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Published in: International Journal of Hematology 4/2018

01-04-2018 | Original Article

Safety and efficacy of daratumumab in combination with bortezomib and dexamethasone in Japanese patients with relapsed or refractory multiple myeloma

Authors: Shinsuke Iida, Tatsuo Ichinohe, Atsushi Shinagawa, Kenshi Suzuki, Naoki Takezako, Masayuki Aoki

Published in: International Journal of Hematology | Issue 4/2018

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Abstract

Daratumumab in combination with bortezomib and dexamethasone (DVd) has demonstrated longer progression-free survival than combination of bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM). In this multicenter, open-label, phase-1 study, the safety, efficacy, and pharmacokinetics (PK) of DVd were evaluated in Japanese patients with RRMM. Eight patients with RRMM aged between 54 and 82 years were enrolled and treated with DVd regimen. Primary endpoints were tolerability and safety. Secondary endpoints were overall response rate (ORR), very good partial response (VGPR) or better, complete response (CR) or better, time to response (TTR), PK, and immunogenicity. All patients (n = 8) experienced Grade ≥ 3 treatment-emergent adverse events (TEAE), with thrombocytopenia (n = 6, 75%) being the most frequent. Mild Grade ≤ 2 infusion-related reactions were reported in five patients. Serious TEAEs were herpes zoster, nasopharyngitis, and prostate cancer (n = 1 each). Three dose-limiting toxicities were observed in two patients. No death or disease progression was reported as of the study cut-off date. ORR was 100% (2 CRs or better, 2 VGPRs, 4 PRs). The median TTR was 0.9 months. PK profiles were comparable to previous studies. The DVd regimen showed acceptable safety with favorable efficacy in Japanese patients with RRMM.

Clinical trial registration number

NCT02497378.
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Metadata
Title
Safety and efficacy of daratumumab in combination with bortezomib and dexamethasone in Japanese patients with relapsed or refractory multiple myeloma
Authors
Shinsuke Iida
Tatsuo Ichinohe
Atsushi Shinagawa
Kenshi Suzuki
Naoki Takezako
Masayuki Aoki
Publication date
01-04-2018
Publisher
Springer Japan
Published in
International Journal of Hematology / Issue 4/2018
Print ISSN: 0925-5710
Electronic ISSN: 1865-3774
DOI
https://doi.org/10.1007/s12185-017-2390-2

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