|The following article features coverage from the American Society of Hematology (ASH) 2018 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
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.
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- 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.
This article originally appeared on Cancer Therapy Advisor