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NCT02316106

A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma

Completed Phase 2 Last updated 27 April 2025
What this trial tests

Phase 2 trial testing daratumumab in Multiple Myeloma in 123 participants. Completed in 3 June 2024.

Timeline
20 May 2015
Primary endpoint
2 June 2023
3 June 2024

Quick facts

Lead sponsorJanssen Research & Development, LLC
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment123
Start date20 May 2015
Primary completion2 June 2023
Estimated completion3 June 2024
Sites57 locations across France, Netherlands, Russia, United Kingdom, Germany, Israel, Canada, Australia

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 purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.

Publications & conference data

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

  1. Monoclonal antibodies targeting CD38 in hematological malignancies and beyond.
    van de Donk NW, Janmaat ML, Mutis T, Lammerts van Bueren JJ, et al · · 2016 · cited 268× · PMID 26864107 · DOI 10.1111/imr.12389
  2. Daratumumab: a first-in-class CD38 monoclonal antibody for the treatment of multiple myeloma.
    Sanchez L, Wang Y, Siegel DS, Wang ML. · · 2016 · cited 127× · PMID 27363983 · DOI 10.1186/s13045-016-0283-0
  3. Daratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS).
    Landgren CO, Chari A, Cohen YC, Spencer A, et al · · 2020 · cited 65× · PMID 32024950 · DOI 10.1038/s41375-020-0718-z
  4. A look backward and forward in the regulatory and treatment history of multiple myeloma: Approval of novel-novel agents, new drug development, and longer patient survival.
    Kazandjian D, Landgren O. · · 2016 · cited 53× · PMID 28061986 · DOI 10.1053/j.seminoncol.2016.10.008
  5. Monoclonal Antibodies for the Treatment of Multiple Myeloma: An Update.
    Abramson HN. · · 2018 · cited 42× · PMID 30544512 · DOI 10.3390/ijms19123924
  6. Evaluating Daratumumab in the Treatment of Multiple Myeloma: Safety, Efficacy and Place in Therapy.
    Dima D, Dower J, Comenzo RL, Varga C. · · 2020 · cited 36× · PMID 32904669 · DOI 10.2147/cmar.s212526
  7. Pursuing a Curative Approach in Multiple Myeloma: A Review of New Therapeutic Strategies.
    D'Agostino M, Bertamini L, Oliva S, Boccadoro M, et al · · 2019 · cited 32× · PMID 31847174 · DOI 10.3390/cancers11122015
  8. CD38 as Immunotherapeutic Target in Light Chain Amyloidosis and Multiple Myeloma-Association With Molecular Entities, Risk, Survival, and Mechanisms of Upfront Resistance.
    Seckinger A, Hillengass J, Emde M, Beck S, et al · · 2018 · cited 32× · PMID 30079070 · DOI 10.3389/fimmu.2018.01676

Verify or expand the search:

Other trials of daratumumab

Trials testing the same drug.

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

Other Janssen Research & Development, LLC trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02316106.

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