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NCT03234972

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

Completed Phase 3 Last updated 29 May 2024
What this trial tests

Phase 3 trial testing Daratumumab in Multiple Myeloma in 213 participants. Completed in 27 February 2024.

Timeline
30 November 2017
Primary endpoint
7 October 2019
27 February 2024

Quick facts

Lead sponsorJanssen Research & Development, LLC
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment213
Start date30 November 2017
Primary completion7 October 2019
Estimated completion27 February 2024
Sites27 locations across China, Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Rare Genetic Diseases with Defects in DNA Repair: Opportunities and Challenges in Orphan Drug Development for Targeted Cancer Therapy.
    Bhattacharjee S, Nandi S. · · 2018 · cited 34× · PMID 30200453 · DOI 10.3390/cancers10090298
  2. Addition of daratumumab to multiple myeloma backbone regimens significantly improves clinical outcomes: a systematic review and meta-analysis of randomised controlled trials.
    Kiss S, Gede N, Hegyi P, Nagy B, et al · · 2021 · cited 16× · PMID 34754015 · DOI 10.1038/s41598-021-01440-x
  3. Contemporary patient-tailored treatment strategies against high risk and relapsed or refractory multiple myeloma.
    Uckun FM, Qazi S, Demirer T, Champlin RE. · · 2019 · cited 15× · PMID 30545798 · DOI 10.1016/j.ebiom.2018.12.004
  4. Efficacy and safety of daratumumab in the treatment of relapsed/refractory multiple myeloma: A meta-analysis of randomized controlled trials.
    Huang ZY, Jin XQ, Liang QL, Zhang DY, et al · · 2023 · cited 2× · PMID 37747011 · DOI 10.1097/md.0000000000035319
  5. Outcomes in patients with relapsed/refractory multiple myeloma with extramedullary disease: a meta-analysis.
    Voorhees PM, Kumar S, Usmani SZ, Ye JC, et al · · 2025 · cited 1× · PMID 41335212 · DOI 10.1007/s00277-025-06705-3
  6. Potential surrogate endpoint for B-cell hematologic malignancy: A systematic review and meta-analysis.
    Hirano S, Hanada K, Maeda H. · · 2025 · PMID 40456850 · DOI 10.1038/s41598-025-05053-6
  7. Survival trends using DPd vs. other triplets in early RRMM patients: a population-adjusted indirect treatment comparison.
    Anwer F, Lan T, Dolph M, Moradian H, et al · · 2025 · PMID 39611661 · DOI 10.1080/14796694.2024.2426443
  8. Abstract Book for the 27th Congress of the European Hematology Association
    · 2022

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Other trials of Daratumumab

Trials testing the same drug.

Other recruiting trials for Multiple Myeloma

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Other Janssen Research & Development, LLC trials

Trials by the same sponsor.

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Data sources for this page

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