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Adding Daratumumab to Lenalidomide-Dexamethasone in MM
N Engl J Med; 2016 Oct 6; Dimopoulos, Oriol, et al
Adding daratumumab to lenalidomide and dexamethasone improved progression-free survival among patients with relapsed or refractory multiple myeloma, according to a phase 3 randomized trial involving 569 individuals.
Investigators randomly assigned participants—all of whom had multiple myeloma and had been given 1 or more previous lines of therapy—to receive lenalidomide and dexamethasone either alone (n=286) or combined with daratumumab (n=283). Among the results:
- At a median follow-up of 13.5 months, disease progression or death occurred in ~2 in every 10 patients in the combination group, vs 4 in every 10 in the lenalidomide/dexamethasone-alone group.
- Progression-free survival rate at 12 months was 83% in the combination group, vs 60% in the lenalidomide/dexamethasone-alone contingent.
- Overall response was achieved in 93% of the combination group, vs ~three-fourths in the lenalidomide/dexamethasone-alone cohort.
- Complete response rate or better was 43% and 19%, respectively.
- Neutropenia occurred in ~half of patients in the combination group, vs 37% of those in the lenalidomide/dexamethasone-alone group.
Citation:
Dimopoulos M, Oriol A, Nahi H, et al. Daratumumab, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375(14):1319-1331. doi:10.1056/NEJMoa1607751.