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

NCT03234972 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2024-05-29

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Daratumumab

Daratumumab will be administered on Day 1 of Cycles 4-9, and then q4w thereafter.

DRUG

Velcade

Velcade will be administered at a dose of 1.3 mg/m\^2 SC on Days 1, 4, 8 and 11 of each 21-day cycle.

DRUG

Dexamethasone

Dex will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 Velcade treatment cycles.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03234972 on ClinicalTrials.gov