drugset / Trial / NCT03242889
A Study of Subcutaneous Delivery of JNJ-54767414 (Daratumumab) in Japanese Participants With Relapsed or Refractory Multiple Myeloma
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the tolerability and safety of subcutaneous (SC) delivery of co-formulated daratumumab and rHuPH20 preparation (DARA SC) in Japanese participants with relapsed or refractory multiple myeloma (MM).
Timeline
- Start
- 2017-08-10
- Primary completion
- 2017-11-01
- Completion
- 2023-02-10
Publications
- Li X, Dosne AG, Perez Ruixo C, Perez Ruixo JJ. Pharmacodynamic-Mediated Drug Disposition (PDMDD) Model of Daratumumab Monotherapy in Patients with Multiple Myeloma. Clin Pharmacokinet. 2023 May;62(5):761-777. doi: 10.1007/s40262-023-01232-8. Epub 2023 Apr 6.
- Shibayama H, Matsumoto M, Kosugi H, Shibayama K, Yamazaki H, Iida S. Subcutaneous delivery of daratumumab in Japanese patients with relapsed/refractory multiple myeloma. Int J Hematol. 2021 Jan;113(1):112-121. doi: 10.1007/s12185-020-02985-9. Epub 2020 Sep 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daratumumab | Monoclonal antibody | 1800 mg | Subcutaneous |
| Background | rHuPH20 | Protein / enzyme biologic | 30000 iu | Subcutaneous |