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1. CD8+ CD28− regulatory T cells after induction therapy predict progression-free survival in myeloma patients: results from the GMMG-HD6 multicenter phase III study

Author

Kriegsmann, Katharina, Ton, Gigi Nu Hoang Quy, Awwad, Mohamed H. S., Benner, Axel, Bertsch, Uta, Besemer, Britta, Hänel, Mathias, Fenk, Roland, Munder, Markus, Dürig, Jan, Blau, Igor W., Huhn, Stefanie, Hose, Dirk, Jauch, Anna, 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, Seidel-Glätzer, Andrea, Weisel, Katja C., Salwender, Hans J., Müller-Tidow, Carsten, Raab, Marc S., Goldschmidt, Hartmut, Mai, Elias K., and Hundemer, Michael

Published
2024
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2. 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, and Goldschmidt, Hartmut

Published
2024
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3. Isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) in front-line treatment of high-risk multiple myeloma: interim analysis of the GMMG-CONCEPT trial

Author

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.

Published
2022
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4. 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, and Goldschmidt, Hartmut

Published
2021
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5. Selective elimination of immunosuppressive T cells in patients with multiple myeloma

Author

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

Published
2021
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6. CD8+CD28−regulatory T cells after induction therapy predict progression-free survival in myeloma patients: results from the GMMG-HD6 multicenter phase III study

Author

Kriegsmann, Katharina, Ton, Gigi Nu Hoang Quy, Awwad, Mohamed H. S., Benner, Axel, Bertsch, Uta, Besemer, Britta, Hänel, Mathias, Fenk, Roland, Munder, Markus, Dürig, Jan, Blau, Igor W., Huhn, Stefanie, Hose, Dirk, Jauch, Anna, 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, Seidel-Glätzer, Andrea, Weisel, Katja C., Salwender, Hans J., Müller-Tidow, Carsten, Raab, Marc S., Goldschmidt, Hartmut, Mai, Elias K., and Hundemer, Michael

Published
2024
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7. 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., primary, Hielscher, Thomas, additional, Bertsch, Uta, additional, Salwender, Hans J., additional, Zweegman, Sonja, additional, Raab, Marc S., additional, Munder, Markus, additional, Pantani, Lucia, additional, Mancuso, Katia, additional, Brossart, Peter, additional, Beksac, Meral, additional, Blau, Igor W., additional, Dürig, Jan, additional, Besemer, Britta, additional, Fenk, Roland, additional, Reimer, Peter, additional, van der Holt, Bronno, additional, Hänel, Mathias, additional, von Metzler, Ivana, additional, Graeven, Ullrich, additional, Müller-Tidow, Carsten, additional, Boccadoro, Mario, additional, Scheid, Christof, additional, Dimopoulos, Meletios A., additional, Hillengass, Jens, additional, Weisel, Katja C., additional, Cavo, Michele, additional, Sonneveld, Pieter, additional, and Goldschmidt, Hartmut, additional

Published
2023
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8. Functional and clinical characterization of the alternatively spliced isoform AML1-ETO9a in adult patients with translocation t(8;21)(q22;q22.1) acute myeloid leukemia (AML)

Author

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

Published
2020
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9. 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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10. Isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) in front-line treatment of high-risk multiple myeloma: interim analysis of the GMMG-CONCEPT trial

Author

Leypoldt, Lisa B., primary, Besemer, Britta, additional, Asemissen, Anne Marie, additional, Hänel, Mathias, additional, Blau, Igor Wolfgang, additional, Görner, Martin, additional, Ko, Yon-Dschun, additional, Reinhardt, Hans Christian, additional, Staib, Peter, additional, Mann, Christoph, additional, Lutz, Raphael, additional, Munder, Markus, additional, Graeven, Ullrich, additional, Peceny, Rudolf, additional, Salwender, Hans, additional, Jauch, Anna, additional, Zago, Manola, additional, Benner, Axel, additional, Tichy, Diana, additional, Bokemeyer, Carsten, additional, Goldschmidt, Hartmut, additional, and Weisel, Katja C., additional

Published
2021
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11. Functional and clinical characterization of the alternatively spliced isoform AML1-ETO9a in adult patients with translocation t(8;21)(q22;q22.1) acute myeloid leukemia (AML)

Author

Agrawal, Mridul, primary, Schwarz, Peggy, additional, Giaimo, Benedetto Daniele, additional, Bedzhov, Ivan, additional, Corbacioglu, Andrea, additional, Weber, Daniela, additional, Gaidzik, Verena I., additional, Jahn, Nikolaus, additional, Rücker, Frank G., additional, Schroeder, Thomas, additional, Kindler, Thomas, additional, Wattad, Mohammed, additional, Götze, Katharina, additional, Lübbert, Michael, additional, Salwender, Hans, additional, Ringhoffer, Mark, additional, Lange, Elisabeth, additional, Koller, Elisabeth, additional, Thol, Felicitas, additional, Heuser, Michael, additional, Ganser, Arnold, additional, Bullinger, Lars, additional, Paschka, Peter, additional, Döhner, Hartmut, additional, Geiger, Hartmut, additional, Borggrefe, Tilman, additional, Döhner, Konstanze, additional, and Oswald, Franz, additional

Published
2019
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12. Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE

Author

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.

Published
2021
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13. Publisher Correction: Bortezomib-based induction, high-dose melphalan and lenalidomide maintenance in myeloma up to 70 years of age

Author

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

Published
2024
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14. Bortezomib-based induction, high-dose melphalan and lenalidomide maintenance in myeloma up to 70 years of age

Author

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.

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

Author

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.

Published
2020
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16. 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)

Author

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

Published
2020
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