TY - JOUR
T1 - Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma
T2 - Three-year Follow-up of CASTOR
AU - Mateos, Maria Victoria
AU - Sonneveld, Pieter
AU - Hungria, Vania
AU - Nooka, Ajay K.
AU - Estell, Jane A.
AU - Barreto, Wolney
AU - Corradini, Paolo
AU - Min, Chang Ki
AU - Medvedova, Eva
AU - Weisel, Katja
AU - Chiu, Christopher
AU - Schecter, Jordan M.
AU - Amin, Himal
AU - Qin, Xiang
AU - Ukropec, Jon
AU - Kobos, Rachel
AU - Spencer, Andrew
N1 - Funding Information:
M.-V. Mateos consulted for Janssen, Celgene, GlaxoSmithKline, AbbVie, Takeda, and Amgen; received honoraria from Janssen, Celgene, Takeda, and Amgen; and served on advisory committees for Celgene, Janssen, Takeda, Amgen, GlaxoSmithKline, Oncopeptides AB, and AbbVie. P. Sonneveld received honoraria and research funding from Amgen, Celgene, Janssen, Karyopharm, and Bristol-Myers Squibb. V. Hungria received honoraria from Amgen, Celgene, Janssen, and Takeda. A.K. Nooka consulted and served on advisory committees for Spectrum Pharmaceuticals, Bristol-Myers Squibb, Adaptive Technologies, Amgen, Celgene, Takeda, GlaxoSmithKline, and Janssen. J.A. Estell served on advisory committees for Janssen and Celgene. P. Corradini served on advisory boards for Celgene, Roche, Takeda, Sanofi, AbbVie, Amgen, Gilead, Sandoz, and Novartis; and served as a lecturer for Celgene, Janssen, Roche, Takeda, Sanofi, AbbVie, and Novartis. K. Weisel consulted and served on advisory committees for Amgen, Bristol-Myers Squibb, Celgene, Janssen, Juno, Sanofi, and Takeda; received research funding from Amgen, Celgene, Janssen, and Sanofi; and received honoraria from Amgen, Bristol-Myers Squibb, Celgene, Janssen, and Takeda. C. Chiu, J.M. Schecter, H. Amin, X. Qin, J. Ukropec, and R. Kobos are employees of Janssen. J.M. Schecter holds equity in Johnson & Johnson. A. Spencer received research funding from Celgene, Janssen-Cilag, Amgen, Bristol-Myers Squibb, and Takeda; received honoraria from Celgene, Janssen-Cilag, Amgen, Takeda, and STA; and served on speakers bureaus for Celgene, Janssen-Cilag, and Takeda. The remaining authors have stated that they have no conflicts of interest.This study was sponsored by Janssen Research & Development, LLC. The authors thank the patients who participated in the CASTOR study and their families, as well as the study co-investigators, research nurses, and coordinators at each of the clinical sites. Medical writing and editorial support were provided by Elise Blankenship, PhD, of MedErgy and were funded by Janssen Global Services, LLC. The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at http://yoda.yale.edu.
Funding Information:
This study was sponsored by Janssen Research & Development , LLC. The authors thank the patients who participated in the CASTOR study and their families, as well as the study co-investigators, research nurses, and coordinators at each of the clinical sites. Medical writing and editorial support were provided by Elise Blankenship, PhD, of MedErgy and were funded by Janssen Global Services , LLC. The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinical-trials/transparency . As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at http://yoda.yale.edu .
Publisher Copyright:
© 2019 Janssen Global Services, LLC
PY - 2020/8
Y1 - 2020/8
N2 - 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.
AB - 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.
KW - Clinical trial
KW - Efficacy
KW - Minimal residual disease
KW - Relapsed/refractory
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=85085620818&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85085620818&partnerID=8YFLogxK
U2 - 10.1016/j.clml.2019.09.623
DO - 10.1016/j.clml.2019.09.623
M3 - Article
C2 - 32482541
AN - SCOPUS:85085620818
SN - 2152-2650
VL - 20
SP - 509
EP - 518
JO - Clinical Lymphoma, Myeloma and Leukemia
JF - Clinical Lymphoma, Myeloma and Leukemia
IS - 8
ER -