Journal Article

DKFZ-2020-01497

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE.

Goldschmidt, H. ; Baertsch, M.-A. ; Schlenzka, J. ; Becker, N.DKFZ* ; Habermehl, C.DKFZ* ; Hielscher, T.DKFZ* ; Raab, M.-S.DKFZ* ; Hillengass, J. ; Sauer, S. ; Müller-Tidow, C. ; Luntz, S. ; Jauch, A. ; Hose, D. ; Seckinger, A. ; Brossart, P. ; Goerner, M. ; Klein, S. ; Schmidt-Hieber, M. ; Reimer, P. ; Graeven, U. ; Fenk, R. ; Haenel, M. ; Martin, H. ; Lindemann, H. W. ; Scheid, C. ; Nogai, A. ; Salwender, H. ; Noppeney, R. ; Besemer, B. ; Weisel, K. ; Group, G. M. M. (Collaboration Author)

2021
Springer Nature London

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Please use a persistent id in citations: doi:10.1038/s41375-020-0948-0

Abstract: 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.

Note: 2021 Apr;35(4):1134-1144

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Contributing Institute(s):

1. C060 Biostatistik (C060)
2. KKE Mol. Hämatologie/Onkologie (A360)

Research Program(s):

1. 311 - Zellbiologie und Tumorbiologie (POF4-311) (POF4-311)

Appears in the scientific report 2021

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Database coverage:
; BIOSIS Previews ; Biological Abstracts ; Clarivate Analytics Master Journal List ; Current Contents - Life Sciences ; Ebsco Academic Search ; Essential Science Indicators ; IF >= 5 ; JCR ; NCBI Molecular Biology Database ; SCOPUS ; Science Citation Index ; Science Citation Index Expanded ; Web of Science Core Collection

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