Mateos MV, et al. - The intent of the authors was to gauge the efficacy of daratumumab plus bortezomib, melphalan, and prednisone for untreated myeloma. This combination therapy led to a lower risk of disease progression or death than the same regimen without daratumumab among patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation. A correlation was disclosed between the daratumumab-containing regimen with more grade 3 or 4 infections.

Methods

• The eligible candidates comprised of 706 patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation.
• They were randomly assigned to receive nine cycles of bortezomib, melphalan, and prednisone either alone (control group) or with daratumumab (daratumumab group) until disease progression.
• Progression-free survival served as the primary end point.

Results

• It was determined that the 18-month progression-free survival rate was 71.6% (95% confidence interval [CI], 65.5 to 76.8) in the daratumumab group and 50.2% (95% CI, 43.2 to 56.7) in the control group (hazard ratio for disease progression or death, 0.50; 95% CI, 0.38 to 0.65; P < 0.001), at a median follow-up of 16.5 months in a prespecified interim analysis.
• In the daratumumab group, the overall response rate was discovered to be 90.9%, as compared with 73.9% in the control group (P < 0.001), and the rate of complete response or better (including stringent complete response) was 42.6%, vs 24.4% (P < 0.001).
• Herein, 22.3% of the patients were negative for minimal residual disease (at a threshold of 1 tumor cell per 105 white cells) in the daratumumab group, compared with 6.2% of those in the control group (P < 0.001).
• The most common adverse events of grade 3 or 4 were divulged to be hematologic: Neutropenia (in 39.9% of the patients in the daratumumab group and in 38.7% of those in the control group), thrombocytopenia (in 34.4% and 37.6%, respectively), and anemia (in 15.9% and 19.8%, respectively).
• In the daratumumab group, the rate of grade 3 or 4 infections was revealed to be 23.1% and 14.7% in the control group.
• The findings also disclosed that the rate of treatment discontinuation due to infections was 0.9% and 1.4%, respectively.
• The occurrence of daratumumab-associated infusion-related reactions was noted in 27.7% of the patients.