Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma: Three-year Follow-up of CASTOR

Maria Victoria Mateos, Pieter Sonneveld, Vania Hungria, Ajay K. Nooka, Jane A. Estell, Wolney Barreto, Paolo Corradini, Chang Ki Min, Eva Medvedova, Katja Weisel, Christopher Chiu, Jordan M. Schecter, Himal Amin, Xiang Qin, Jon Ukropec, Rachel Kobos, Andrew Spencer

Research output: Contribution to journalArticlepeer-review

11 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)509-518
Number of pages10
JournalClinical Lymphoma, Myeloma and Leukemia
Volume20
Issue number8
DOIs
StatePublished - Aug 2020

Keywords

  • Clinical trial
  • Efficacy
  • Minimal residual disease
  • Relapsed/refractory
  • Safety

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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