additional, Brunnberg, Uta, additional, Schmidt, Christian, additional, Kneba, Michael, additional, Dreyling, Martin, additional, Möhle, Robert, additional, Panse, Jens, additional, Heinicke, Thomas, additional, Schroll, Sebastian, additional, Larsen, Thomas S., additional, Salwender, Hans, additional, Naumann, Ralph, additional, Hess, Georg, additional, Thurner, Lorenz, additional, Pukrop, Tobias, additional, Keller, Ulrich, additional, Blystadt, Anne Kirsti, additional, Kroschinsky, Frank P., additional, Re, Francesca, additional, Pulczynski, Elisa, additional, Orsucci, Lorella, additional, Pospiech, Lisa, additional, Deckert, Martina, additional, Ponzoni, Maurilio, additional, Wendler, Julia, additional, Valk, Elke, additional, Calimeri, Teresa, additional, Kasenda, Benjamin, additional, Trepel, Martin, additional, Fricker, Heidi, additional, von Gottberg, Philipp, additional, Burger, Elvira, additional, Ihorst, Gabriele, additional, Grishina, Olga, additional, Hader, Claudia, additional, Zucca, Emanuele, additional, Finke, Jürgen, additional, and Schorb, Elisabeth, additional

Published
2022
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22. 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

Author

Straka, Christian, primary, Schaefer-Eckart, Kerstin, additional, Hertenstein, Bernd, additional, Bassermann, Florian, additional, Salwender, Hans, additional, Langer, Christian, additional, Krönke, Jan, additional, Kull, Miriam, additional, Schilling, Georgia, additional, Schieferdecker, Aneta, additional, Engelhardt, Monika, additional, Knop, Stefan, additional, Reusch, Julia, additional, Roesler, Wolf, additional, Metzner, Bernd, additional, Hebart, Holger, additional, Reichle, Albrecht, additional, Grube, Matthias, additional, Frickhofen, Norbert, additional, Gerecke, Christian, additional, Fuhrmann, Stephan, additional, Jung, Wolfram, additional, Gramatzki, Martin, additional, Decker, Thomas, additional, Dechow, Tobias, additional, Greiner, Jochen, additional, Brümmendorf, Tim H., additional, Ababei, Juliana, additional, Metzler, Ivana von, additional, Naumann, Ralph, additional, Fritz, Elisabeth, additional, Hentrich, Marcus, additional, Bojko, Peter, additional, Kubin, Thomas, additional, Schmidt, Christian, additional, Kaufmann, Martin, additional, Schmidt, Burkhard, additional, Hinke, Axel, additional, and Einsele, Hermann, additional

Published
2022
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23. Bone Marrow Immune Signatures in Multiple Myeloma Are Linked to Tumor Heterogeneity and Treatment Outcome

Author

Steiger, Simon, primary, Lutz, Raphael, additional, Prokoph, Nina, additional, Palit, Subarna, additional, Tirier, Stephan M, additional, Reichert, Philipp, additional, Baumann, Anja, additional, Hefner, Nadine, additional, Schumacher, Sabrina, additional, Vonficht, Dominik, additional, Grünschläger, Florian, additional, Poos, Alexandra M, additional, John, Lukas, additional, Haghverdi, Laleh, additional, Mallm, Jan-Philipp, additional, Mai, Elias K, additional, Friedrich, Mirco, additional, Kriegsmann, Katharina, additional, Awwad, Mohamed H.S., additional, Jauch, Anna, additional, Bertsch, Uta, additional, Tichy, Diana, additional, Müller-Tidow, Carsten, additional, Schroers, Roland, additional, Salwender, Hans, additional, Besemer, Britta, additional, Fenk, Roland, additional, Weisel, Katja, additional, Goldschmidt, Hartmut, additional, Huhn, Stefanie, additional, Hundemer, Michael, additional, Rippe, Karsten, additional, Haas, Simon, additional, Weinhold, Niels, additional, and Raab, Marc S, additional

Published
2022
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24. Implications and Prognostic Impact of Mass Spectrometry in Patients with Newly-Diagnosed Multiple Myeloma

Author

Mai, Elias K, primary, Huhn, Stefanie, additional, Miah, Kaya, additional, Poos, Alexandra M, additional, Scheid, Christof, additional, Weisel, Katja, additional, Bertsch, Uta, additional, Munder, Markus, additional, Berlanga, Oscar, additional, Hose, Dirk, additional, Seckinger, Anja, additional, Jauch, Anna, additional, Blau, Igor Wolfgang, additional, Haenel, Mathias, additional, Salwender, Hans, additional, Benner, Axel, additional, Raab, Marc S, additional, Goldschmidt, Hartmut, additional, and Weinhold, Niels, additional

Published
2022
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25. Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (Isa-KRd) in Patients with High-Risk Newly Diagnosed Multiple Myeloma: Planned Interim Analysis of the GMMG-Concept Trial

Author

Weisel, Katja, primary, Besemer, Britta, additional, Haenel, Mathias, additional, Lutz, Raphael, additional, Mann, Christoph, additional, Munder, Markus, additional, Goerner, Martin, additional, Reinhardt, Hans Christian, additional, Nogai, Axel, additional, Ko, Yon-Dschun, additional, De Wit, Maike, additional, Salwender, Hans, additional, Scheid, Christoph, additional, Graeven, Ullrich, additional, Peceny, Rudolf, additional, Staib, Peter, additional, Dieing, Annette, additional, Jauch, Anna, additional, Zago, Manola, additional, Benner, Axel, additional, Tichy, Diana, additional, Bokemeyer, Carsten, additional, Goldschmidt, Hartmut, additional, and Leypoldt, Lisa B., additional

Published
2022
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27. 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)

Author

Illerhaus, Gerald, Farreri, Andres J. M., Binder, Mascha, Borchmann, Peter, Hasenkamp, Justin, Stilgenbauer, Stephan, Roeth, Alexander, Webern, Thomas, Egerer, Gerlinde, Ernst, Thomas, Hertenstein, Bernd, Lenz, Georg, Kobbe, Guido, Brunnberg, Uta, Schmidt, Christian, Kneba, Michael, Dreyling, Martin, Moehle, 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, Juergen, Schorb, Elisabeth, Illerhaus, Gerald, Farreri, Andres J. M., Binder, Mascha, Borchmann, Peter, Hasenkamp, Justin, Stilgenbauer, Stephan, Roeth, Alexander, Webern, Thomas, Egerer, Gerlinde, Ernst, Thomas, Hertenstein, Bernd, Lenz, Georg, Kobbe, Guido, Brunnberg, Uta, Schmidt, Christian, Kneba, Michael, Dreyling, Martin, Moehle, 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, Juergen, and Schorb, Elisabeth

Published
2022

28. Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone (Isa-KRd) in Patients with High-Risk Newly Diagnosed Multiple Myeloma: Planned Interim Analysis of the GMMG-Concept Trial

Author

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, Leypoldt, Lisa B., 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.

Published
2022

29. Implications and Prognostic Impact of Mass Spectrometry in Patients with Newly-Diagnosed Multiple Myeloma

Author

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, Weinhold, Niels, 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

Published
2022

30. Second Revision of the International Staging System (R2-ISS) for Overall Survival in Multiple Myeloma:A European Myeloma Network (EMN) Report Within the HARMONY Project

Author

D'agostino, Mattia, Cairns, David A., Lahuerta, Juan José, Wester, Ruth, Bertsch, Uta, Waage, Anders, Zamagni, Elena, Mateos, María Victoria, Dall'olio, Daniele, Van De Donk, Niels W.C.J., Jackson, Graham, Rocchi, Serena, Salwender, Hans, Bladé Creixenti, Joan, Van Der Holt, Bronno, Castellani, Gastone, Bonello, Francesca, Capra, Andrea, Mai, Elias K., Dürig, Jan, Gay, Francesca, Zweegman, Sonja, Cavo, Michele, Kaiser, Martin F., Goldschmidt, Hartmut, Hernández Rivas, Jesús María, Larocca, Alessandra, Cook, Gordon, San-Miguel, Jesús F., Boccadoro, Mario, Sonneveld, Pieter, D'agostino, Mattia, Cairns, David A., Lahuerta, Juan José, Wester, Ruth, Bertsch, Uta, Waage, Anders, Zamagni, Elena, Mateos, María Victoria, Dall'olio, Daniele, Van De Donk, Niels W.C.J., Jackson, Graham, Rocchi, Serena, Salwender, Hans, Bladé Creixenti, Joan, Van Der Holt, Bronno, Castellani, Gastone, Bonello, Francesca, Capra, Andrea, Mai, Elias K., Dürig, Jan, Gay, Francesca, Zweegman, Sonja, Cavo, Michele, Kaiser, Martin F., Goldschmidt, Hartmut, Hernández Rivas, Jesús María, Larocca, Alessandra, Cook, Gordon, San-Miguel, Jesús F., Boccadoro, Mario, and Sonneveld, Pieter

Abstract

PURPOSEPatients with newly diagnosed multiple myeloma (NDMM) show heterogeneous outcomes, and approximately 60% of them are at intermediate-risk according to the Revised International Staging system (R-ISS), the standard-of-care risk stratification model. Moreover, chromosome 1q gain/amplification (1q+) recently proved to be a poor prognostic factor. In this study, we revised the R-ISS by analyzing the additive value of each single risk feature, including 1q+.PATIENTS AND METHODSThe European Myeloma Network, within the HARMONY project, collected individual data from 10,843 patients with NDMM enrolled in 16 clinical trials. An additive scoring system on the basis of top features predicting progression-free survival (PFS) and overall survival (OS) was developed and validated.RESULTSIn the training set (N = 7,072), at a median follow-up of 75 months, ISS, del(17p), lactate dehydrogenase, t(4;14), and 1q+ had the highest impact on PFS and OS. These variables were all simultaneously present in 2,226 patients. A value was assigned to each risk feature according to their OS impact (ISS-III 1.5, ISS-II 1, del(17p) 1, high lactate dehydrogenase 1, and 1q+ 0.5 points). Patients were stratified into four risk groups according to the total additive score: low (Second Revision of the International Staging System [R2-ISS]-I, 19.2%, 0 points), low-intermediate (II, 30.8%, 0.5-1 points), intermediate-high (III, 41.2%, 1.5-2.5 points), high (IV, 8.8%, 3-5 points). Median OS was not reached versus 109.2 versus 68.5 versus 37.9 months, and median PFS was 68 versus 45.5 versus 30.2 versus 19.9 months, respectively. The score was validated in an independent validation set (N = 3,771, of whom 1,214 were with complete data to calculate R2-ISS) maintaining its prognostic value.CONCLUSIONThe R2-ISS is a simple prognostic staging system allowing a better stratification of patients with intermediate-risk NDMM. The additive nature of this score fosters its future implementation with new pro

Published
2022

31. Testing G-CSF responsiveness predicts the individual susceptibility to infection and consecutive treatment in recipients of high-dose chemotherapy

Author

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

Published
2011
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32. 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

Author

Goldschmidt, Hartmut, primary, Mai, Elias K, additional, Nievergall, Eva, additional, Fenk, Roland, additional, Bertsch, Uta, additional, Tichy, Diana, additional, Besemer, Britta, additional, Dürig, Jan, additional, Schroers, Roland, additional, Metzler, Ivana v., additional, Haenel, Mathias, additional, Mann, Christoph, additional, Asemissen, Anne-Marie, additional, Heilmeier, Bernhard, additional, Huhn, Stefanie, additional, Kriegsmann, Katharina, additional, Weinhold, Niels, additional, Luntz, Steffen P., additional, Holderried, Tobias A. W., additional, Trautmann-Grill, Karolin, additional, Gezer, Deniz, additional, Klaiber-Hakimi, Maika, additional, Mueller, Martin, additional, Khandanpour, Cyrus, additional, Knauf, Wolfgang, additional, Munder, Markus, additional, Geer, Thomas, additional, Riesenberg, Hendrik, additional, Thomalla, Joerg, additional, Hoffmann, Martin, additional, Raab, Marc-Steffen, additional, Salwender, Hans, additional, and Weisel, Katja, additional

Published
2021
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33. 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

Author

Kumar, Shaji, primary, Harrison, Simon J, additional, Cavo, Michele, additional, de la Rubia, Javier, additional, Popat, Rakesh, additional, Gasparetto, Cristina J., additional, Hungria, Vania, additional, Salwender, Hans, additional, Suzuki, Kenshi, additional, Kim, Inho, additional, Onishi, Maika, additional, Ku, Grace, additional, Pothacamury, Rajvineeth Kumar, additional, Sehgal, Vasudha, additional, Masud, Abdullah A., additional, Ross, Jeremy A., additional, Dobkowska, Edyta, additional, and Moreau, Philippe, additional

Published
2021
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34. Midostaurin Plus Intensive Chemotherapy for Younger and Older Patients with Acute Myeloid Leukemia and FLT3 Internal Tandem Duplications

Author

Döhner, Hartmut, primary, Weber, Daniela, additional, Krzykalla, Julia, additional, Fiedler, Walter, additional, Wulf, Gerald, additional, Salih, Helmut R., additional, Lübbert, Michael, additional, Kühn, Michael W.M., additional, Schroeder, Thomas, additional, Salwender, Hans, additional, Götze, Katharina S., additional, Westermann, Jörg, additional, Fransecky, Lars, additional, Mayer, Karin, additional, Hertenstein, Bernd, additional, Ringhoffer, Mark, additional, Tischler, Hans-Joachim, additional, Machherndl-Spandl, Sigrid, additional, Schrade, Anika, additional, Paschka, Peter, additional, Gaidzik, Verena I, additional, Theis, Frauke, additional, Thol, Felicitas R, additional, Heuser, Michael, additional, Schlenk, Richard F., additional, Bullinger, Lars, additional, Saadati, Maral, additional, Benner, Axel, additional, Döhner, Konstanze, additional, and Ganser, Arnold, additional

Published
2021
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35. 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

Author

Mai, Elias K, primary, Hielscher, Thomas, additional, Bertsch, Uta, additional, Salwender, Hans, additional, Zweegman, Sonja, additional, Munder, Markus, additional, Pantani, Lucia, additional, Brossart, Peter, additional, Beksac, Meral, additional, Blau, Igor Wolfgang, additional, Raab, Marc-Steffen, additional, Dürig, Jan, additional, Giesen, Nicola, additional, Besemer, Britta, additional, Fenk, Roland, additional, Reimer, Peter, additional, van der Holt, Bronno, additional, Haenel, Mathias, additional, Metzler, Ivana v., additional, Graeven, Ullrich, additional, Boccadoro, Mario, additional, Scheid, Christof, additional, Dimopoulos, Meletios A., additional, Weisel, Katja, additional, Cavo, Michele, additional, Sonneveld, Pieter, additional, and Goldschmidt, Hartmut, additional

Published
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

Author

Goldschmidt, Hartmut, primary, Mai, Elias K, additional, Bertsch, Uta, additional, Besemer, Britta, additional, Haenel, Mathias, additional, Miah, Kaya, additional, Fenk, Roland, additional, Schlenzka, Jana, additional, Munder, Markus, additional, Dürig, Jan, additional, Blau, Igor Wolfgang, additional, Huhn, Stefanie, additional, Hose, Dirk, additional, Jauch, Anna, additional, Kunz, Christina, additional, Neubauer, Andreas, additional, Scheid, Christof, additional, Schroers, Roland, additional, Metzler, Ivana v., additional, Schieferdecker, Aneta, additional, Thomalla, Joerg, additional, Reimer, Peter, additional, Mahlberg, Rolf, additional, Graeven, Ullrich, additional, Kremers, Stephan, additional, Martens, Uwe M., additional, Kunz, Christian, additional, Hensel, Manfred, additional, Seidel-Glaetzer, Andrea, additional, Weisel, Katja, additional, Raab, Marc-Steffen, additional, and Salwender, Hans, additional

Published
2021
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37. Chromosome 1q21 abnormalities refine outcome prediction in patients with multiple myeloma - a meta-analysis of 2,596 trial patients

Author

Weinhold, Niels, primary, Salwender, Hans J., additional, Cairns, David A., additional, Raab, Marc S., additional, Waldron, George, additional, Blau, Igor W., additional, Bertsch, Uta, additional, Hielscher, Thomas, additional, Morgan, Gareth J., additional, Jauch, Anna, additional, Davies, Faith E., additional, Hänel, Mathias, additional, Cook, Gordon, additional, Scheid, Christoph, additional, Houlston, Richard, additional, Goldschmidt, Hartmut, additional, Jackson, Graham, additional, and Kaiser, Martin F., additional

Published
2021
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38. Predictive factors for severe infections and early death during novel agent-based induction therapy in newly diagnosed, transplant-eligible myeloma : a multicohort analysis from phase III trials

Author

Mai, Elias, Hielscher, Thomas, Bertsch, Uta, Salwender, Hans J., Munder, Markus, Brossart, Peter, Blau, Igor W., Raab, Marc, Dürig, Jan, Giesen, Nicola, Besemer, Britta, Fenk, Roland, Wattad, Mohammed, Haenel, Mathias, von Metzler, Ivana, Graeven, Ullrich, Scheid, Christoph, Weisel, Katja, and Goldschmidt, Hartmut

Subjects
Medizin, ComputingMethodologies_GENERAL
Abstract

Poster-Abstract

Published
2021

39. Lenalidomide versus bortezomib maintenance after frontline autologous stem cell transplantation for multiple myeloma

Author

Baertsch, Marc-Andrea, Mai, Elias K., Hielscher, Thomas, Bertsch, Uta, Salwender, Hans J., Munder, Markus, Fuhrmann, Stephan, Duehrsen, Ulrich, Brossart, Peter, Neben, Kai, Schlenzka, Jana, Kunz, Christina, Raab, Marc S., Hillengass, Jens, Jauch, Anna, Seckinger, Anja, Hose, Dirk, Luntz, Steffen, Sonneveld, Pieter, Lokhorst, Henk, Martin, Hans, Goerner, Martin, Hoffmann, Martin, Lindemann, Hans-Walter, Bernhard, Helga, Blau, Igor W., Scheid, Christof, Besemer, Britta, Weisel, Katja C., Haenel, Mathias, Duerig, Jan, Goldschmidt, Hartmut, Baertsch, Marc-Andrea, Mai, Elias K., Hielscher, Thomas, Bertsch, Uta, Salwender, Hans J., Munder, Markus, Fuhrmann, Stephan, Duehrsen, Ulrich, Brossart, Peter, Neben, Kai, Schlenzka, Jana, Kunz, Christina, Raab, Marc S., Hillengass, Jens, Jauch, Anna, Seckinger, Anja, Hose, Dirk, Luntz, Steffen, Sonneveld, Pieter, Lokhorst, Henk, Martin, Hans, Goerner, Martin, Hoffmann, Martin, Lindemann, Hans-Walter, Bernhard, Helga, Blau, Igor W., Scheid, Christof, Besemer, Britta, Weisel, Katja C., Haenel, Mathias, Duerig, Jan, and Goldschmidt, Hartmut

Abstract

Lenalidomide (LEN) maintenance (MT) post autologous stem cell transplantation (ASCT) is standard of care in newly diagnosed multiple myeloma (MM) but has not been compared to other agents in clinical trials. We retrospectively compared bortezomib (BTZ; n=138) or LEN (n=183) MT from two subsequent GMMG phase III trials. All patients received three cycles of BTZ-based triplet induction and post-ASCT MT. BTZ MT (1.3mg/m(2) i.v.) was administered every 2 weeks for 2 years. LEN MT included two consolidation cycles (25mg p.o., days 1-21 of 28 day cycles) followed by 10-15mg/day for 2 years. The BTZ cohort more frequently received tandem ASCT (91% vs. 33%) due to different tandem ASCT strategies. In the LEN and BTZ cohort, 43% and 46% of patients completed 2 years of MT as intended (p=0.57). Progression-free survival (PFS; HR=0.83, p=0.18) and overall survival (OS; HR=0.70, p=0.15) did not differ significantly with LEN vs. BTZ MT. Patients with

Published
2021

40. Chromosome 1q21 abnormalities refine outcome prediction in patients with multiple myeloma - a meta-analysis of 2,596 trial patients

Author

Weinhold, Niels, Salwender, Hans J., Cairns, David A., Raab, Marc S., Waldron, George, Blau, Igor W., Bertsch, Uta, Hielscher, Thomas, Morgan, Gareth J., Jauch, Anna, Davies, Faith E., Hanel, Mathias, Cook, Gordon, Scheid, Christoph, Houlston, Richard, Goldschmidt, Hartmut, Jackson, Graham, Kaiser, Martin F., Weinhold, Niels, Salwender, Hans J., Cairns, David A., Raab, Marc S., Waldron, George, Blau, Igor W., Bertsch, Uta, Hielscher, Thomas, Morgan, Gareth J., Jauch, Anna, Davies, Faith E., Hanel, Mathias, Cook, Gordon, Scheid, Christoph, Houlston, Richard, Goldschmidt, Hartmut, Jackson, Graham, and Kaiser, Martin F.

Published
2021

41. 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

Author

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, Goldschmidt, Hartmut, 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

Published
2021

42. Prognostic Impact of Serum Free Light Chain Ratio Normalization in Patients with Multiple Myeloma Treated within the GMMG-MM5 Trial

Author

Klein, Eva-Maria, Tichy, Diana, Salwender, Hans J., Mai, Elias K., Duerig, Jan, Weisel, Katja C., Benner, Axel, Bertsch, Uta, Akhavanpoor, Mabast, Besemer, Britta, Munder, Markus, Lindemann, Hans-Walter, Hose, Dirk, Seckinger, Anja, Luntz, Steffen, Jauch, Anna, Elmaagacli, Ahmet, Fuhrmann, Stephan, Brossart, Peter, Goerner, Martin, Bernhard, Helga, Raab, Marc S., Blau, Igor W., Haenel, Mathias, Scheid, Christof, Goldschmidt, Hartmut, Klein, Eva-Maria, Tichy, Diana, Salwender, Hans J., Mai, Elias K., Duerig, Jan, Weisel, Katja C., Benner, Axel, Bertsch, Uta, Akhavanpoor, Mabast, Besemer, Britta, Munder, Markus, Lindemann, Hans-Walter, Hose, Dirk, Seckinger, Anja, Luntz, Steffen, Jauch, Anna, Elmaagacli, Ahmet, Fuhrmann, Stephan, Brossart, Peter, Goerner, Martin, Bernhard, Helga, Raab, Marc S., Blau, Igor W., Haenel, Mathias, Scheid, Christof, and Goldschmidt, Hartmut

Abstract

Simple Summary For multiple myeloma (MM) patients with measurable disease, there is no recommendation to monitor serum free light chains during therapy. However, this could provide important information in terms of prognosis. We investigated the prognostic impact of serum free light chain ratio (FLCr) normalization in 590 patients with secretory MM during first-line treatment within the German-Speaking Myeloma Multicenter Group MM5 trial. We are able to show that there is an increasing percentage of patients who achieve FLCr normalization during therapy. Importantly, we demonstrate that FLCr normalization at any time before the start of maintenance is significantly associated with prolonged progression-free and overall survival in multivariable time-dependent Cox regression analyses. This suggests that FLCr normalization during therapy is an important and simple way to assess prognostic factor in MM and supports the serial measurement of serum free light chains during therapy, even in patients with secretory MM. We investigated the prognostic impact of time-dependent serum free light chain ratio (FLCr) normalization in 590 patients with secretory multiple myeloma (MM) during first-line treatment within the German-Speaking Myeloma Multicenter Group MM5 trial. Serum free light chains (sFLC) were assessed by the Freelite test at baseline, after induction, mobilization, autologous blood stem cell transplantation, consolidation and every three months during maintenance or follow up within two years after the start of maintenance. The proportion of patients with a normal or normalized FLCr increased from 3.6% at baseline to 23.2% after induction and 64.7% after consolidation. The achievement of FLCr normalization at any one time before the start of maintenance was associated with significantly prolonged progression-free survival (PFS) (p < 0.01, hazard ratio (HR) = 0.61, 95% confidence interval (95% CI) = 0.47-0.79) and overall survival (OS) (p = 0.02, HR = 0.67, 95% CI =

Published
2021

43. Kinetics of renal function during induction in newly diagnosed multiple myeloma: results of two prospective studies by the German Myeloma Study Group DSMM

Author

Bachmann, Friederike, Schreder, Martin, Engelhardt, Monika, Langer, Christian, Wolleschak, Denise, Mügge, Lars-Olof, Dürk, Heinz, Schäfer-Eckart, Kerstin, Blau, Igor-Wolfgang, Gramatzki, Martin, Liebisch, Peter, Grube, Matthias, Metzler, Ivana von, Bassermann, Florian, Metzner, Bernd, Röllig, Christoph, Hertenstein, Bernd, Khandanpour, Cyrus, Dechow, Tobias, Hebart, Holger, Jung, Wolfram, Theurich, Sebastian, Maschmeyer, Georg, Salwender, Hans, Hess, Georg, Bittrich, Max, Rasche, Leo, Brioli, Annamaria, Eckardt, Kai-Uwe, Straka, Christian, Held, Swantje, Einsele, Hermann, Knop, Stefan, Bachmann, Friederike, Schreder, Martin, Engelhardt, Monika, Langer, Christian, Wolleschak, Denise, Mügge, Lars-Olof, Dürk, Heinz, Schäfer-Eckart, Kerstin, Blau, Igor-Wolfgang, Gramatzki, Martin, Liebisch, Peter, Grube, Matthias, Metzler, Ivana von, Bassermann, Florian, Metzner, Bernd, Röllig, Christoph, Hertenstein, Bernd, Khandanpour, Cyrus, Dechow, Tobias, Hebart, Holger, Jung, Wolfram, Theurich, Sebastian, Maschmeyer, Georg, Salwender, Hans, Hess, Georg, Bittrich, Max, Rasche, Leo, Brioli, Annamaria, Eckardt, Kai-Uwe, Straka, Christian, Held, Swantje, Einsele, Hermann, and Knop, Stefan

Abstract

Simple Summary: Renal insufficiency is frequently seen in newly diagnosed multiple myeloma and can be due to the disease itself but also caused by medical interventions or infections. Patients with severe renal insufficiency are known to have an adverse prognosis, but recently, it was shown that even moderately impaired kidney function can have long-term sequelae. Achieving quick disease control by effective antimyeloma therapy can lead to the recovery of renal function. We investigated the kidney-specific variables in a large cohort of 770 myeloma patients receiving three different three-drug regimens for initial myeloma treatment to learn more about the differential effects on kidney function in an early disease phase. All regimens had a positive impact on kidney function without a difference in the proportion of patients who reached normal renal function after three cycles. Interestingly, patients who received bortezomib, lenalidomide, and dexamethasone tended to have higher risk for a worse renal function following induction when compared to the initial values. Abstract: Background: Preservation of kidney function in newly diagnosed (ND) multiple myeloma (MM) helps to prevent excess toxicity. Patients (pts) from two prospective trials were analyzed, provided postinduction (PInd) restaging was performed. Pts received three cycles with bortezomib (btz), cyclophosphamide, and dexamethasone (dex; VCD) or btz, lenalidomide (len), and dex (VRd) or len, adriamycin, and dex (RAD). The minimum required estimated glomerular filtration rate (eGFR) was >30 mL/min. We analyzed the percent change of the renal function using the International Myeloma Working Group (IMWG) criteria and Kidney Disease: Improving Global Outcomes (KDIGO)-defined categories. Results: Seven hundred and seventy-two patients were eligible. Three hundred and fifty-six received VCD, 214 VRd, and 202 RAD. VCD patients had the best baseline eGFR. The proportion of pts with eGFR <45 mL/min decreased from 7.

Published
2021

44. Lenalidomide versus bortezomib maintenance after frontline autologous stem cell transplantation for multiple myeloma

Author

German-Speaking Myeloma Multicenter Group (GMMG), Bärtsch, Marc-Andrea, Mai, Elias K., Hielscher, Thomas, Bertsch, Uta, Salwender, Hans J., Munder, Markus, Fuhrmann, Stephan, Dührsen, Ulrich, Brossart, Peter, Neben, Kai, Schlenzka, Jana, Kunz, Christina, Raab, Marc-Steffen, Hillengaß, Jens, Jauch, Anna, Seckinger, Anja, Hose, Dirk, Luntz, Steffen, Sonneveld, Pieter, Lokhorst, Henk, Martin, Hans, Görner, Martin, Hoffmann, Martin, Lindemann, Hans-Walter, Bernhard, Helga, Blau, Igor-Wolfgang, Scheid, Christof, Besemer, Britta, Weisel, Katja C., Hänel, Mathias, Dürig, Jan, Goldschmidt, Hartmut, German-Speaking Myeloma Multicenter Group (GMMG), Bärtsch, Marc-Andrea, Mai, Elias K., Hielscher, Thomas, Bertsch, Uta, Salwender, Hans J., Munder, Markus, Fuhrmann, Stephan, Dührsen, Ulrich, Brossart, Peter, Neben, Kai, Schlenzka, Jana, Kunz, Christina, Raab, Marc-Steffen, Hillengaß, Jens, Jauch, Anna, Seckinger, Anja, Hose, Dirk, Luntz, Steffen, Sonneveld, Pieter, Lokhorst, Henk, Martin, Hans, Görner, Martin, Hoffmann, Martin, Lindemann, Hans-Walter, Bernhard, Helga, Blau, Igor-Wolfgang, Scheid, Christof, Besemer, Britta, Weisel, Katja C., Hänel, Mathias, Dürig, Jan, and Goldschmidt, Hartmut

Abstract

Lenalidomide (LEN) maintenance (MT) post autologous stem cell transplantation (ASCT) is standard of care in newly diagnosed multiple myeloma (MM) but has not been compared to other agents in clinical trials. We retrospectively compared bortezomib (BTZ; n = 138) or LEN (n = 183) MT from two subsequent GMMG phase III trials. All patients received three cycles of BTZ-based triplet induction and post-ASCT MT. BTZ MT (1.3 mg/m2 i.v.) was administered every 2 weeks for 2 years. LEN MT included two consolidation cycles (25 mg p.o., days 1–21 of 28 day cycles) followed by 10–15 mg/day for 2 years. The BTZ cohort more frequently received tandem ASCT (91% vs. 33%) due to different tandem ASCT strategies. In the LEN and BTZ cohort, 43% and 46% of patients completed 2 years of MT as intended (p = 0.57). Progression-free survival (PFS; HR = 0.83, p = 0.18) and overall survival (OS; HR = 0.70, p = 0.15) did not differ significantly with LEN vs. BTZ MT. Patients with

Published
2021

45. Treatment with Thalidomide and Cyclophosphamide (TCID) is Superior to Vincristine (VID) and to Vinorelbine (VRID) Regimens in Patients with Refractory or Recurrent Multiple Myeloma

Author

Auel, Britta, Goldschmidt, Hartmut, Geer, Thomas, Moehler, Thomas M., Platzbecker, Uwe, Naumann, Ralph, Blau, Igor, Hänel, Mathias, Knauf, Wolfgang, Nückel, Holger, Salwender, Hans-Jürgen, Scheid, Christof, Weisel, Katja, Gorschlüter, Marcus, Glasmacher, Axel, Schmidt-Wolf, Ingo G. H., and The German Refractory Myeloma Study Group

Published
2012
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46. 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

Author

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

Published
2020
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47. Kinetics of Renal Function during Induction in Newly Diagnosed Multiple Myeloma: Results of Two Prospective Studies by the German Myeloma Study Group DSMM

Author

Bachmann, Friederike, primary, Schreder, Martin, additional, Engelhardt, Monika, additional, Langer, Christian, additional, Wolleschak, Denise, additional, Mügge, Lars Olof, additional, Dürk, Heinz, additional, Schäfer-Eckart, Kerstin, additional, Blau, Igor Wolfgang, additional, Gramatzki, Martin, additional, Liebisch, Peter, additional, Grube, Matthias, additional, v Metzler, Ivana, additional, Bassermann, Florian, additional, Metzner, Bernd, additional, Röllig, Christoph, additional, Hertenstein, Bernd, additional, Khandanpour, Cyrus, additional, Dechow, Tobias, additional, Hebart, Holger, additional, Jung, Wolfram, additional, Theurich, Sebastian, additional, Maschmeyer, Georg, additional, Salwender, Hans, additional, Hess, Georg, additional, Bittrich, Max, additional, Rasche, Leo, additional, Brioli, Annamaria, additional, Eckardt, Kai-Uwe, additional, Straka, Christian, additional, Held, Swantje, additional, Einsele, Hermann, additional, and Knop, Stefan, additional

Published
2021
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48. Front-line daratumumab-VTd versus standard-of-care in ASCT-eligible multiple myeloma: matching-adjusted indirect comparison

Author

Moreau, Philippe, primary, Hebraud, Benjamin, additional, Facon, Thierry, additional, Leleu, Xavier, additional, Hulin, Cyrille, additional, Hashim, Mahmoud, additional, Hu, Yannan, additional, Caillot, Denis, additional, Benboubker, Lofti, additional, Zweegman, Sonja, additional, Merz, Maximilian, additional, Weisel, Katja, additional, Salwender, Hans, additional, Mai, Elias K, additional, Goldschmidt, Hartmut, additional, Bertsch, Uta, additional, Vanquickelberghe, Véronique, additional, Kampfenkel, Tobias, additional, Boer, Carla de, additional, Krotneva, Stanimira, additional, Proskorovsky, Irina, additional, He, Jianming, additional, Lam, Annette, additional, Lee, Charlene, additional, Cote, Sarah, additional, and Sonneveld, Pieter, additional

Published
2021
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49. Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial

Author

Goldschmidt, Hartmut, Mai, Elias K., Duerig, Jan, Scheid, Christof, Weisel, Katja C., Kunz, Christina, Bertsch, Uta, Hielscher, Thomas, Merz, Maximilian, Munder, Markus, Lindemann, Hans-Walter, Huegle-Doerr, 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., Haenel, Mathias, Salwender, Hans J., Goldschmidt, Hartmut, Mai, Elias K., Duerig, Jan, Scheid, Christof, Weisel, Katja C., Kunz, Christina, Bertsch, Uta, Hielscher, Thomas, Merz, Maximilian, Munder, Markus, Lindemann, Hans-Walter, Huegle-Doerr, 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., Haenel, 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.

Published
2020

50. Autologous stem cell transplantation in multiple myeloma patients: utilization patterns and hospital effects

Author

Jansen, Lina, Merz, Maximilian, Engelhardt, Monika, Weisel, Katja, Scheid, Christof, Straka, Christian, Langer, Christian, Salwender, Hans, Einsele, Hermann, Kroege, Nikolaus, Beelen, Dietrich W., Dreger, Peter, Goldschmidt, Hartmut, Brenner, Hermann, Jansen, Lina, Merz, Maximilian, Engelhardt, Monika, Weisel, Katja, Scheid, Christof, Straka, Christian, Langer, Christian, Salwender, Hans, Einsele, Hermann, Kroege, Nikolaus, Beelen, Dietrich W., Dreger, Peter, Goldschmidt, Hartmut, and Brenner, Hermann

Abstract

Evidence on volume outcome associations for autologous stem cell transplantation (ASCT) in multiple myeloma (MM) is limited. We investigated ASCT utilization patterns and volume outcome associations in the German National Registry for Stem Cell Transplants (DRST). MM patients with an upfront ASCT between 1998 and 2014 registered in the DRST were included. ASCT utilization increased strongly from 6% to 17% between 1999 and 2013 with the largest increase for patients aged 60-64 years (8-34%). The mean number of ASCTs conducted in the hospitals per year varied (quintiles, Q1:0.0-8.2 to Q5:31.0-102.7). Center volume was not associated with survival after upfront ASCT (lowest vs. highest center volume, hazard ratios and 95% confidence intervals: 0.95 (0.76-1.18),p = 0.92). Our findings may reflect a high standard of care and degree of specialization of centers performing ASCT for MM in Germany.

Published
2020

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