A Study of Daratumumab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Phase 1 Completed 9 enrolled Janssen Pharmaceutical K.K.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the tolerability and safety of Daratumumab in Japanese participants with relapsed (the return of a medical problem) or refractory (not responding to treatment) multiple myeloma (cancer of plasma cells in bone marrow, characterized by the presence of abnormal proteins in the blood).

Timeline

Start: 2014-04
Primary completion: 2015-09
Completion: 2015-09

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daratumumab	Monoclonal antibody	8 mg/kg	Intravenous
Subject	Daratumumab	Monoclonal antibody	16 mg/kg	Intravenous

A Study of Daratumumab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Summary

Timeline

Publications

Drugs

Indications