Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 Apr 17;145(16):1780-1787.
doi: 10.1182/blood.2024027342.

Salvage autologous transplant in relapsed multiple myeloma: long-term follow-up of the phase 3 GMMG ReLApsE trial

Marc-Andrea Baertsch  1   2 , Jana Schlenzka  1 , Thomas Hielscher  3 , Marc S Raab  1   2   4 , Sandra Sauer  1 , Maximilian Merz  5 , Elias Karl Mai  1 , Carsten Müller-Tidow  1   4 , Steffen Luntz  6 , Anna Jauch  7 , Peter Brossart  8 , Martin Goerner  9 , Stefan Klein  10 , Bertram Glass  11 , Peter Reimer  12 , Ullrich Graeven  13 , Roland Fenk  14 , Mathias Haenel  15 , Ivana von Metzler  16 , Hans W Lindemann  17 , Christof Scheid  18 , Igor-Wolfgang Blau  19 , Hans J Salwender  20 , Richard Noppeney  21 , Britta Besemer  22 , Katja C Weisel  23 , Hartmut Goldschmidt  1   4
Affiliations
Clinical Trial

Salvage autologous transplant in relapsed multiple myeloma: long-term follow-up of the phase 3 GMMG ReLApsE trial

Marc-Andrea Baertsch et al. Blood. .

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.

PubMed Disclaimer

Conflict of interest statement

Conflict-of-interest disclosure: M.-A.B. reports consultancy with Takeda and Novartis; received honoraria from Takeda, Novartis, Sanofi, and Stemline; received travel support from Celgene, Amgen, Janssen, and Sanofi; and received research funding from Novartis and Sanofi. M.S.R. reports consultancy with, honoraria from, and membership on an entity's board of directors or advisory committees of, Janssen; AbbVie, GlaxoSmithKline (GSK), Bristol Myers Squibb (BMS), Sanofi and Amgen; and received research funding from Janssen, BMS, Sanofi, and Heidelberg Pharma. M.M. reports honoraria from Amgen, Takeda, BMS, Janssen, Stemline, and Roche. E.K.M. reports a consulting or advisory role with Amgen, BMS/Celgene, GSK, Janssen-Cilag, Oncopeptides, Pfizer, Sanofi, Stemline, and Takeda; reports honoraria from Amgen, BMS/Celgene, GSK, Janssen-Cilag, Oncopeptides, Pfizer, Sanofi, Stemline, and Takeda; reports research funding from BMS/Celgene, GSK, Janssen-Cilag, Sanofi, and Takeda; and reports travel accommodations and expenses from BMS/Celgene, GSK, Janssen-Cilag, Sanofi, Stemline, and Takeda. S.K. reports honoraria from Amgen. B.G. reports consultancy/advisory board membership with Roche, Kite, and Novartis; reports grants from, or contracts with, Roche, Kite, and Novartis; received honoraria from Roche, Kite, and Novartis; and received travel support from Roche, Kite, and Novartis. U.G. reports stock and other ownership interests in BioNTech; reports honoraria from Boehringer Ingelheim, Amgen, AstraZeneca, BMS, Merck Sharp & Dohme (MSD) Oncology, Sanofi, Fujifilm, Novartis, Cellrion, and Ipsen; reports consultancy/advisory board membership with Amgen and MSD Oncology; received research funding from Ipsen, MacroGenics; and reports travel support from Boehringer Ingelheim, and GSK. R.F. reports honoraria from Janssen, Amgen, GSK, Takeda, and BMS. M.H. reports consultancy with Novartis, BMS/Celgene, Gilead, Pfizer, Incyte, Sanofi/Aventis, Roche, Amgen, Sobi, and Janssen; and reports honoraria from Novartis, Sobi, Gilead, and Falk Foundation. I.v.M. reports consultancy with Takeda, Pfizer, Sanofi, and BMS. C.S. reports consultancy/advisory board membership with BMS, GSK, Janssen, Pfizer, Roche, and Takeda; reports honoraria from Amgen, BMS, GSK, Janssen, MSD, Novartis, Roche, Sanofi, and Takeda; reports research funding from Janssen and Takeda; and received travel support from BMS, Janssen, Sanofi Aventis, and Takeda. H.J.S. reports consultancy/advisory board membership with Amgen, AstraZeneca, BMS/Celgene, Genzyme, GSK, Janssen-Cilag, Oncopeptides, Pfizer, Sanofi, and Stemline; reports honoraria from AbbVie, Amgen, AstraZeneca, BMS/Celgene, Genzyme, GSK, Janssen-Cilag, Oncopeptides, Pfizer, Roche, Sanofi, Stemline, and Takeda; and received travel support from Amgen, BMS/Celgene, Janssen-Cilag, and Sanofi. B.B. reports honoraria from Janssen-Cilag, Amgen, Sanofi, GSK, and Pfizer; and travel support from Janssen-Cilag, Amgen, and Sanofi. K.C.W. reports consultancy/advisory board membership with AbbVie, Amgen, Adaptive Biotech, BMS/Celgene, BeiGene, Janssen, GSK, Karyopharm, Oncopeptides, Pfizer, Regeneron, Roche Pharma, Sanofi, Takeda, and Menarini; reports honoraria from AbbVie, Amgen, Adaptive Biotech, AstraZeneca, BMS/Celgene, BeiGene, Janssen, GSK, Karyopharm, Novartis, Oncopeptides, Pfizer, Roche Pharma, Sanofi, Stemline, Takeda, and Menarini; and received research funding from AbbVie, Amgen, BMS/Celgene, Janssen, GSK, Pfizer, Sanofi, and Takeda. H.G. reports consultancy/advisory board membership with Amgen, BMS, Janssen, Sanofi, and Adaptive Biotechnology; received honoraria from Amgen, BMS, Chugai, GSK, Janssen, Novartis, Sanofi, and Pfizer; received research funding from Amgen, BMS, Celgene, GlycoMimetics Inc, GSK, Heidelberg Pharma, Hoffmann-La Roche, Karyopharm, Janssen, Incyte Corporation, Millenium Pharmaceuticals Inc, Molecular Partners, Merck Sharp and Dohme, MorphoSys AG, Pfizer, Sanofi, Takeda, and Novartis; received travel support from Amgen, BMS, GSK, Janssen, Novartis, Sanofi, and Pfizer; reports grants from Amgen, Array Biopharma/Pfizer, BMS/Celgene, Chugai, Dietmar Hopp Foundation, Janssen, Johns Hopkins University, Mundipharma GmbH, and Sanofi. The remaining authors declare no competing financial interests.

A list of the German-Speaking Myeloma Multicenter Group trial sites and investigators involved in the ReLApsE trial appears in “Appendix.”

Figures

None
Graphical abstract
Figure 1.
Figure 1.
PFS and OS from randomization. Kaplan-Meier curves of PFS and OS in the intention-to-treat population by trial arm (A) and by TTP1 (B), as well as in the subgroup with TTP1 of >48 months by trial arm (C).
Figure 2.
Figure 2.
PFS and OS from the landmark at HDCT/ASCT and LEN/DEX cycle 5. PFS and OS from the landmark by trial arm as Kaplan-Meier curves in all patients that reached the landmark (A) and in the subgroup of patients with TTP1 of >48 months (B).
See this image and copyright information in PMC

Comment in

References

    1. Dimopoulos MA, Moreau P, Terpos E, et al. Multiple myeloma: EHA-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2021;32(3):309–322. - PubMed
    1. Kumar SK, Callander NS, Adekola K, et al. Multiple myeloma, version 2.2024, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Cancer Netw. 2023;21(12):1281–1301. - PubMed
    1. Giralt S, Garderet L, Durie B, et al. American Society of Blood and Marrow Transplant, European Society of Blood and Marrow Transplantation, Blood and Marrow Transplant Clinical Trials Network and International Myeloma Working Group consensus conference on salvage hematopoietic cell transplant. Biol Blood Marrow Transplant. 2015;21(12):2039–2051. - PMC - PubMed
    1. Cook G, Ashcroft AJ, Cairns DA, et al. The effect of salvage autologous stem-cell transplantation on overall survival in patients with relapsed multiple myeloma (final results from BSBMT/UKMF Myeloma X Relapse [Intensive]): a randomised, open-label, phase 3 trial. Lancet Haematol. 2016;3(7):e340–e351. - PubMed
    1. Goldschmidt H, Baertsch M-A, Schlenzka J, et al. Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE. Leukemia. 2021;35(4):1134–1144. - PubMed

Publication types