Salvage autologous transplant and lenalidomide maintenance vs. lenalidomide/dexamethasone for relapsed multiple myeloma: the randomized GMMG phase III trial ReLApsE
Patients with 1st-3rd relapse of multiple myeloma (n=282)
Intervention
Salvage high-dose chemotherapy and autologous transplant with lenalidomide maintenance (sHDCT/ASCT, n=139)
Comparison
Lenalidomide/dexamethasone (Continuous Rd, n=138)
Outcome
Median progression-free survival (PFS) was 20.7 months in the transplant and 18.8 months in the control arm (HR 0.87). Median overall survival (OS) was not reached in the transplant and 62.7 months in the control arm (HR 0.81). 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 in patients who received sHDCT/ASCT.
Abstract
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/m(2)), 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.
PICO Summary