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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

Author

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, Zirpel, Iris, 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, and Salwender, Hans J

Published
2024
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3. Elotuzumab, lenalidomide, bortezomib, dexamethasone, and autologous haematopoietic stem-cell transplantation for newly diagnosed multiple myeloma (GMMG-HD6): results from a randomised, phase 3 trial

Author

Mai, Elias K, primary, Goldschmid, Hartmut, additional, Miah, Kaya, additional, Bertsch, Uta, additional, Besemer, Britta, additional, Hänel, Mathias, additional, Krzykalla, Julia, additional, Fenk, Roland, additional, Schlenzka, Jana, additional, Munder, Markus, additional, Dürig, Jan, additional, Blau, Igor W, additional, Huhn, Stefanie, additional, Hose, Dirk, additional, Jauch, Anna, additional, Kunz, Christina, additional, Mann, Christoph, additional, Weinhold, Niels, additional, Scheid, Christof, additional, Schroers, Roland, additional, von Metzler, Ivana, additional, Schieferdecker, Aneta, additional, Thomalla, Jörg, additional, Reimer, Peter, additional, Mahlberg, Rolf, additional, Graeven, Ullrich, additional, Kremers, Stephan, additional, Martens, Uwe M, additional, Kunz, Christian, additional, Hensel, Manfred, additional, Benner, Axel, additional, Seidel-Glätzer, Andrea, additional, Weisel, Katja C, additional, Raab, Marc S, additional, Salwender, Hans J, additional, Adrian, Nicole, additional, Bernhard, Helga, additional, Böck, Hans-Peter, additional, Bolling, Claus, additional, Dingeldein, Gerrit, additional, Emde, Till-Oliver, additional, Ferstl, Barbara, additional, Fietz, Thomas, additional, Fronhoffs, Stefan, additional, Fuhrmann, Stephan, additional, Fuxius, Stefan, additional, Geer, Thomas, additional, Görner, Martin, additional, Guenther, Barbara, additional, Hartmann, Frank, additional, Heilmeier, Bernhard, additional, Heinsch, Michael, additional, Hoffmann, Martin, additional, Holderried, Tobias A.W., additional, Klein, Stefan, additional, Klump, Martin, additional, Knauf, Wolfgang, additional, La Rosée, Paul, additional, Lange, Elisabeth, additional, Lindemann, Walter, additional, Lopez, Roderico, additional, Mayer, Frank, additional, Nückel, Holger, additional, Papesch, Eva, additional, Procaccianti, Maria, additional, Reichart, Alexander, additional, Rummel, Mathias, additional, Scheuer, Lars, additional, Schmitt, Hans-Roland, additional, Staib, Peter, additional, Steiniger, Heike, additional, Tischler, Hans-Joachim, additional, Ulshöfer, Thomas, additional, Verbeek, Walter, additional, Wacker, Alexander, additional, and Zirpel, Iris, additional

Published
2024
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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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6. Impact of novel agent therapies on immune cell subsets and infectious complications in patients with relapsed/refractory multiple myeloma

Author

John, Lukas, primary, Miah, Kaya, additional, Benner, Axel, additional, Mai, Elias K., additional, Kriegsmann, Katharina, additional, Hundemer, Michael, additional, Kaudewitz, Dorothee, additional, Müller-Tidow, Carsten, additional, Jordan, Karin, additional, Goldschmidt, Hartmut, additional, Raab, Marc S., additional, and Giesen, Nicola, additional

Published
2023
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7. A phase 2 clinical trial of combined BRAF/MEK inhibition for BRAFV600E-mutated multiple myeloma

Author

Giesen, Nicola, primary, Chatterjee, Manik, additional, Scheid, Christof, additional, Poos, Alexandra M., additional, Besemer, Britta, additional, Miah, Kaya, additional, Benner, Axel, additional, Becker, Nicole, additional, Moehler, Thomas, additional, Metzler, Ivana, additional, Khandanpour, Cyrus, additional, Seidel-Glaetzer, Andrea, additional, Trautmann-Grill, Karolin, additional, Kortüm, K. Martin, additional, Müller-Tidow, Carsten, additional, Mechtersheimer, Gunhild, additional, Goeppert, Benjamin, additional, Stenzinger, Albrecht, additional, Weinhold, Niels, additional, Goldschmidt, Hartmut, additional, Weisel, Katja, additional, and Raab, Marc S., additional

Published
2023
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8. 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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10. 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

11. 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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12. Impact of Novel Therapies on CD4-T-Cell-Numbers and Infectious Complications in Patients with Relapsed/Refractory Multiple Myeloma

Author

John, Lukas, primary, Miah, Kaya, additional, Benner, Axel, additional, Mai, Elias K, additional, Kriegsmann, Katharina, additional, Hundemer, Michael, additional, Mueller-Tidow, Carsten, additional, Jordan, Karin, additional, Goldschmidt, Hartmut, additional, Raab, Marc S., additional, and Giesen, Nicola, additional

Published
2020
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13. Safety and Preliminary Efficacy Results from a Phase II Study Evaluating Combined BRAF and MEK Inhibition in Relapsed/Refractory Multiple Myeloma (rrMM) Patients with Activating BRAF V600E Mutations: The GMMG-Birma Trial

Author

Raab, Marc S., primary, Giesen, Nicola, additional, Scheid, Christof, additional, Besemer, Britta, additional, Miah, Kaya, additional, Benner, Axel, additional, Metzler, Ivana, additional, Khandanpour, Cyrus, additional, Seidel-Glaetzer, Andrea, additional, Trautmann-Grill, Karolin, additional, Mechtersheimer, Gunhild, additional, Goeppert, Benjamin, additional, Stenzinger, Albrecht, additional, Goldschmidt, Hartmut, additional, Weisel, Katja, additional, and Chatterjee, Manik, additional

Published
2020
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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. 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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16. 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, Duerig, 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., Haenel, Mathias, Benner, Axel, Salwender, Hans J., Goldschmidt, Hartmut, Mai, Elias K., Miah, Kaya, Bertsch, Uta, Duerig, 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., Haenel, 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-rankp = 0.73), overall survival (log-rankp = 0.54) as well as time-to-progression (Gray'sp = 0.83) and non-relapse mortality (Gray'sp = 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.

17. 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, Duerig, 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., Haenel, Mathias, Benner, Axel, Salwender, Hans J., Goldschmidt, Hartmut, Mai, Elias K., Miah, Kaya, Bertsch, Uta, Duerig, 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., Haenel, 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-rankp = 0.73), overall survival (log-rankp = 0.54) as well as time-to-progression (Gray'sp = 0.83) and non-relapse mortality (Gray'sp = 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.

18. Efficacy and safety of autologous stem cell transplantation in first-line treatment and at relapse in elderly patients with multiple myeloma.

Author

Klein EM, Hujic S, Miah K, Benner A, Merz M, Bertsch U, Weinhold N, Goldschmidt H, and Sauer S

Abstract

Introduction Although recent data suggest that Melphalan high-dose therapy followed by autologous stem cell transplantation (HDT/ASCT) is safe and effective in eligible multiple myeloma (MM) patients up to the age of 75 years, its value in elderly MM patients is still controversially discussed. Methods We retrospectively analyzed 607 MM patients ≥ 60 years old, who were admitted to our institution for first-line or salvage HDT/ASCT between January 2007 and October 2018. We assigned them to three groups according to age at HDT/ASCT: 60-64 years (S1), 65-69 years (S2) and ≥ 70 years (S3). We compared progression-free and overall survival, duration of hospitalization, complications, transfers to intermediate or intensive care unit, readmissions after discharge and deaths within 100 days after HDT/ASCT between these groups. Results Age did not impact progression-free and overall survival after first-line and salvage HDT/ASCT. Patients ≥ 70 years old at first HDT/ASCT had a longer hospitalization compared to patients 60-64 years old, however, the difference in the length of hospitalization was only marginal. Rates of febrile neutropenia, mucositis, transfers to intermediate or intensive care unit, readmissions after discharge and deaths within 100 days after HDT/ASCT were similar in the three age groups of patients receiving first or salvage HDT/ASCT. Patients with a Charlson Comorbidity Index ≥ 2 receiving first HDT/ASCT had a higher risk for a transfer to intermediate or intensive care unit. Conclusion Our analysis shows that HDT/ASCT is safe and effective in eligible elderly MM patients in first-line treatment and at relapse. A careful patient selection according to biological rather than chronological age is of crucial importance., (S. Karger AG, Basel.)

Published
2024
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19. Cytomegalovirus immunoglobulin serology prevalence in patients with newly diagnosed multiple myeloma treated within the GMMG-MM5 phase III trial.

Author

Salwender H, Weinhold N, Benner A, Miah K, Merz M, Haenel M, Jehn C, Mai E, Menis E, Blau I, Scheid C, Hose D, Seckinger A, Luntz S, Besemer B, Munder M, Brossart P, Glass B, Lindemann HW, Weisel K, Hanoun C, Schnitzler P, Klemm S, Goldschmidt H, Raab M, and Elmaagacli A

Subjects
Humans, Cytomegalovirus, Prevalence, Seroepidemiologic Studies, Transplantation, Autologous, Immunoglobulins, Intravenous, Antibodies, Viral, Immunoglobulin G, Immunoglobulin M, Hematopoietic Stem Cell Transplantation, Multiple Myeloma diagnosis, Multiple Myeloma therapy, Cytomegalovirus Infections epidemiology
Abstract

Objectives: The seroprevalence of antibodies against Cytomegalovirus (CMV) is an established poor prognostic factor for patients receiving an allogeneic stem cell transplantation. However, the impact of CMV serology on outcome after autologous stem cell transplantation remains unknown., Methods: Here, we analyzed the CMV immunoglobulin (Ig) serology of 446 newly-diagnosed multiple myeloma (MM) patients of the GMMG-MM5 phase III trial with a median follow-up of 58 months., Results: CMV IgG and IgM positivity was seen in 51% and 6% of the patients, respectively. In multivariate analysis CMV IgG and CMV IgM serology show an age-depending effect for PFS. We identified positive CMV IgG/positive CMV IgM serology as an age-depending beneficial factor on PFS., Discussion: Younger patients with a positive CMV IgG/positive CMV IgM serology experienced a favorable effect on PFS, whereas a positive CMV IgG/positive CMV IgM serology at older age has a disadvantageous effect on PFS.

Published
2024
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