1. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma: Three-year Follow-up of CASTOR
- Author
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Mateos, M.V., Sonneveld, P. (Pieter), Hungria, V., Nooka, A.K. (Ajay), Estell, J.A. (Jane A.), Barreto, W. (Wolney), Corradini, P. (P.), Min, C.-K. (Chang-Ki), Medvedova, E. (Eva), Weisel, K. (Katja), Chiu, C. (Christopher), Schecter, J. (Jordan), Amin, H. (Himal), Qin, X. (Xiang), Ukropec, J. (Jon), Kobos, R. (Rachel), Spencer, A. (Andrew), Mateos, M.V., Sonneveld, P. (Pieter), Hungria, V., Nooka, A.K. (Ajay), Estell, J.A. (Jane A.), Barreto, W. (Wolney), Corradini, P. (P.), Min, C.-K. (Chang-Ki), Medvedova, E. (Eva), Weisel, K. (Katja), Chiu, C. (Christopher), Schecter, J. (Jordan), Amin, H. (Himal), Qin, X. (Xiang), Ukropec, J. (Jon), Kobos, R. (Rachel), and Spencer, A. (Andrew)
- Abstract
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/m2) 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% had 1 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; 95% confidence interval [CI], 0.25-0.40; P < .0001) and the 1PL subgroup (27.0 vs. 7.9 months; HR, 0.22; 95% CI, 0.15-0.32; P < .0001). In lenalidomide-refractory patients, the median PFS was 7.8 versus 4.9 months (HR, 0.44; 95% CI, 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% vs. 2%; 1PL: 20% vs. 3%; both P < .0001). PFS2 was significantly prolonged with D-Vd versus Vd (ITT: HR, 0.48; 95% CI, 0.38-0.61; 1PL: HR, 0.35; 95% CI, 0.24-0.51; P < .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.CASTOR showed the significant clinical benefit of daratumumab plus bortezomib and dexamethasone for patients with previously treated multiple myeloma. With ∼3 years median follow-up, this regimen continues to demonstrate significantly improved progression-free survival with higher minimal residual dise
- Published
- 2019
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