Purpose of this Study
We are doing this study to find out if an experimental drug called iberdomide (the study drug) is a safe and effective option for multiple myeloma (MM). We also want to what the most appropriate dose and timing for taking the study drug should be.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Have multiple myeloma that is not responding to therapy; OR</li>
<li>Have multiple myeloma that has come back after previous therapy</li></ul>
For more information about who can join this study, please contact the study team 919-668-0613.
<li>Have multiple myeloma that is not responding to therapy; OR</li>
<li>Have multiple myeloma that has come back after previous therapy</li></ul>
For more information about who can join this study, please contact the study team 919-668-0613.
What is Involved?
This study has three periods: a screening period, the study drug period, and a follow-up period.
If you choose to join this study, during the screening period you will:<ul>
<li>Have a physical exam</li>
<li>Have blood draws</li>
<li>Give urine samples</li>
<li>Have imaging tests (X-Ray, MRI/CT/PET scans)</li>
<li>Have a bone marrow biopsy</li></ul>
You will proceed to the study drug period if you are eligible after screening.
This study will have 2 stages. The stage in which you participate will depend on when you join the study.
If you participate in Stage 1, you will get a random assignment (fair, equal chance) to 1 of 4 different groups:<ul>
<li>Group A1: you will take a regimen of 1 mg of the study drug along with the drugs daratumumab and dexamethasone</li>
<li>Group A2: you will take a regimen of 1.3 mg of the study drug along with the drugs daratumumab and dexamethasone</li>
<li>Group A3: you will take a regimen of 1.6 mg of the study drug along with the drugs daratumumab and dexamethasone</li>
<li>Group B: you will take a regimen of bortezomib, daratumumab, and dexamethasone (standard MM treatment)</li></ul>
If you participate in Stage 2, you will get a random assignment (fair, equal chance) to 1 of 2 different groups:<ul>
<li>Group A: you will take a regimen of the study drug along with the drugs daratumumab and dexamethasone</li>
<li>Group B: you will take a regimen of bortezomib, daratumumab, and dexamethasone</li></ul>
The dose level of the study drug for people who are in Group A for Stage 2 of the study will be decided by the results of Stage 1.
If you choose to join this study, during the screening period you will:<ul>
<li>Have a physical exam</li>
<li>Have blood draws</li>
<li>Give urine samples</li>
<li>Have imaging tests (X-Ray, MRI/CT/PET scans)</li>
<li>Have a bone marrow biopsy</li></ul>
You will proceed to the study drug period if you are eligible after screening.
This study will have 2 stages. The stage in which you participate will depend on when you join the study.
If you participate in Stage 1, you will get a random assignment (fair, equal chance) to 1 of 4 different groups:<ul>
<li>Group A1: you will take a regimen of 1 mg of the study drug along with the drugs daratumumab and dexamethasone</li>
<li>Group A2: you will take a regimen of 1.3 mg of the study drug along with the drugs daratumumab and dexamethasone</li>
<li>Group A3: you will take a regimen of 1.6 mg of the study drug along with the drugs daratumumab and dexamethasone</li>
<li>Group B: you will take a regimen of bortezomib, daratumumab, and dexamethasone (standard MM treatment)</li></ul>
If you participate in Stage 2, you will get a random assignment (fair, equal chance) to 1 of 2 different groups:<ul>
<li>Group A: you will take a regimen of the study drug along with the drugs daratumumab and dexamethasone</li>
<li>Group B: you will take a regimen of bortezomib, daratumumab, and dexamethasone</li></ul>
The dose level of the study drug for people who are in Group A for Stage 2 of the study will be decided by the results of Stage 1.
Study Details
Full Title
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)
Principal Investigator
Cristina
Gasparetto
Protocol Number
PRO00111593
NCT ID
NCT04975997
Phase
III
Enrollment Status
Open to Enrollment