Adding daratumumab to bortezomib and dexamethasone prolonged progression-free survival, in contrast with bortezomib and dexamethasone alone, for patients with relapsed or relapsed and refractory multiple myeloma, according to a study published in The New England Journal of Medicine.1
For this phase 3 trial, investigators enrolled 498 patients with relapsed or relapsed and refractory multiple myeloma and randomly assigned them to receive bortezomib and dexamethasone alone or with daratumumab.
The 12-month progression-free survival rate was 60.7% in the daratumumab group, in contrast with 26.9% in the control arm.
With a median follow-up of 7.4 months, median progression-free survival was not reach for daratumumab-treated patients, and was 7.2 months in the bortezomib and dexamethasone alone group, corresponding to a 61% reduction in the risk of progression or death with daratumumab (hazard ratio, 0.39; 95% CI, 0.28-0.53; P < .001).
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The overall response rate was also higher in daratumumab arm versus the control arm (82.9% versus 63.2%; P < .001), as were the rates of complete response or better (P = .001) and very good partial response or better (P = .001).
Infusion-related reactions were reported among 45.3% of patients treated with daratumumab, with most being grade 1 or 2, and occurring during the first infusion.
- Palumbo A, Chanan-Khan A, Weisel K, et al. Daratumumab, bortezomib, and dexamethasone for multiple myeloma. N Engl J Med. 2016; 375:754-766.