Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis of CASTOR based
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(2020) 13:115
RESEARCH
Open Access
Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis of CASTOR based on cytogenetic risk Katja Weisel1*, Andrew Spencer2, Suzanne Lentzsch3, Hervé Avet-Loiseau4, Tomer M. Mark5, Ivan Spicka6, Tamas Masszi7, Birgitta Lauri8, Mark-David Levin9, Alberto Bosi10, Vania Hungria11, Michele Cavo12, Je-Jung Lee13, Ajay Nooka14, Hang Quach15, Markus Munder16, Cindy Lee17, Wolney Barreto18, Paolo Corradini19, Chang-Ki Min20, Asher A. Chanan-Khan21, Noemi Horvath17, Marcelo Capra22, Meral Beksac23, Roberto Ovilla24, Jae-Cheol Jo25, Ho-Jin Shin26, Pieter Sonneveld27, Tineke Casneuf28, Nikki DeAngelis29, Himal Amin30, Jon Ukropec31, Rachel Kobos30 and Maria-Victoria Mateos32
Abstract Background: Multiple myeloma (MM) patients with high cytogenetic risk have poor outcomes. In CASTOR, daratumumab plus bortezomib/dexamethasone (D-Vd) prolonged progression-free survival (PFS) versus bortezomib/dexamethasone (Vd) alone and exhibited tolerability in patients with relapsed or refractory MM (RRMM). Methods: This subgroup analysis evaluated D-Vd versus Vd in CASTOR based on cytogenetic risk, determined using fluorescence in situ hybridization and/or karyotype testing performed locally. High-risk patients had t(4;14), t(14;16), and/or del17p abnormalities. Minimal residual disease (MRD; 10−5 sensitivity threshold) was assessed via the clonoSEQ® assay V2.0. Of the 498 patients randomized, 40 (16%) in the D-Vd group and 35 (14%) in the Vd group were categorized as high risk. Results: After a median follow-up of 40.0 months, D-Vd prolonged median PFS versus Vd in patients with standard (16.6 vs 6.6 months; HR, 0.26; 95% CI, 0.19-0.37; P < 0.0001) and high (12.6 vs 6.2 months; HR, 0.41; 95% CI, 0.21–0.83; P = 0.0106) cytogenetic risk. D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk. The safety profile was consistent with the overall population of CASTOR. Conclusion: These updated data reinforce the effectiveness and tolerability of daratumumab-based regimens for RRMM, regardless of cytogenetic risk status. Trial registration: ClinicalTrials.gov, NCT02136134. Registered 12 May 2014 Keywords: Clinical trials, Multiple myeloma, Myeloma therapy
* Correspondence: [email protected] 1 Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's
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