drugset / Trial / NCT03234972

A Study to Compare Daratumumab, Bortezomib, and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Chinese Participants With Relapsed or Refractory Multiple Myeloma

NCT03234972

Phase 3 Completed 213 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary purpose of this study is to compare the efficacy of daratumumab when combined with Velcade (bortezomib) and dexamethasone (DVd) to that of Velcade and dexamethasone (Vd), in terms of progression free survival (PFS) in Chinese participants with relapsed or refractory multiple myeloma (MM).

Timeline

Start
2017-11-30
Primary completion
2019-10-07
Completion
2024-02-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab Monoclonal antibody 16 mg/kg Intravenous
Background Bortezomib Small molecule 1.3 mg/m2 Subcutaneous
Background Dexamethasone Small molecule 20 mg Oral

Indications