A phase III clinical trial compared treatment with daratumumab, dexamethasone, and lenalidomide against dexamethasone and lenalidomide alone in patients with newly diagnosed multiple myeloma (MM) ineligible for stem-cell transplantation, and reported that the addition of daratumumab increased both overall survival and progression–free survival without introducing new safety concerns. The report was published in The Lancet Oncology.
Lead author, Thierry Falcon, MD, expressed that the findings of the trial “support the frontline use of daratumumab plus lenalidomide and dexamethasone,” in the treatment of patients with the above characteristics.
The trials’ 737 participants were randomly assigned to receive either intravenous daratumumab 16 mg/kg, oral lenalidomide 25 mg, and oral dexamethasone 40 mg or lenalidomide and dexamethasone alone.
At a median follow-up of 56.2 months (interquartile range [IQR] 52.7–59.9), median progression-free survival (PFS) in the daratumumab group was not reached (95% confidence interval [CI], 54.8–not reached), compared to 34.4 months (range: 29.6–39.2) in the control group (hazard ratio [HR] 0.53, 95% CI, 0.43–0.66, p <0.0001).
Grade III adverse events included neutropenia in 197 daratumumab patients versus 135 control patients, pneumonia in 70 patients versus 39 controls, anemia in 61 patients versus 79 controls, and lymphopenia in 60 patients versus 41 controls. Rates of both serious adverse events and treatment-related deaths were similar between the daratumumab and controls groups.
According to the researchers, the results confirmed that combining daratumumab with lenalidomide and dexamethasone in patients with MM who are ineligible for stem-cell transplantation improves clinical outcomes compared to lenalidomide and dexamethasone alone.