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Salvage autologous transplant in relapsed multiple myeloma: long-term follow-up of the phase 3 GMMG ReLApsE trial$dbrief report : clinical trials and observations

The multicenter, phase 3 German-Speaking Myeloma Multicenter Group (GMMG) ReLApsE trial randomized patients with relapsed and/or refractory multiple myeloma (RRMM) equally to lenalidomide/dexamethasone (LEN/DEX; 25 mg days 1-21, DEX 40 mg weekly, in 4-week cycles) reinduction, salvage high-dose chem...

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Main Authors: Bärtsch, Marc-Andrea (Author) , Schlenzka, Jana (Author) , Hielscher, Thomas (Author) , Raab, Marc-Steffen (Author) , Sauer, Sandra (Author) , Merz, Maximilian (Author) , Mai, Elias K. (Author) , Müller-Tidow, Carsten (Author) , Luntz, Steffen P. (Author) , Jauch, Anna (Author) , Brossart, Peter (Author) , Görner, Martin (Author) , Klein, Stefan (Author) , Glaß, Bertram (Author) , Reimer, Peter (Author) , Graeven, Ullrich (Author) , Fenk, Roland (Author) , Hänel, Mathias (Author) , Metzler, Ivana von (Author) , Lindemann, Hans W. (Author) , Scheid, Christoph (Author) , Blau, Igor-Wolfgang (Author) , Salwender, Hans (Author) , Noppeney, Richard (Author) , Besemer, Britta (Author) , Weisel, Katja (Author) , Goldschmidt, Hartmut (Author)
Format: Article (Journal)
Language:English
Published: 17 April 2025
In: Blood
Year: 2025, Volume: 145, Issue: 16, Pages: 1780-1787
ISSN:1528-0020
DOI:10.1182/blood.2024027342
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1182/blood.2024027342
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Author Notes:Marc-Andrea Baertsch, Jana Schlenzka, Thomas Hielscher, Marc S. Raab, Sandra Sauer, Maximilian Merz, Elias Karl Mai, Carsten Müller-Tidow, Steffen Luntz, Anna Jauch, Peter Brossart, Martin Goerner, Stefan Klein, Bertram Glass, Peter Reimer, Ullrich Graeven, Roland Fenk, Mathias Haenel, Ivana von Metzler, Hans W. Lindemann, Christof Scheid, Igor-Wolfgang Blau, Hans J. Salwender, Richard Noppeney, Britta Besemer, Katja C. Weisel, and Hartmut Goldschmidt, for the German-Speaking Myeloma Multicenter Group
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Summary:The multicenter, phase 3 German-Speaking Myeloma Multicenter Group (GMMG) ReLApsE trial randomized patients with relapsed and/or refractory multiple myeloma (RRMM) equally to lenalidomide/dexamethasone (LEN/DEX; 25 mg days 1-21, DEX 40 mg weekly, in 4-week cycles) reinduction, salvage high-dose chemotherapy (sHDCT; melphalan 200 mg/m2), autologous stem cell transplantation (ASCT), and LEN maintenance (10 mg/d; transplant arm, n = 139) vs continuous LEN/DEX (control arm, n = 138). Ninety-four percent of patients had received frontline HDCT/ASCT. We report an updated analysis of survival end points with a median follow-up of 99 months. Median progression-free survival (PFS) was 20.5 and 19.3 months in the transplant and control arm, respectively (hazard ratio [HR], 0.98; P = .9). Median overall survival (OS) was 67.1 and 62.7 months, respectively, (HR 0.89; P = .44). Landmark analyses from sHDCT and the contemporaneous LEN/DEX cycle 5 were performed because of 29% dropout of patients before sHDCT/ASCT in the transplant arm but did not reveal significant differences in PFS/OS. Time to progression after frontline HDCT/ASCT was a prognostic factor but did not predict benefit from sHDCT/ASCT. The GMMG ReLApsE trial does not support use of sHDCT/ASCT in RRMM after frontline HDCT/ASCT. This trial was registered at www.clinicaltrialsregister.eu as #EudraCT2009-013856-61.
Item Description:Gesehen am 03.06.2025
Physical Description:Online Resource
ISSN:1528-0020
DOI:10.1182/blood.2024027342

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