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@ARTICLE{Baertsch:297962,
author = {M.-A. Baertsch and J. Schlenzka and T. Hielscher$^*$ and M.
S. Raab and S. Sauer and M. Merz and E. K. Mai and C.
Müller-Tidow and S. Luntz and A. Jauch and P. Brossart and
M. Goerner and S. Klein and B. Glass and P. Reimer and U.
Graeven and R. Fenk and M. Haenel and I. von Metzler and
H.-W. Lindemann and C. Scheid and I. W. Blau and H. J.
Salwender and R. Noppeney and B. Besemer and K. C. Weisel
and H. Goldschmidt},
title = {{S}alvage {A}utologous {T}ransplant in {R}elapsed
{M}ultiple {M}yeloma: {L}ong-{T}erm {F}ollow-{U}p of the
{P}hase 3 {GMMG} {R}e{LA}ps{E} {T}rial.},
journal = {Blood},
volume = {145},
number = {16},
issn = {0006-4971},
address = {Washington, DC},
publisher = {American Society of Hematology},
reportid = {DKFZ-2025-00139},
pages = {1780-1787},
year = {2025},
note = {2025 Apr 17;145(16):1780-1787},
abstract = {The multicenter, phase III GMMG ReLApsE trial
(EudraCT-No:2009-013856-61) randomized relapsed and/or
refractory multiple myeloma (RRMM) patients equally to
lenalidomide/dexamethasone (LEN/DEX, 25mg days 1-21/40mg
weekly, 4-week cycles) re-induction, salvage high dose
chemotherapy (sHDCT, melphalan 200mg/m2), autologous stem
cell transplantation (ASCT) and LEN maintenance (10mg/day;
transplant arm, n=139) versus continuous LEN/DEX (control
arm, n=138). Ninety-four percent of patients had received
frontline HDCT/ASCT. We report an updated analysis of
survival endpoints 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 (HR
0.98; $95\%$ CI 0.76-1.27; p=0.9). Median overall survival
(OS) was 67.1 and 62.7 months (HR 0.89; $95\%$ CI 0.66-1.20;
p=0.44). Landmark analyses from sHDCT and the
contemporaneous LEN/DEX cycle 5 were performed due to
dropout of $29\%$ of patients before sHDCT/ASCT in the
transplant arm but did not reveal significant differences in
PFS (23.0 vs. 20.3 months; HR 0.91; $95\%$ CI 0.68-1.22;
p=0.52) or OS (76.3 vs. 66.0 months; HR 0.8; $95\%$ CI
0.56-1.13; p=0.2). Time to progression after frontline
HDCT/ASCT (TTP1) 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.
EudraCT-No: 2009-013856-61.},
cin = {C060},
ddc = {610},
cid = {I:(DE-He78)C060-20160331},
pnm = {313 - Krebsrisikofaktoren und Prävention (POF4-313)},
pid = {G:(DE-HGF)POF4-313},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:39808798},
doi = {10.1182/blood.2024027342},
url = {https://inrepo02.dkfz.de/record/297962},
}