What's the purpose of this trial?
The goal of this clinical trial is to find the optimal dose of investigational drug iberdomide in combination with daratumumab and dexamethasone, and to study whether investigational drug iberdomide works in treating relapsed or refractory multiple myeloma when combined with daratumumab and dexamethasone.
This trial is currently open and accepting patients.
What will happen during the trial?
STAGE 1
Participants in this stage will be randomly assigned into one of four groups. Three of the groups will receive different doses of investigational drug Iberdomide in combination with Daratumumab and Dexamethasone. One group will receive comparator combination of Daratumumab, Bortezomib, and Dexamethasone. The three Iberdomide groups will receive different doses of investigational drug Iberdomide.
STAGE 2
Participants in this stage will be randomized into one of two groups. Group A will receive investigational drug Iberdomide (at the dose selected by stage 1), Daratumumab, and Dexamethasone. Group B will receive the comparator combination of Daratumumab, Bortezomib, and Dexamethasone.
You may be able to join this trial if you:
The following criteria is a partial list of reasons why patients may be
eligible to participate in this clinical trial. Further evaluation with a medical professional is
required.
- have measurable disease as defined by the trial criteria.
- have received one to two prior lines of anti-myeloma therapy.
- have achieved a partial response or better to at least one prior anti-myeloma regimen.
- have not previously received treatment with a CD-38 directed therapy (for Stage 1 participants). For Stage 2 participants, previous CD-38 therapy is allowed if while receiving it you:
- achieved at least a partial response,
- your myeloma did not progress while receiving it,
- and your last dose of Daratumumab was more than three months prior to joining the study.
- Previous treatment with Bortezomib is allowed as long as you:
- achieved at least a minimal response, and
- you did not progress while receiving Bortezomib or within 60 days of your last dose.
- do not have central nervous system involvement of your myeloma.
- have not previously received treatment with investigational drug Iberdomide.
- have not previously received an allogeneic stem cell transplant, and have not received an autologous stem cell transplant in the last three months.
- have adequate bone marrow, liver, cardiac and lung function as described in the trial criteria.
Additional eligibility criteria apply and can be explained by the study doctor.
Additional Trial Information
Phase 3
Enrollment: 864 patients (estimated)
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