HealthDay News — Daratumumab with bortezomib and dexamethasone is associated with longer progression-free survival in patients with relapsed or relapsed and refractory multiple myeloma, according to a study published in the New England Journal of Medicine.
Antonio Palumbo, MD, from the University of Turin in Italy, and colleagues conducted a phase 3 trial involving 498 patients with relapsed or relapsed and refractory multiple myeloma. Participants were randomized to receive bortezomib and dexamethasone alone or in combination with daratumumab.
The researchers found that the rate of progression-free survival was significantly higher in the daratumumab group than the control group in a prespecified interim analysis; the 12-month rate of progression-free survival was 60.7 and 26.9% in the daratumumab and control groups, respectively. The median progression-free survival was not reached in the daratumumab group and was 7.2 months in the control group after a median follow-up period of 7.4 months (hazard ratio, 0.39; P<0.001). The daratumumab group had higher rates of overall response (82.9 versus 63.2%; P<0.001), very good partial response or better (59.2 versus 29.1%; P<0.001), and complete response or better (19.2 versus 9.0%; P=0.001).
“Among patients with relapsed or relapsed and refractory multiple myeloma, daratumumab in combination with bortezomib and dexamethasone resulted in significantly longer progression-free survival than bortezomib and dexamethasone alone,” the authors write.
The study was funded by Janssen Research and Development, the manufacturer of daratumumab.