EXCALIBER-Maintenance

Phase 3 Clinical Trial Comparing Iberdomide VS Lenalidomide as Maintenance Therapy Following Autologous Stem Cell Transplant in Participants with Newly Diagnosed Multiple Myeloma

What will happen during the trial?

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.

More Information

Trial Status
Not currently accepting
Trial Phase
Phase 3
Enrollment
1,216 patients (estimated)
Sponsors
Bristol Myers Squibb
Tags
Cereblon E3 Ligase Modulators (CELMoDs), Randomization
Trial Type
Treatment
Last Update
4 weeks ago
SparkCures ID
1478
NCT Identifier
NCT05827016

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