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

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 w...

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Hauptverfasser: Goldschmidt, Hartmut (VerfasserIn) , Bärtsch, Marc-Andrea (VerfasserIn) , Schlenzka, Jana (VerfasserIn) , Becker, Natalia (VerfasserIn) , Habermehl, Christina (VerfasserIn) , Hielscher, Thomas (VerfasserIn) , Raab, Marc-Steffen (VerfasserIn) , Hillengaß, Jens (VerfasserIn) , Sauer, Sandra (VerfasserIn) , Müller-Tidow, Carsten (VerfasserIn) , Luntz, Steffen P. (VerfasserIn) , Jauch, Anna (VerfasserIn) , Hose, Dirk (VerfasserIn) , Seckinger, Anja (VerfasserIn) , Brossart, Peter (VerfasserIn) , Goerner, Martin (VerfasserIn) , Klein, Stefan (VerfasserIn) , Schmidt-Hieber, Martin (VerfasserIn) , Reimer, Peter (VerfasserIn) , Graeven, Ullrich (VerfasserIn) , Fenk, Roland (VerfasserIn) , Haenel, Mathias (VerfasserIn) , Martin, Hans (VerfasserIn) , Lindemann, Hans W. (VerfasserIn) , Scheid, Christoph (VerfasserIn) , Nogai, Axel (VerfasserIn) , Salwender, Hans (VerfasserIn) , Noppeney, Richard (VerfasserIn) , Besemer, Britta (VerfasserIn) , Weisel, Katja (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 21 July 2020
In: Leukemia
Year: 2021, Jahrgang: 35, Heft: 4, Pages: 1134-1144
ISSN:1476-5551
DOI:10.1038/s41375-020-0948-0
Online-Zugang:Resolving-System, lizenzpflichtig, Volltext: https://doi.org/10.1038/s41375-020-0948-0
Verlag, lizenzpflichtig, Volltext: https://www.nature.com/articles/s41375-020-0948-0
Volltext
Verfasserangaben:Hartmut Goldschmidt, Marc-Andrea Baertsch, Jana Schlenzka, Natalia Becker, Christina Habermehl, Thomas Hielscher, Marc-Steffen Raab, Jens Hillengass, Sandra Sauer, Carsten Müller-Tidow, Steffen Luntz, Anna Jauch, Dirk Hose, Anja Seckinger, Peter Brossart, Martin Goerner, Stefan Klein, Martin Schmidt-Hieber, Peter Reimer, Ullrich Graeven, Roland Fenk, Mathias Haenel, Hans Martin, Hans W. Lindemann, Christoph Scheid, Axel Nogai, Hans Salwender, Richard Noppeney, Britta Besemer, Katja Weisel
Beschreibung
Zusammenfassung: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.
Beschreibung:Gesehen am 28.07.2020
Beschreibung:Online Resource
ISSN:1476-5551
DOI:10.1038/s41375-020-0948-0

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