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Comparing two treatment combinations for relapsed or refractory multiple myeloma

A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)

Phase 3 Interventional Celgene · NCT04975997

This study is testing if a new combination of medications can work better than the standard treatment for people with relapsed or refractory multiple myeloma.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment864 (estimated)
Ages18 Years and up
SexAll
SponsorCelgene Industry-sponsored
Drugs / interventionsdaratumumab
Locations279 sites (Hot Springs, Arkansas and 278 other locations)
Trial IDNCT04975997 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial is a multicenter, randomized, controlled, open-label study that evaluates the efficacy and safety of iberdomide combined with dexamethasone and daratumumab (IberDd) against a standard treatment of daratumumab, bortezomib, and dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma. The study consists of two stages, with approximately 200 patients in stage 1 receiving different doses of iberdomide, followed by an additional 664 patients in stage 2 randomized to one of the two treatment arms. Participants will be treated until disease progression, unacceptable toxicity, or withdrawal of consent, with ongoing follow-up for disease assessment. The study adheres to international guidelines for clinical trials.

Who should consider this trial

Good fit: Ideal candidates are adults with a documented diagnosis of multiple myeloma who have received 1 to 2 prior lines of therapy and have measurable disease.

Not a fit: Patients with plasma cell leukemia, Waldenstrom's macroglobulinemia, or those who have previously received iberdomide may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with relapsed or refractory multiple myeloma.

How similar studies have performed: Other studies have shown promising results with similar treatment combinations, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

* Documented diagnosis of multiple myeloma (MM) and measurable disease.
* Received 1 to 2 prior lines of anti-myeloma therapy.
* Must have documented disease progression during or after their last anti-myeloma regimen.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.

Exclusion Criteria

* Any condition that confounds the ability to interpret data from the study.
* Has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis.
* Known central nervous system involvement with MM.
* Prior therapy with iberdomide.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where this trial is running

Hot Springs, Arkansas and 278 other locations

+229 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple MyelomaIberdomideCC-220DaratumumabDarzalex FasproBortezomibVelcadeDexamethasone
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.