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1. Single versus tandem autologous stem cell transplantation in newly diagnosed multiple myeloma

Author

Grieb, Nora, Oeser, Alexander, Ferle, Maximilian, Hanke, Franziska, Flossdorf, Sarah, Sauer, Sandra, Goldschmidt, Hartmut, Müller-Tidow, Carsten, Salwender, Hans-Jürgen, Fenk, Roland, Engelhardt, Monika, Zeiser, Robert, Vucinic, Vladan, Franke, Georg-Nikolaus, Blau, Igor Wolfgang, Teschner, Daniel, Einsele, Hermann, Kimmich, Christoph, Kull, Miriam, Besemer, Britta, Gagelmann, Nico, Kröger, Nicolaus, Neumuth, Thomas, Platzbecker, Uwe, and Merz, Maximilian

Published
2024
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2. Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone Induction Therapy for Transplant-Eligible Newly Diagnosed Multiple Myeloma: Final Part 1 Analysis of the GMMG-HD7 Trial

Author

Mai, Elias K., Bertsch, Uta, Pozek, Ema, Fenk, Roland, Besemer, Britta, Hanoun, Christine, Schroers, Roland, von Metzler, Ivana, Hänel, Mathias, Mann, Christoph, Leypoldt, Lisa B., Heilmeier, Bernhard, Huhn, Stefanie, Vogel, Sabine K., Hundemer, Michael, Scheid, Christof, Blau, Igor W., Luntz, Steffen, Weinhold, Niels, Tichy, Diana, Holderried, Tobias A.W., Trautmann-Grill, Karolin, Gezer, Deniz, Klaiber-Hakimi, Maika, Müller, Martin, Shumilov, Evgenii, Knauf, Wolfgang, Michel, Christian S., Geer, Thomas, Riesenberg, Hendrik, Lutz, Christoph, Raab, Marc S., Benner, Axel, Hoffmann, Martin, Weisel, Katja C., Salwender, Hans J., Goldschmidt, Hartmut, Ahlborn, Miriam, Behringer, Joachim, Bernhard, Helga, Besemer, Britta, Bittenbring, Jörg, Blau, Igor Wolfgang, Bolling, Claus, Boquoi, Amelie, Debatin, Daniel, Egerer, Gerlinde, Fenk, Roland, Ferstl, Barbara, Fronhoffs, Stefan, Gaska, Tobias, Geer, Thomas, Gezer, Deniz, Goldschmidt, Hartmut, Görner, Martin, Graeven, Ullrich, Hänel, Mathias, Heilmeier, Bernhard, Heinsch, Michael, Hoffmann, Martin, Holderried, Tobias A.W., Hopfer, Olaf, Janjetovic, Snjezana, Klaiber-Hakimi, Maika, Klausmann, Martine, Klein, Stefan, Knauf, Wolfgang, Ko, Yon-Dschun, Kraemer, Doris Maria, Kropff, Martin, La Rosée, Paul, Mahlberg, Rolf, Mann, Christoph, Martens, Uwe, von Metzler, Ivana, Michel, Christian, Müller, Martin, Pönisch, Wolfram, Reimer, Peter, Riechel, Claudia, Ringhoffer, Mark, Rummel, Mathias, Runde, Volker, Salwender, Hans Jürgen, Schaich, Markus, Scheid, Christoph, Schmidt-Hieber, Martin, Schöndube, Daniel, Schroers, Roland, Schütte, Hans-Joachim, Shumilov, Evgenii, Staib, Peter, Strumberg, Dirk, Tischler, Hans-Joachim, Trautmann-Grill, Karolin, Verbeek, Walter, Weide, Rudolf, Weidmann, Eckhart, Weisel, Katja, de Wit, Maike, Bernhardt, Christiane, Fietz, Thomas, Grassinger, Jochen, Köchling, Georg, Neise, Michael, Schmitt, Stefan, Steiniger, Heike, Tschechne, Barbara, Whitlock, Bettina, Zaiß, Matthias, and Ziske, Carsten

Published
2024
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3. 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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5. 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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6. Measurable residual disease monitoring in AML with FLT3-ITD treated with intensive chemotherapy plus midostaurin

Author

Rücker, Frank G., Bullinger, Lars, Cocciardi, Sibylle, Skambraks, Sabrina, Luck, Tamara J., Weber, Daniela, Krzykalla, Julia, Pozek, Ema, Schneider, Isabelle, Corbacioglu, Andrea, Gaidzik, Verena I., Meid, Annika, Aicher, Sophia, Stegelmann, Frank, Schrade, Anika, Theis, Frauke, Fiedler, Walter, Salih, Helmut R., Wulf, Gerald, Salwender, Hans, Schroeder, Thomas, Götze, Katharina S., Kühn, Michael W. M., Lübbert, Michael, Schlenk, Richard F., Benner, Axel, Thol, Felicitas, Heuser, Michael, Ganser, Arnold, Döhner, Hartmut, and Döhner, Konstanze

Published
2024
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8. 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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9. 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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11. Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone as induction therapy for newly diagnosed, transplantation-eligible patients with multiple myeloma (GMMG-HD7): part 1 of an open-label, multicentre, randomised, active-controlled, phase 3 trial

Author

Asemissen, Anne M, Behringer, Joachim, Bernhard, Helga, Bernhardt, Christiane, Bertsch, Uta, Besemer, Britta, Blau, Igor W, Bolling, Claus, Debatin, Daniel, Dingeldein, Gerrit, Dürig, Jan, Fenk, Roland, Ferstl, Barbara, Fest, Claudia, Fronhoffs, Stefan, Fuhrmann, Stephan, Gaska, Tobias, Geer, Thomas, Gezer, Deniz, Goldschmidt, Hartmut, Görner, Martin, Graeven, Ullrich, Grassinger, Jochen, Hänel, Mathias, Heilmeier, Bernhard, Heinsch, Michael, Held, Gerhard, Hoffmann, Martin, Holderried, Tobias A W, Hopfer, Olaf, Huhn, Stefanie, Immenschuh, Peter, Kaddu-Mulindwa, Dominic, Khandanpour, Cyrus, Klaiber-Hakimi, Maika, Klausmann, Martine, Klein, Stefan, Knauf, Wolfgang, Ko, Yon-Dschun, Köchling, Georg, Koenigsmann, Michael, Kostrewa, Philippe, Kraemer, Doris Maria, Kremers, Stephan, Kriegsmann, Katharina, Kropff, Martin, La Rosée, Paul, Luntz, Steffen P, Mahlberg, Rolf, Mai, Elias K, Mann, Christoph, Martens, Uwe, von Metzler, Ivana, Müller, Martin, Munder, Markus, Neise, Michael, Nievergall, Eva, Nückel, Holger, Pönisch, Wolfram, Procaccianti, Maria, Raab, Marc S, Rafiyan, Mohammed R, Reimer, Peter, Riecke, Armin, Riesenberg, Hendrik, Rummel, Mathias, Runde, Volker, Salwender, Hans J, Schaich, Markus, Scheid, Christoph, Schmidt-Hieber, Martin, Schmitt, Stefan, Schöndube, Daniel, Schroers, Roland, Schwarzer, Andreas, Staib, Peter, Steiniger, Heike, Sturmberg, Dirk, Thomalla, Jörg, Tichy, Diana, Tischler, Hans-Joachim, Trautmann-Grill, Karolin, Trummer, Arne, Tschechne, Barbara, Verbeek, Walter, Weinhold, Niels, Weisel, Katja C, Whitlock, Bettina, de Wit, Maike, Zaiß, Matthias, Ziske, Carsten, and Scheid, Christof

Published
2022
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12. 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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13. Plain language summary of isatuximab plus carfilzomib, lenalidomide, and dexamethasone for the treatment of people with high-risk newly diagnosed multiple myeloma.

Author

Leypoldt, Lisa B., Tichy, Diana, Besemer, Britta, Hanel, Mathias, Raab, Marc S., Mann, Christoph, Munder, Markus, Reinhardt, Hans Christian, Nogai, Axel, Gorner, Martin, Ko, Yon-Dschun, de Wit, Maike, Salwender, Hans, Scheid, Christof, Graeven, Ullrich, Peceny, Rudolf, Staib, Peter, Dieing, Annette, Einsele, Hermann, and Jauch, Anna

Abstract

Plain Language Summary What is this summary about? This is a summary of a publication about the GMMG-CONCEPT study that was published in the Journal of Clinical Oncology in September 2023. The study tested if a combination of cancer drugs (isatuximab plus carfilzomib, lenalidomide, and dexamethasone, or Isa-KRd for short) was a safe treatment for people with high-risk newly diagnosed multiple myeloma. The GMMG-CONCEPT study included participants who had not been treated before and were eligible to receive a procedure called autologous stem cell transplant, as well as participants who were not eligible to receive transplants. How was the study in this summary conducted? This report looked at a total of 125 participants; 99 were transplant-eligible and 26 were transplant-non-eligible. All participants were treated with Isa-KRd. The researchers measured the proportion of people who had 'no detectable levels' of myeloma cells in their body left while on treatment (called minimal residual disease negativity, or MRD negativity for short). The researchers measured the progression-free survival, or the average length of time it took between the participants joining the study until their cancer got worse or they died. The researchers also measured overall survival, which is the total amount of time people lived during the study, even if their cancer got worse. The researchers also monitored for side effects of Isa-KRd in all participants that received at least one treatment. What were the results of the study? At the end of the consolidation therapy (intensified therapy that happens after initial therapy), MRD negativity was observed in the majority of transplant-eligible and transplant non-eligible patients. For many patients, this effect lasted 6 or more months. After more than 3 years in transplant eligible participants and 2 years and 9 months for transplant non-eligible participants, most participants were alive and their disease did not get worse. In both groups, the most common side effects of Isa-KRd treatment were low blood cell counts and infections. Overall, most of the side effects did not last long or were easily treated. What were the main conclusions reported by the researchers? In the GMMG-CONCEPT study, Isa-KRd treatment reduced the number of myeloma cells to no detectable levels in more than two thirds of the participants with high-risk newly diagnosed multiple myeloma. Clinical Trial Registration:NCT03104842 (ClinicalTrials.gov) [ABSTRACT FROM AUTHOR]

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

Author

Salwender, Hans, Weinhold, Niels, Benner, Axel, Miah, Kaya, Merz, Maximilian, Haenel, Mathias, Jehn, Christian, Mai, Elias, Menis, Ekaterina, Blau, Igor, Scheid, Christof, Hose, Dirk, Seckinger, Anja, Luntz, Steffen, Besemer, Britta, Munder, Markus, Brossart, Peter, Glass, Bertram, Lindemann, Hans-Walter, and Weisel, Katja

Subjects
*CLINICAL trials, *STEM cell transplantation, *MULTIPLE myeloma, *PROGNOSIS, *SEROLOGY
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. [ABSTRACT FROM AUTHOR]

Published
2024
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15. Bortezomib before and after high‐dose therapy in transplant‐eligible patients with newly diagnosed multiple myeloma: Long‐term overall survival after more than 10 years of follow‐up from the phase III HOVON‐65/GMMG‐HD4 trial

Author

Mai, Elias K., Nogai, Axel, Lokhorst, Henk M., van der Holt, Bronno, Zweegman, Sonja, Weisel, Katja C., Croockewit, Sandra, Jauch, Anna, Hillengass, Jens, Stevens‐Kroef, Marian, Raab, Marc S., Broijl, Annemiek, Bos, Gerard M. J., Brossart, Peter, Ypma, Paula, Hanoun, Christine, Bertsch, Uta, Hielscher, Thomas, Salwender, Hans J., and Scheid, Christoph

Published
2024
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16. 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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18. 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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19. 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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20. 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

22. 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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23. 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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24. 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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25. Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone for the Treatment of High-Risk Newly Diagnosed Multiple Myeloma

Author

Leypoldt, Lisa B., primary, Tichy, Diana, additional, Besemer, Britta, additional, Hänel, Mathias, additional, Raab, Marc S., additional, Mann, Christoph, additional, Munder, Markus, additional, Reinhardt, Hans Christian, additional, Nogai, Axel, additional, Görner, Martin, additional, Ko, Yon-Dschun, additional, de Wit, Maike, additional, Salwender, Hans, additional, Scheid, Christof, additional, Graeven, Ullrich, additional, Peceny, Rudolf, additional, Staib, Peter, additional, Dieing, Annette, additional, Einsele, Hermann, additional, Jauch, Anna, additional, Hundemer, Michael, additional, Zago, Manola, additional, Požek, Ema, additional, Benner, Axel, additional, Bokemeyer, Carsten, additional, Goldschmidt, Hartmut, additional, and Weisel, Katja C., additional

Published
2023
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26. 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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27. OA-43 Analysis of sustained MRD-negativity and progression-free survival of Isa-KRd in high-risk newly diagnosed multiple myeloma – additional data from planned interim analysis of the GMMG-CONCEPT trial

Author

Leypoldt, Lisa, primary, Tichy, Diana, additional, Besemer, Britta, additional, Hänel, Mathias, additional, Raab, Marc, additional, Mann, Christoph, additional, Munder, Markus, additional, Reinhardt, Hans Christian, additional, Nogai, Axel, additional, Görner, Martin, additional, Ko, Yon-Dschun, additional, de Wit, Maike, additional, Salwender, Hans, additional, Scheid, Christof, additional, Graeven, Ullrich, additional, Peceny, Rudolf, additional, Staib, Peter, additional, Dieing, Annette, additional, Einsele, Hermann, additional, Jauch, Anna, additional, Zago, Manola, additional, Benner, Axel, additional, Bokemeyer, Carsten, additional, Goldschmidt, Hartmut, additional, and Weisel, Katja, additional

Published
2023
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28. 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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29. 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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30. 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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31. 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

32. Isatuximab, Carfilzomib, Lenalidomide, and Dexamethasone for the Treatment of High-Risk Newly Diagnosed Multiple Myeloma.

Author

Leypoldt, Lisa B., Tichy, Diana, Besemer, Britta, Hänel, Mathias, Raab, Marc S., Mann, Christoph, Munder, Markus, Reinhardt, Hans Christian, Nogai, Axel, Görner, Martin, Ko, Yon-Dschun, de Wit, Maike, Salwender, Hans, Scheid, Christof, Graeven, Ullrich, Peceny, Rudolf, Staib, Peter, Dieing, Annette, Einsele, Hermann, and Jauch, Anna

Published
2024
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33. 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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34. 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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35. 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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36. 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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37. 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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38. 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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39. 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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40. Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone as induction therapy for newly diagnosed, transplantation-eligible patients with multiple myeloma (GMMG-HD7): part 1 of an open-label, multicentre, randomised, active-controlled, phase 3 trial

Author

Goldschmidt, Hartmut, primary, Mai, Elias K, additional, Bertsch, Uta, additional, Fenk, Roland, additional, Nievergall, Eva, additional, Tichy, Diana, 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, Weinhold, Niels, additional, Huhn, Stefanie, additional, Kriegsmann, Katharina, additional, Luntz, Steffen P, additional, Holderried, Tobias A W, additional, Trautmann-Grill, Karolin, additional, Gezer, Deniz, additional, Klaiber-Hakimi, Maika, additional, Müller, Martin, additional, Khandanpour, Cyrus, additional, Knauf, Wolfgang, additional, Scheid, Christof, additional, Munder, Markus, additional, Geer, Thomas, additional, Riesenberg, Hendrik, additional, Thomalla, Jörg, additional, Hoffmann, Martin, additional, Raab, Marc S, additional, Salwender, Hans J, additional, Weisel, Katja C, additional, Behringer, Joachim, additional, Bernhard, Helga, additional, Bernhardt, Christiane, additional, Blau, Igor W, additional, Bolling, Claus, additional, Debatin, Daniel, additional, Dingeldein, Gerrit, additional, Ferstl, Barbara, additional, Fest, Claudia, additional, Fronhoffs, Stefan, additional, Fuhrmann, Stephan, additional, Gaska, Tobias, additional, Goldschmidt, Hartmut, additional, Görner, Martin, additional, Graeven, Ullrich, additional, Grassinger, Jochen, additional, Heinsch, Michael, additional, Held, Gerhard, additional, Hopfer, Olaf, additional, Immenschuh, Peter, additional, Kaddu-Mulindwa, Dominic, additional, Klausmann, Martine, additional, Klein, Stefan, additional, Ko, Yon-Dschun, additional, Köchling, Georg, additional, Koenigsmann, Michael, additional, Kostrewa, Philippe, additional, Kraemer, Doris Maria, additional, Kremers, Stephan, additional, Kropff, Martin, additional, La Rosée, Paul, additional, Mahlberg, Rolf, additional, Martens, Uwe, additional, Neise, Michael, additional, Nückel, Holger, additional, Pönisch, Wolfram, additional, Procaccianti, Maria, additional, Rafiyan, Mohammed R, additional, Reimer, Peter, additional, Riecke, Armin, additional, Rummel, Mathias, additional, Runde, Volker, additional, Schaich, Markus, additional, Scheid, Christoph, additional, Schmidt-Hieber, Martin, additional, Schmitt, Stefan, additional, Schöndube, Daniel, additional, Schwarzer, Andreas, additional, Staib, Peter, additional, Steiniger, Heike, additional, Sturmberg, Dirk, additional, Tischler, Hans-Joachim, additional, Trummer, Arne, additional, Tschechne, Barbara, additional, Verbeek, Walter, additional, Whitlock, Bettina, additional, de Wit, Maike, additional, Zaiß, Matthias, additional, and Ziske, Carsten, additional

Published
2022
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41. 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, primary, Cairns, David A., additional, Lahuerta, Juan José, additional, Wester, Ruth, additional, Bertsch, Uta, additional, Waage, Anders, additional, Zamagni, Elena, additional, Mateos, María-Victoria, additional, Dall'Olio, Daniele, additional, van de Donk, Niels W.C.J., additional, Jackson, Graham, additional, Rocchi, Serena, additional, Salwender, Hans, additional, Bladé Creixenti, Joan, additional, van der Holt, Bronno, additional, Castellani, Gastone, additional, Bonello, Francesca, additional, Capra, Andrea, additional, Mai, Elias K., additional, Dürig, Jan, additional, Gay, Francesca, additional, Zweegman, Sonja, additional, Cavo, Michele, additional, Kaiser, Martin F., additional, Goldschmidt, Hartmut, additional, Hernández Rivas, Jesús María, additional, Larocca, Alessandra, additional, Cook, Gordon, additional, San-Miguel, Jesús F., additional, Boccadoro, Mario, additional, and Sonneveld, Pieter, additional

Published
2022
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43. 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

44. 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

45. 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

46. 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

47. Immunological Subgroups Predicting Efficacy of Elotuzumab in Multiple Myeloma Patients: Insights from the GMMG-HD6 Clinical Trial

Author

Ton, Gigi Nu Hoang Quy, Kriegsmann, Katharina, Awwad, Mohamed H.S., Benner, Axel, Bertsch, Uta, Besemer, Britta, Hänel, Mathias, Fenk, Roland, Schlenzka, Jana, Munder, Markus, Dürig, Jan, Blau, Igor Wolfgang, Huhn, Stefanie, Hose, Dirk, Jauch, Anna, Neubauer, Andreas, Weinhold, Niels, Scheid, Christof, Schroers, Roland, von Metzler, Ivana, Schieferdecker, Aneta, Thomalla, Jörg, Reimer, Peter, Mahlberg, Rolf, Graeven, Ullrich, Kremers, Stephan, Martens, Uwe, Kunz, Christian, Hensel, Manfred, Seidel-Glätzer, Andrea, Weisel, Katja, Salwender, Hans, Müller-Tidow, Carsten, Raab, Marc S., Goldschmidt, Hartmut, Mai, Elias K., and Hundemer, Michael

Published
2023
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48. Salvage Autologous Transplant and Lenalidomide Maintenance Versus Continuous Lenalidomide/Dexamethasone for Relapsed Multiple Myeloma: Long Term Follow up Results of the Randomized GMMG Phase III Multicenter Trial Relapse

Author

Baertsch, Marc-Andrea, Schlenzka, Jana, Hielscher, Thomas, Raab, Marc S., Sauer, Sandra, Merz, Maximilian, Mai, Elias K., Müller-Tidow, Carsten, Luntz, Steffen, Jauch, Anna, Brossart, Peter, Goerner, Martin, Klein, Stefan, Glass, Bertram, Reimer, Peter, Graeven, Ullrich, Fenk, Roland, Hänel, Mathias, von Metzler, Ivana, Hans W., Lindemann, Scheid, Christof, Nogai, Axel, Salwender, Hans, Noppeney, Richard, Besemer, Britta, Weisel, Katja, and Goldschmidt, Hartmut

Published
2023
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49. 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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50. Midostaurin plus Intensive Chemotherapy for Younger and Older Patients with AML and FLT3Internal 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

Abstract

We conducted a single-arm phase-II trial (AMLSG 16-10) to evaluate midostaurin with intensive chemotherapy followed by allogeneic hematopoietic-cell transplantation (HCT) and a one-year midostaurin maintenance therapy in adult patients with acute myeloid leukemia (AML) and FLT3internal tandem duplication (ITD). Patients 18-70 years of age with newly diagnosed FLT3-ITD-positive AML were eligible. Primary and key secondary endpoints were event-free (EFS) and overall survival (OS). Results were compared to a historical cohort of 415 patients treated on 5 prior AMLSG trials; statistical analysis was performed using a double-robust adjustment with propensity score weighting and covariate adjustment. Results were also compared to patients (18-59yrs) treated on the placebo arm of the CALGB 10603/RATIFY trial. The trial accrued 440 patients (18-60yrs, n=312; 61-70yrs, n=128). In multivariate analysis, EFS was significantly in favor of patients treated within the AMLSG 16-10 trial compared to the AMLSG control (HR 0.55; P<0.001); both in younger (HR 0.59; P<0.001) and older patients (HR 0.42; P<0.001). Multivariate analysis also showed a significant beneficial effect on OS compared to the AMLSG control (HR 0.57; P<0.001) as well as to the CALGB 10603/RATIFY trial (HR 0.71; p=0.005). The treatment effect of midostaurin remained significant in sensitivity analysis including allogeneic HCT as a time-dependent covariate. Addition of midostaurin to chemotherapy was safe in younger and older patients. In comparison to historical controls, the addition of midostaurin to intensive therapy led to a significant improvement in outcome in younger and older patients with AML and FLT3-ITD. The AMLSG 16-10 trial is registered at clinicaltrialsregistry.eu(Eudra-CT number 2011-003168-63) and clinicaltrials.gov(NCT01477606).

Published
2022
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