Study Comparing Two Treatment Combinations for Patients with Relapsed or Refractory Multiple Myeloma
Sponsor: Celgene
ClinicalTrials ID:NCT04975997
This clinical trial is testing two different combinations of medications to see which is more effective and safe for patients with multiple myeloma that has returned or not responded to previous treatments.
Patient Parameters
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Program Overview
The study aims to compare the effectiveness and safety of two treatment combinations for patients with relapsed or refractory multiple myeloma. One group will receive a combination of iberdomide, daratumumab, and dexamethasone (IberDd), while the other group will receive daratumumab, bortezomib, and dexamethasone (DVd).
Description
This clinical trial is being conducted at multiple centers and involves two stages. In the first stage, about 200 patients will be randomly assigned to one of three different doses of iberdomide combined with daratumumab and dexamethasone, or to a comparison group receiving daratumumab, bortezomib, and dexamethasone. In the second stage, around 664 more patients will be randomly assigned to one of the two main treatment groups: either the IberDd group or the DVd group.
Participants will continue their assigned treatment until their disease progresses, they experience unacceptable side effects, or they choose to withdraw from the study. If a participant stops treatment for any reason other than disease progression or withdrawal, they will still be monitored to assess their disease status.
The study follows international guidelines to ensure it is conducted safely and ethically.
Eligibility 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.
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