Daratumumab with lenalidomide and dexamethasone was superior to lenalidomide plus dexamethasone for progression-free survival of patients with relapsed or refractory multiple myeloma, according to a study presented at the European Hematology Association (EHA) 21st Congress.1
For this phase 3 POLLUX trial, investigators enrolled 569 patients with multiple myeloma who had received at least 1 prior line of therapy. Participants were randomly assigned 1:1 to receive lenalidomide and dexamethasone with or without daratumumab, a human anti-CD38 IgG monoclonal antibody.
With a median follow-up of 13.5 months, results showed that adding daratumumab reduced the risk of progression or death by 63% (hazard ratio, 0.37; 95% CI, 0.27-0.52; P < .0001).
Addition of daratumumab to lenalidomide and dexamethasone also prolonged time to progression (hazard ratio, 0.34; 95% CI, 0.23-0.48; P < .0001) and improved the overall response rate (93% versus 76%; P < .001).
Daratumumab-associated infusion-related reactions, which were reported in nearly half of daratumumab-treated patients, were mostly grade 1 to 2; 92% occurred during the first infusion.
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Similar rates of treatment discontinuation due to treatment-emergent adverse events were observed between the 2 groups.
- Dimopoulos MA, Oriol A, Nahi H, et al. An open-label, randomised phase 3 study of daratumumab, lenalidomide, and dexamethasone (DRd) versus lenalidomide and dexamethasone (Rd) in relapsed or refractory multiple myeloma (RRMM): POLLUX. Paper presented at: European Hematology Association 21st Congress; June 9-12, 2016; Copenhagen, Denmark.