The goal of this clinical trial is to learn more about the safety and efficacy of an investigational drug called Iberdomide when used as maintenance therapy, and to compare its safety and efficacy to Lenalidomide maintenance therapy.
This trial is currently open and accepting patients.
Participation in this study will be randomized, which means the study team will randomly place participants into one of several different groups. This trial is open-label, which means that both researchers and participants will know which groups they are placed in, and which medications and doses they will be receiving.
This trial is organized into two different parts, or stages. In Stage 1, researchers will compare the safety and efficacy of three different dose levels of investigational drug Iberdomide to the standard maintenance treatment of Lenalidomide. Participants in this stage will be randomly assigned into one of four different arms (or groups). Three arms (A1, A2, and A3) will receive one of three different doses of investigational drug Iberdomide. The fourth group will receive Lenalidomide.
In Stage 2, researchers will compare the safety and efficacy of investigational Iberdomide (using the dose from Stage 1) versus Lenalidomide. Participants in this stage will be randomly assigned into one of two different arms (Arms A and B). Participants in either part of the study can continue to receive the treatment they were randomized to as long as their myeloma remains stable or improves, and they don’t experience important side effects.
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 3-6 cycles of induction therapy, including a proteasome inhibitor and immunomodulatory agent (VTD [bortezomib, thalidomide, dexamethasone], RVd [lenalidomide, bortezomib, dexamethasone]) with or without a CD38 monoclonal antibody, or VCd (bortezomib, cyclophosphamide, dexamethasone) and followed by an autologous stem cell transplant. Participants are allowed to have received consolidation therapy after transplant.
• must be within 12 months from start of induction therapy, and have achieved at least a partial response after stem cell transplant.
• do not have known myeloma involvement in the central nervous system.
• have adequate bone marrow, kidney, and liver function.
Enrollment: 1,216 patients (estimated)View More
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