/The Role of Salvage Autologous Transplant in the Treatment of Multiple Myeloma

The Role of Salvage Autologous Transplant in the Treatment of Multiple Myeloma

HDCT followed by ASCT for relapsed MM does not significantly improve PFS or OS.
HDCT followed by ASCT for relapsed MM does not significantly improve PFS or OS.

Salvage high-dose chemotherapy (HDCT) followed by autologous stem cell transplantation (ASCT) in patients with relapsed multiple myeloma did not lead to significant difference in progression-free survival (PFS) or overall survival (OS) compared with continuous novel agent-based treatment, according to an oral presentation at the 60th American Society of Hematology (ASH) Annual Meeting in San Diego, California.1

In a randomized, controlled, multicenter phase 3 trial, researchers randomly assigned 277 patients to receive either lenalidomide/dexamethasone (Rd) reinduction, salvage HDCT/ASCT, and lenalidomide (R) maintenance (139 patients; arm B) or standard continuous lenalidomide/dexamethasone (138 patients; arm A). Patients in arm B received three 4-week cycles of Rd (lenalidomide 25 mg on days 1 to 21; dexamethasone 40 mg on days 1, 8, 15, and 22) reinduction, HDCT (melphalan 200 mg/m2), ASCT, and R maintenance (10 mg daily) until progression. Patients in arm A received Rd until progression.

Progression-free survival was the primary outcome of the trial, and OS, response rates, and toxicity were the secondary outcomes.

Overall, 77.9% of patients in arm B and 74.6% of patients in arm A (P =.57) achieved partial response or better, with 49.3% and 47.1% (P =.81), respectively, achieving very good partial response or better. There were 183 PFS events and 76 deaths after a median follow-up of 36.3 months, with median PFS of 20.7 months and 18.8 months (hazard ratio [HR] 0.87; P =.34) in arm B and arm A, respectively. In arm B, median OS was not reached, while median OS was 62.7 months in arm A (HR 0.81; P =.37).

Because 41 patients in arm B did not receive the planned HDCT/ASCT, the researchers conducted exploratory landmark analyses from HDCT in arm B and Rd cycle 5 in arm A. Patients in arm B demonstrated median PFS of 23.3 months and did not reach median OS, compared with median PFS of 20.1 months (HR 0.74; P =.09) and median OS of 57 months (HR .56; P =.046) in arm A. Overall response rate was higher in arm B after HDCT/ASCT as well (82.3% vs 69.6%; P =.04).

Grade 3 or higher adverse events were experienced by 83% of patients in arm B and 74.5% of patients in arm A. While on protocol treatment, 4 patients in arm B and 7 patients in arm A died.

The authors noted that definite conclusions could not be reached because of the number of patients who did not receive salvage HDCT/ASCT, along with the approval of more active Rd-based treatment regimens after the trial had begun.

Read more of Cancer Therapy Advisor‘s coverage of the ASH 2018 meeting by visiting the conference page.


  1. Goldschmidt H, Baertsch M-A, Schlenzka J, et al. Salvage autologous transplant and lenalidomide maintenance versus continuous lenalidomide/dexamethasone for relapsed multiple myeloma: results of the randomized GMMG phase III multicenter trial relapse. Oral presentation at: American Society of Hematology 60th Annual Meeting & Exposition; December 1-4, 2018; San Diego, CA.