BACKGROUND: In the phase III CASTOR study in relapsed or refractory multiple myeloma, daratumumab, bortezomib, and dexamethasone (D-Vd) demonstrated significant clinical benefit versus Vd alone. Outcomes after 40.0 months of median follow-up are discussed. PATIENTS AND METHODS: Eligible patients had received ≥ 1 line of treatment and were administered bortezomib (1.3 mg/m(2)) and dexamethasone (20 mg) for 8 cycles with or without daratumumab (16 mg/kg) until disease progression. RESULTS: Of 498 patients in the intent-to-treat (ITT) population (D-Vd, n = 251; Vd, n = 247), 47 prior line of treatment (1PL; D-Vd, n = 122; Vd, n = 113). Median progression-free survival (PFS) was significantly prolonged with D-Vd versus Vd in the ITT population (16.7 vs. 7.1 months; hazard ratio [HR], 0.31; 95CI], 0.25-0.40; P textless .0001) and the 1PL subgroup (27.0 vs. 7.9 months; HR, 0.22; 95 0.15-0.32; P textless .0001). In lenalidomide-refractory patients, the median PFS was 7.8 versus 4.9 months (HR, 0.44; 95 0.28-0.68; P = .0002) for D-Vd (n = 60) versus Vd (n = 81). Minimal residual disease (MRD)-negativity rates (10(-5)) were greater with D-Vd versus Vd (ITT: 14 1PL: 20 both P textless .0001). PFS2 was significantly prolonged with D-Vd versus Vd (ITT: HR, 0.48; 95 0.38-0.61; 1PL: HR, 0.35; 95 0.24-0.51; P textless .0001). No new safety concerns were observed. CONCLUSION: After 3 years, D-Vd maintained significant benefits in patients with relapsed or refractory multiple myeloma with a consistent safety profile. D-Vd provided the greatest benefit at first relapse and increased MRD-negativity rates.
- *Clinical trial
- *Minimal residual disease