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000157227 1001_ $$aGoldschmidt, Hartmut$$b0
000157227 245__ $$aSalvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE.
000157227 260__ $$aLondon$$bSpringer Nature$$c2021
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000157227 520__ $$aThe role of salvage high-dose chemotherapy and autologous stem cell transplantation (sHDCT/ASCT) for relapsed and/or refractory multiple myeloma (RRMM) in the era of continuous novel agent treatment has not been defined. This randomized, open-label, phase III, multicenter trial randomized patients with 1st-3rd relapse of multiple myeloma (MM) to a transplant arm (n = 139) consisting of 3 Rd (lenalidomide 25 mg, day 1-21; dexamethasone 40 mg, day 1, 8, 15, and 22; 4-week cycles) reinduction cycles, sHDCT (melphalan 200 mg/m2), ASCT, and lenalidomide maintenance (10 mg/day) or to a control arm (n = 138) of continuous Rd. Median PFS was 20.7 months in the transplant and 18.8 months in the control arm (HR 0.87; 95% CI 0.65-1.16; p = 0.34). Median OS was not reached in the transplant and 62.7 months in the control arm (HR 0.81; 95% CI 0.52-1.28; p = 0.37). Forty-one patients (29%) did not receive the assigned sHDCT/ASCT mainly due to early disease progression, adverse events, and withdrawal of consent. Multivariate landmark analyses from the time of sHDCT showed superior PFS and OS (p = 0.0087/0.0057) in patients who received sHDCT/ASCT. Incorporation of sHDCT/ASCT into relapse treatment with Rd was feasible in 71% of patients and did not significantly prolong PFS and OS on ITT analysis while patients who received sHDCT/ASCT may have benefitted.
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000157227 7001_ $$00000-0002-4000-6904$$aBaertsch, Marc-Andrea$$b1
000157227 7001_ $$aSchlenzka, Jana$$b2
000157227 7001_ $$0P:(DE-He78)ecb33fb615e08035fdcefcaebfdff8f0$$aBecker, Natalia$$b3
000157227 7001_ $$0P:(DE-HGF)0$$aHabermehl, Christina$$b4
000157227 7001_ $$0P:(DE-He78)743a4a82daab55306a2c88b9f6bf8c2f$$aHielscher, Thomas$$b5$$udkfz
000157227 7001_ $$0P:(DE-He78)1cb537e833afd985097ccfaddffb2ef3$$aRaab, Marc-Steffen$$b6$$udkfz
000157227 7001_ $$aHillengass, Jens$$b7
000157227 7001_ $$aSauer, Sandra$$b8
000157227 7001_ $$00000-0002-7166-5232$$aMüller-Tidow, Carsten$$b9
000157227 7001_ $$aLuntz, Steffen$$b10
000157227 7001_ $$aJauch, Anna$$b11
000157227 7001_ $$aHose, Dirk$$b12
000157227 7001_ $$aSeckinger, Anja$$b13
000157227 7001_ $$aBrossart, Peter$$b14
000157227 7001_ $$aGoerner, Martin$$b15
000157227 7001_ $$aKlein, Stefan$$b16
000157227 7001_ $$aSchmidt-Hieber, Martin$$b17
000157227 7001_ $$aReimer, Peter$$b18
000157227 7001_ $$aGraeven, Ullrich$$b19
000157227 7001_ $$aFenk, Roland$$b20
000157227 7001_ $$aHaenel, Mathias$$b21
000157227 7001_ $$aMartin, Hans$$b22
000157227 7001_ $$aLindemann, Hans W$$b23
000157227 7001_ $$aScheid, Christoph$$b24
000157227 7001_ $$aNogai, Axel$$b25
000157227 7001_ $$aSalwender, Hans$$b26
000157227 7001_ $$aNoppeney, Richard$$b27
000157227 7001_ $$aBesemer, Britta$$b28
000157227 7001_ $$aWeisel, Katja$$b29
000157227 7001_ $$aGroup, German Myeloma Multicenter$$b30$$eCollaboration Author
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