07-05-2025
Myeloma: Does Salvage Transplant Show Benefit?
After a median follow-up of 99 months, salvage high-dose chemotherapy and autologous stem cell transplantation (sHDCT/ASCT) showed no survival benefit compared with continuous lenalidomide/dexamethasone in relapsed multiple myeloma. The absence of benefit was consistent across all subgroups, including patients with time to progression after frontline transplant beyond 48 months.
METHODOLOGY:
Researchers randomized 277 patients with relapsed and/or refractory multiple myeloma equally to receive either lenalidomide/dexamethasone reinduction followed by sHDCT/ASCT and lenalidomide maintenance or continuous lenalidomide/dexamethasone.
Participants received lenalidomide 25 mg on days 1-21 and dexamethasone 40 mg weekly in 4-week cycles, with the transplant arm receiving melphalan 200 mg/m 2 for sHDCT followed by lenalidomide maintenance at 10 mg daily.
for sHDCT followed by lenalidomide maintenance at 10 mg daily. Analysis included 94% of patients who had received frontline HDCT/ASCT, with 38% having received frontline tandem HDCT/ASCT, and 11% having previous lenalidomide exposure.
TAKEAWAY:
Median progression-free survival was 20.5 months (95% CI, 15.9-27.2) in the transplant arm vs 19.3 months (95% CI, 14.9-25.4) in the control arm (hazard ratio [HR], 0.98; 95% CI, 0.76-1.27; P = .9).
= .9). Overall survival showed no significant difference between arms, with median 67.1 months (95% CI, 59.2-85.4) vs 62.7 months (95% CI, 49.6-86.0) for the transplant arm vs the control arm (HR, 0.89; 95% CI, 0.66-1.20; P = .44).
= .44). Time to progression after frontline transplant did not predict benefit from salvage transplant, with no significant differences in survival even among patients with progression time beyond 48 months.
A 29% dropout rate was observed in the transplant arm before sHDCT/ASCT, primarily due to disease progression, adverse events, and withdrawal of consent.
IN PRACTICE:
'The GMMG ReLApsE trial does not support SHDCT/ASCT at relapse after prior frontline HDCT/ASCT regardless of TTP1,' authors of the study wrote.
SOURCE:
The study was led by Marc-Andrea Baertsch, University Hospital Heidelberg in Heidelberg, Germany. It was published online on April 17 in Blood .
LIMITATIONS:
According to the authors, the interpretation of overall survival outcomes was complicated by the substantial use of posttrial sHDCT/ASCT in the control arm. Additionally, the lenalidomide/dexamethasone reinduction before sHDCT/ASCT may not have been optimal compared with more active triplet regimens.
DISCLOSURES:
The study was supported by the Dietmar Hopp Foundation, Celgene, Chugai, and Amgen. Baertsch reported having relationships with Takeda, Novartis, Sanofi, Stemline, Celgene, Amgen, and Janssen.
