Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called iberdomide (the study drug). We want to know how well this study drug works in people with multiple myeloma when compared with a drug called lenalidomide after an autologous stem cell transplant.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with symptomatic MM</li>
<li>Have received an autologous stem cell transplant</li>
<li>Do not have progressive disease or clinical relapse following stem cell transplant</li>
<li>Do not have smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma</li>
<li>Do not have known central nervous system/meningeal involvement of MM</li></ul>
For more information about who can join this study, please contact the study team at 919-668-1026.
<li>Are diagnosed with symptomatic MM</li>
<li>Have received an autologous stem cell transplant</li>
<li>Do not have progressive disease or clinical relapse following stem cell transplant</li>
<li>Do not have smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma</li>
<li>Do not have known central nervous system/meningeal involvement of MM</li></ul>
For more information about who can join this study, please contact the study team at 919-668-1026.
What is Involved?
If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:<ul>
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li>
<li>Provide urine samples</li></ul>
If you are eligible to join the study, you will get a random assignment (like a coin flip) to one of two different groups:<ul>
<li>One group will take a regimen of the study drug</li>
<li>The other group will take a drug call lenalidomide</li></ul>
If you are assigned to the study drug group, you will take the study drug by mouth every day for the first 21 days of each 28-day drug cycle. The dose of the study drug that you get will depend on when you enter the study.
If you are assigned to get lenalidomide, you will take this drug every day. Your dose of lenalidomide will start at 10 mg once daily, and the study doctor might increase this dose to 15 mg after 3 cycles if they believe you will get a benefit from the change.
The total study drug regimen may take up to approximately 4 years, but this can vary depending on how you respond to the study drug.
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li>
<li>Provide urine samples</li></ul>
If you are eligible to join the study, you will get a random assignment (like a coin flip) to one of two different groups:<ul>
<li>One group will take a regimen of the study drug</li>
<li>The other group will take a drug call lenalidomide</li></ul>
If you are assigned to the study drug group, you will take the study drug by mouth every day for the first 21 days of each 28-day drug cycle. The dose of the study drug that you get will depend on when you enter the study.
If you are assigned to get lenalidomide, you will take this drug every day. Your dose of lenalidomide will start at 10 mg once daily, and the study doctor might increase this dose to 15 mg after 3 cycles if they believe you will get a benefit from the change.
The total study drug regimen may take up to approximately 4 years, but this can vary depending on how you respond to the study drug.
Study Details
Full Title
A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy after Autologous Stem Cell Transplantation (ASCT) in Participants with Newly Diagnosed Multiple Myeloma (NDMM)
Principal Investigator
Cristina
Gasparetto
Protocol Number
PRO00113837
NCT ID
NCT05827016
Phase
III
Enrollment Status
Open to Enrollment