About this item:

107 Views | 132 Downloads

Author Notes:

Correspondence: aspencer@netspace.net.au

Medical writing and editorial support were provided by Jason Jung, PhD and Kristin Runkle, PhD of MedErgy, and were funded by Janssen Global Services, LLC.

Subjects:

Research Funding:

This study was sponsored by Janssen Research & Development, LLC.

The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinical-trials/transparency.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Hematology
  • MINIMAL RESIDUAL DISEASE
  • LOW-DOSE DEXAMETHASONE
  • OPEN-LABEL
  • INTERGROUPE FRANCOPHONE
  • ANTIBODY DARATUMUMAB
  • TARGETING CD38
  • LENALIDOMIDE
  • POMALIDOMIDE
  • SURVIVAL
  • THERAPY

Daratumumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of CASTOR

Show all authors Show less authors

Tools:

Journal Title:

Haematologica

Volume:

Volume 103, Number 12

Publisher:

, Pages 2079-2087

Type of Work:

Article | Final Publisher PDF

Abstract:

Daratumumab, a CD38 human monoclonal antibody, demonstrated significant clinical activity in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone in the primary analysis of CASTOR, a phase 3 study in relapsed and/or refractory multiple myeloma. A post hoc analysis based on treatment history and longer follow up is presented. After 19.4 (range: 0-27.7) months of median follow up, daratumumab plus bortezomib and dexamethasone prolonged progression-free survival (median: 16.7 versus 7.1 months; ha zard ra ti o, 0.3 1; 95% confidence interval, 0.24 -0.39; P<0.0001) and improved the overall response rate (83.8% versus 63.2%; P<0.0001) compared with bortezomib and dexamethasone alone. The progression-free survival benefit of daratumumab plus bortezomib and dexamethasone was most apparent in patients with 1 prior line of therapy (median: not reached versus 7.9 months; hazard ratio, 0.19; 95% confidence interval, 0.12-0.29; P<0.0001). Daratumumab plus bortezomib and dexamethasone was also superior to bortezomib and dexamethasone alone in subgroups based on prior treatment exposure (bortezomib, thalidomide, or lenalidomide), lenalidomide-refractory status, time since last therapy (≤12, >12, ≤6, or >6 months), or cytogenetic risk. Minimal residual disease–negative rates were >2.5-fold higher with daratumumab across subgroups. The safety profile of daratumumab plus bortezomib and dexamethasone remained consistent with longer follow up. Daratumumab plus bortezomib and dexamethasone demonstrated significant clinical activity across clinically relevant subgroups and provided the greatest benefit to patients treated at first relapse.

Copyright information:

© 2018 Ferrata Storti Foundation.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/).

Creative Commons License

Export to EndNote