Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
18 Years and older, Male and Female
CC-220-MM-002 (primary)
NCI-2021-08518
2020-000431-49
U1111-1260-2872
Summary
This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study
comparing the efficacy and safety of iberdomide in combination with dexamethasone and
daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in
participants with relapsed or refractory multiple myeloma (RRMM).
Objectives
This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study
comparing the efficacy and safety of iberdomide in combination with dexamethasone and
daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in
participants with relapsed or refractory multiple myeloma (RRMM). Approximately 200
patients randomized in stage 1 to one of three iberdomide dose levels of 1, 1.3, or 1.6
mg in combination with daratumumab and dexamethasone (Treatment Arms A1, A2, or A3), or
to the DVd comparator arm (Treatment Arm B).
In Stage 2 of the study, approximately 664 additional subjects will be randomized 1:1
between 2 treatment arms:
- Approximately 332 subjects will be randomized to receive Treatment Arm A (IberDd)
- Approximately 332 subjects will be randomized to receive Treatment Arm B (DVd)
Participants in both treatment arms will continue to receive treatment until confirmed
progressive disease (PD), unacceptable toxicity or withdrawal of consent. To ensure
accuracy and completeness of the primary endpoint assessment of progression-free survival
(PFS), participants who permanently discontinue study treatment for any reason, other
than confirmed PD or withdrawal of consent, will continue to be followed for disease
assessment.
The study will be conducted in compliance with International Council for Harmonisation
(ICH) and Good Clinical Practices (GCPs).
Eligibility
- 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.
Treatment Sites in Georgia
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