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000297962 1001_ $$00000-0002-4000-6904$$aBaertsch, Marc-Andrea$$b0
000297962 245__ $$aSalvage Autologous Transplant in Relapsed Multiple Myeloma: Long-Term Follow-Up of the Phase 3 GMMG ReLApsE Trial.
000297962 260__ $$aWashington, DC$$bAmerican Society of Hematology$$c2025
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000297962 500__ $$a2025 Apr 17;145(16):1780-1787
000297962 520__ $$aThe multicenter, phase III GMMG ReLApsE trial (EudraCT-No:2009-013856-61) randomized relapsed and/or refractory multiple myeloma (RRMM) patients equally to lenalidomide/dexamethasone (LEN/DEX, 25mg days 1-21/40mg weekly, 4-week cycles) re-induction, salvage high dose chemotherapy (sHDCT, melphalan 200mg/m2), autologous stem cell transplantation (ASCT) and LEN maintenance (10mg/day; transplant arm, n=139) versus continuous LEN/DEX (control arm, n=138). Ninety-four percent of patients had received frontline HDCT/ASCT. We report an updated analysis of survival endpoints with a median follow-up of 99 months. Median progression-free survival (PFS) was 20.5 and 19.3 months in the transplant and control arm, respectively (HR 0.98; 95% CI 0.76-1.27; p=0.9). Median overall survival (OS) was 67.1 and 62.7 months (HR 0.89; 95% CI 0.66-1.20; p=0.44). Landmark analyses from sHDCT and the contemporaneous LEN/DEX cycle 5 were performed due to dropout of 29% of patients before sHDCT/ASCT in the transplant arm but did not reveal significant differences in PFS (23.0 vs. 20.3 months; HR 0.91; 95% CI 0.68-1.22; p=0.52) or OS (76.3 vs. 66.0 months; HR 0.8; 95% CI 0.56-1.13; p=0.2). Time to progression after frontline HDCT/ASCT (TTP1) was a prognostic factor but did not predict benefit from sHDCT/ASCT. The GMMG ReLApsE trial does not support use of sHDCT/ASCT in RRMM after frontline HDCT/ASCT. EudraCT-No: 2009-013856-61.
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000297962 7001_ $$aSchlenzka, Jana$$b1
000297962 7001_ $$0P:(DE-He78)743a4a82daab55306a2c88b9f6bf8c2f$$aHielscher, Thomas$$b2$$udkfz
000297962 7001_ $$aRaab, Marc S$$b3
000297962 7001_ $$aSauer, Sandra$$b4
000297962 7001_ $$00000-0002-2805-5973$$aMerz, Maximilian$$b5
000297962 7001_ $$00000-0002-6226-1252$$aMai, Elias K$$b6
000297962 7001_ $$aMüller-Tidow, Carsten$$b7
000297962 7001_ $$aLuntz, Steffen$$b8
000297962 7001_ $$aJauch, Anna$$b9
000297962 7001_ $$aBrossart, Peter$$b10
000297962 7001_ $$aGoerner, Martin$$b11
000297962 7001_ $$aKlein, Stefan$$b12
000297962 7001_ $$aGlass, Bertram$$b13
000297962 7001_ $$aReimer, Peter$$b14
000297962 7001_ $$aGraeven, Ullrich$$b15
000297962 7001_ $$aFenk, Roland$$b16
000297962 7001_ $$aHaenel, Mathias$$b17
000297962 7001_ $$avon Metzler, Ivana$$b18
000297962 7001_ $$00000-0001-9836-7932$$aLindemann, Hans-Walter$$b19
000297962 7001_ $$00009-0007-6539-226X$$aScheid, Christof$$b20
000297962 7001_ $$aBlau, Igor-Wolfgang W$$b21
000297962 7001_ $$aSalwender, Hans J$$b22
000297962 7001_ $$aNoppeney, Richard$$b23
000297962 7001_ $$aBesemer, Britta$$b24
000297962 7001_ $$aWeisel, Katja C$$b25
000297962 7001_ $$aGoldschmidt, Hartmut$$b26
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