Baertsch Marc-Andrea, Schlenzka Jana, Hielscher Thomas, Raab Marc S, Sauer Sandra, Merz Maximilian, Mai Elias Karl, Müller-Tidow Carsten, Luntz Steffen, Jauch Anna, Brossart Peter, Goerner Martin, Klein Stefan, Glass Bertram, Reimer Peter, Graeven Ullrich, Fenk Roland, Haenel Mathias, von Metzler Ivana, Lindemann Hans W, Scheid Christof, Blau Igor-Wolfgang, Salwender Hans J, Noppeney Richard, Besemer Britta, Weisel Katja C, Goldschmidt Hartmut
Heidelberg Myeloma Center and GMMG Study Group, Department of Medicine V, Heidelberg University Hospital and Medical Faculty Heidelberg, Heidelberg, Germany.
Clinical Cooperation Unit Molecular Hematology/Oncology, German Cancer Research Center, Heidelberg, Germany.
Blood. 2025 Apr 17;145(16):1780-1787. doi: 10.1182/blood.2024027342.
The multicenter, phase 3 German-Speaking Myeloma Multicenter Group (GMMG) ReLApsE trial randomized patients with relapsed and/or refractory multiple myeloma (RRMM) equally to lenalidomide/dexamethasone (LEN/DEX; 25 mg days 1-21, DEX 40 mg weekly, in 4-week cycles) reinduction, salvage high-dose chemotherapy (sHDCT; melphalan 200 mg/m2), autologous stem cell transplantation (ASCT), and LEN maintenance (10 mg/d; transplant arm, n = 139) vs continuous LEN/DEX (control arm, n = 138). Ninety-four percent of patients had received frontline HDCT/ASCT. We report an updated analysis of survival end points 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 (hazard ratio [HR], 0.98; P = .9). Median overall survival (OS) was 67.1 and 62.7 months, respectively, (HR 0.89; P = .44). Landmark analyses from sHDCT and the contemporaneous LEN/DEX cycle 5 were performed because of 29% dropout of patients before sHDCT/ASCT in the transplant arm but did not reveal significant differences in PFS/OS. Time to progression after frontline HDCT/ASCT 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. This trial was registered at www.clinicaltrialsregister.eu as #EudraCT2009-013856-61.
多中心3期德语骨髓瘤多中心组（GMMG）复发试验将复发和/或难治性多发性骨髓瘤（RRMM）患者随机分为两组，一组接受来那度胺/地塞米松（LEN/DEX；第1 - 21天25mg，地塞米松每周40mg，每4周为一个周期）再诱导、挽救性大剂量化疗（sHDCT；美法仑200mg/m²）、自体干细胞移植（ASCT）以及来那度胺维持治疗（10mg/天；移植组，n = 139），另一组接受持续LEN/DEX治疗（对照组，n = 138）。94%的患者接受过一线大剂量化疗/自体干细胞移植。我们报告了生存终点的更新分析，中位随访时间为99个月。移植组和对照组的中位无进展生存期（PFS）分别为20.5个月和19.3个月（风险比[HR]，0.98；P = 0.9）。中位总生存期（OS）分别为67.1个月和62.7个月（HR 0.89；P = 0.44）。由于移植组有29%的患者在sHDCT/ASCT之前退出，因此对sHDCT和同期LEN/DEX第5周期进行了标志性分析，但未发现PFS/OS有显著差异。一线大剂量化疗/自体干细胞移植后的疾病进展时间是一个预后因素，但不能预测sHDCT/ASCT的获益情况。GMMG复发试验不支持在一线大剂量化疗/自体干细胞移植后的RRMM患者中使用sHDCT/ASCT。该试验在www.clinicaltrialsregister.eu上注册，注册号为#EudraCT2009-013856-61。
