International Journal of Hematology

, Volume 107, Issue 4, pp 460–467 | Cite as

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

  • Shinsuke Iida
  • Tatsuo Ichinohe
  • Atsushi Shinagawa
  • Kenshi Suzuki
  • Naoki Takezako
  • Masayuki Aoki
Original Article

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.

Keywords

Daratumumab Efficacy Multiple myeloma Safety Tolerability 

Notes

Author contributions

Dr. Aoki had primary role in the study design, analysis and data interpretation. Drs Iida, Ichinohe, Shinagawa, Suzuki and Takezako were involved in study design, data interpretation and also involved as investigators. All authors contributed to the development of the manuscript and approved the final manuscript for submission. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Supplementary material

12185_2017_2390_MOESM1_ESM.docx (17 kb)
Supplementary material 1 (DOCX 16 kb)

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Copyright information

© The Japanese Society of Hematology 2017

Authors and Affiliations

  • Shinsuke Iida
    • 1
  • Tatsuo Ichinohe
    • 2
  • Atsushi Shinagawa
    • 3
  • Kenshi Suzuki
    • 4
  • Naoki Takezako
    • 5
  • Masayuki Aoki
    • 6
  1. 1.Department of Hematology and OncologyNagoya City University Graduate School of Medical SciencesNagoyaJapan
  2. 2.Department of Hematology and Oncology, Research Institute for Radiation Biology and MedicineHiroshima UniversityHiroshimaJapan
  3. 3.Hitachi General HospitalHitachiJapan
  4. 4.Department of HematologyJapanese Red Cross Medical CenterTokyoJapan
  5. 5.Department of HematologyNational Disaster Medical Center of JapanTokyoJapan
  6. 6.Janssen Pharmaceutical K.K.TokyoJapan

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