Goldschmidt, Hartmut, Baertsch, Marc-Andrea, Schlenzka, Jana, Becker, Natalia, Habermehl, Christina, Hielscher, Thomas, Raab, Marc-Steffen, Hillengass, Jens, Sauer, Sandra, Mueller-Tidow, Carsten, Luntz, Steffen, Jauch, Anna, Hose, Dirk, Seckinger, Anja, Brossart, Peter, Goerner, Martin, Klein, Stefan, Schmidt-Hieber, Martin, Reimer, Peter, Graeven, Ullrich, Fenk, Roland, Haenel, Mathias, Martin, Hans, Lindemann, Hans W., Scheid, Christoph, Nogai, Axel, Salwender, Hans, Noppeney, Richard, Besemer, Britta and Weisel, Katja . Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE. Leukemia. LONDON: NATURE PUBLISHING GROUP. ISSN 1476-5551

Full text not available from this repository.

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/m(2)), 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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Goldschmidt, HartmutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baertsch, Marc-AndreaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schlenzka, JanaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Becker, NataliaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Habermehl, ChristinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hielscher, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Raab, Marc-SteffenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hillengass, JensUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sauer, SandraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller-Tidow, CarstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Luntz, SteffenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jauch, AnnaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hose, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Seckinger, AnjaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Brossart, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goerner, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Klein, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmidt-Hieber, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reimer, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Graeven, UllrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fenk, RolandUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haenel, MathiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Martin, HansUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lindemann, Hans W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Scheid, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nogai, AxelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Salwender, HansUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Noppeney, RichardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Besemer, BrittaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weisel, KatjaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-325991
DOI: 10.1038/s41375-020-0948-0
Journal or Publication Title: Leukemia
Publisher: NATURE PUBLISHING GROUP
Place of Publication: LONDON
ISSN: 1476-5551
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
STEM-CELL TRANSPLANTATION; HIGH-DOSE CHEMOTHERAPY; PLUS DEXAMETHASONE; OPEN-LABEL; THERAPY; BORTEZOMIBMultiple languages
Oncology; HematologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/32599

Downloads

Downloads per month over past year

Altmetric

Export

Actions (login required)

View Item View Item