A Study of JNJ-54767414 (Daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Phase 1 Completed 8 enrolled Janssen Pharmaceutical K.K.

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the tolerability and safety of JNJ-54767414 (daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese participants with relapsed (the return of a medical problem) or refractory (not responding to treatment) multiple myeloma.

Timeline

Start: 2015-07-10
Primary completion: 2018-03-06
Completion: 2018-03-06

Publications

Iida S, Ichinohe T, Shinagawa A, Suzuki K, Takezako N, Aoki M. Safety and efficacy of daratumumab in combination with bortezomib and dexamethasone in Japanese patients with relapsed or refractory multiple myeloma. Int J Hematol. 2018 Apr;107(4):460-467. doi: 10.1007/s12185-017-2390-2. Epub 2017 Dec 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daratumumab	Monoclonal antibody	16 mg/kg	Intravenous
Background	Bortezomib	Small molecule	1.3 mg/m2	Subcutaneous
Background	Dexamethasone	Small molecule	20 mg	Oral

A Study of JNJ-54767414 (Daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Summary

Timeline

Publications

Drugs

Indications