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NCT02626481: IFM2014-04

Study of Daratumumab in Combination With Dexamethasone in Resistant or Refractory Multiple Myeloma

Completed Phase 2 Last updated 7 April 2026
What this trial tests

Phase 2 trial testing Daratumumab in Multiple Myeloma in 64 participants. Completed in 9 March 2020.

Timeline
28 December 2015
Primary endpoint
9 March 2020
9 March 2020

Quick facts

Lead sponsorUniversity Hospital, Lille
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment64
Start date28 December 2015
Primary completion9 March 2020
Estimated completion9 March 2020
Sites41 locations across Belgium, France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Lille

Who can join

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

Sponsor's own description

This study is a Multicentre, Open-label, Phase II study of Daratumumab and Dexamethasone in MM patients. Eligible patients must have a symptomatic RRMM with a measurable disease, resistant or refractory to Bortezomib and Lenalidomide and Pomalidomide. There is no dose escalation phase, as the MAxiamal Tolerated Dose (MTD) and drug scheduling have already been determined in previous phase 1-2 dose escalation studies. There is no randomization.

Publications & conference data

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

  1. 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
  2. Disruption of the NKG2A:HLA-E Immune Checkpoint Axis to Enhance NK Cell Activation against Cancer.
    Fisher JG, Doyle ADP, Graham LV, Khakoo SI, et al · · 2022 · cited 47× · PMID 36560403 · DOI 10.3390/vaccines10121993
  3. Monoclonal Antibodies for the Treatment of Multiple Myeloma: An Update.
    Abramson HN. · · 2018 · cited 42× · PMID 30544512 · DOI 10.3390/ijms19123924
  4. Managing Cancer Drug Resistance from the Perspective of Inflammation.
    Lu S, Li Y, Zhu C, Wang W, et al · · 2022 · cited 17× · PMID 36245983 · DOI 10.1155/2022/3426407
  5. Immunotherapy of Multiple Myeloma: Promise and Challenges.
    Abramson HN. · · 2021 · cited 12× · PMID 34527606 · DOI 10.2147/itt.s306103

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 University Hospital, Lille trials

Trials by the same sponsor.

Verify against primary sources

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/NCT02626481.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing