International Journal of Hematology

DOI: 10.1007/s12185-017-2390-2 Pages: 460-467

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

1. Nagoya City University Graduate School of Medical Sciences, Department of Hematology and Oncology

2. Hiroshima University, Department of Hematology and Oncology, Research Institute for Radiation Biology and Medicine

3. Hitachi General Hospital

4. Japanese Red Cross Medical Center, Department of Hematology

5. National Disaster Medical Center of Japan, Department of Hematology

6. Janssen Pharmaceutical K.K.

Correspondence to:
Shinsuke Iida
Tel: +81-52-853-8738
Email: iida@med.nagoya-cu.ac.jp

Close

Abstract

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.

To access the full text, please Sign in

If you have institutional access, please click here

Share the Knowledge