Salvage autologous transplant in relapsed multiple myeloma: long-term follow-up of the phase 3 GMMG ReLApsE trial
Marc‐Andrea Baertsch, Jana Schlenzka, Thomas Hielscher, Marc S. Raab, Sandra Sauer, Maximilian Merz, K. Elias, Carsten Müller‐Tidow, Steffen Luntz, Anna Jauch, Peter Brossart, Martin Göerner, Stefan Klein, Bertram Glaß, Peter Reimer, Ullrich Graeven, Roland Fenk, Mathias Haenel, Ivana von Metzler, Hans‐Walter Lindemann, Christof Scheid, Igor Wolfgang Blau, Hans Salwender, Richard Noppeney, Britta Besemer, Katja Weisel, Hartmut Goldschmidt
Abstract
ABSTRACT: 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.