drugset / Trial / NCT03217812

A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region)

NCT03217812

Phase 3 Completed 220 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine if the addition of daratumumab to VELCADE-melphalan-prednisone (VMP) will improve very good partial response (VGPR) or better compared with VMP alone.

Timeline

Start
2017-11-23
Primary completion
2020-07-02
Completion
2024-03-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab Monoclonal antibody 16 mg/kg Intravenous
Background Bortezomib Small molecule 1.3 mg/m2 Subcutaneous
Background Melphalan Small molecule 4.5 mg/m2 Oral
Background Melphalan Small molecule 9 mg/m2 Oral
Background Prednisone Other / unclassified 60 mg/m2 Oral

Indications