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100 | 1 | _ | |a Goldschmidt, Hartmut |b 0 |
245 | _ | _ | |a Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE. |
260 | _ | _ | |a London |c 2021 |b Springer Nature |
336 | 7 | _ | |a article |2 DRIVER |
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500 | _ | _ | |a 2021 Apr;35(4):1134-1144 |
520 | _ | _ | |a 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/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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700 | 1 | _ | |a Schlenzka, Jana |b 2 |
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700 | 1 | _ | |a Habermehl, Christina |0 P:(DE-HGF)0 |b 4 |
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700 | 1 | _ | |a Hillengass, Jens |b 7 |
700 | 1 | _ | |a Sauer, Sandra |b 8 |
700 | 1 | _ | |a Müller-Tidow, Carsten |0 0000-0002-7166-5232 |b 9 |
700 | 1 | _ | |a Luntz, Steffen |b 10 |
700 | 1 | _ | |a Jauch, Anna |b 11 |
700 | 1 | _ | |a Hose, Dirk |b 12 |
700 | 1 | _ | |a Seckinger, Anja |b 13 |
700 | 1 | _ | |a Brossart, Peter |b 14 |
700 | 1 | _ | |a Goerner, Martin |b 15 |
700 | 1 | _ | |a Klein, Stefan |b 16 |
700 | 1 | _ | |a Schmidt-Hieber, Martin |b 17 |
700 | 1 | _ | |a Reimer, Peter |b 18 |
700 | 1 | _ | |a Graeven, Ullrich |b 19 |
700 | 1 | _ | |a Fenk, Roland |b 20 |
700 | 1 | _ | |a Haenel, Mathias |b 21 |
700 | 1 | _ | |a Martin, Hans |b 22 |
700 | 1 | _ | |a Lindemann, Hans W |b 23 |
700 | 1 | _ | |a Scheid, Christoph |b 24 |
700 | 1 | _ | |a Nogai, Axel |b 25 |
700 | 1 | _ | |a Salwender, Hans |b 26 |
700 | 1 | _ | |a Noppeney, Richard |b 27 |
700 | 1 | _ | |a Besemer, Britta |b 28 |
700 | 1 | _ | |a Weisel, Katja |b 29 |
700 | 1 | _ | |a Group, German Myeloma Multicenter |b 30 |e Collaboration Author |
773 | _ | _ | |a 10.1038/s41375-020-0948-0 |0 PERI:(DE-600)2008023-2 |n 4 |p 1134-1144 |t Leukemia |v 35 |y 2021 |x 1476-5551 |
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