Isatuximab + Lenalidomide for Multiple Myeloma
(HEME-18 Trial)
Trial Summary
What is the purpose of this trial?
This is a phase II study where patients will undergo isatuximab and lenalidomide maintenance if they are MRD-positive after Autologous Stem Cell Transplant (ASCT)
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must be willing to take certain blood thinners (like aspirin or warfarin) while receiving lenalidomide.
What data supports the effectiveness of the drug combination Isatuximab and Lenalidomide for treating multiple myeloma?
Research shows that Isatuximab, when combined with other drugs like lenalidomide, can improve the response and delay the progression of multiple myeloma in patients who have tried other treatments. In studies, this combination was generally well tolerated and showed promising results in patients with relapsed or hard-to-treat multiple myeloma.12345
Is the combination of Isatuximab and Lenalidomide safe for treating multiple myeloma?
The combination of Isatuximab and Lenalidomide has been generally well tolerated in clinical trials for multiple myeloma, with manageable side effects. Common side effects include infusion-related reactions, infections, and blood-related issues like low white blood cell counts, but these were mostly mild to moderate in severity.23678
How is the drug Isatuximab + Lenalidomide unique for treating multiple myeloma?
Isatuximab combined with lenalidomide and dexamethasone is unique because it targets the CD38 protein on myeloma cells, enhancing the immune system's ability to fight the cancer. This combination has shown effectiveness in patients who have already tried other treatments, offering a new option for those with relapsed or refractory multiple myeloma.23679
Eligibility Criteria
Adults over 18 with confirmed multiple myeloma, who've had less than two prior therapies and are planning or have recently completed an Autologous Stem Cell Transplant (ASCT). They must be MRD-positive post-ASCT, able to take oral meds, agree to contraception use, and not have certain health conditions that could interfere with the trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive isatuximab and lenalidomide maintenance therapy if MRD-positive after ASCT
Follow-up
Participants are monitored for disease response and MRD status every 12 months
Treatment Details
Interventions
- Isatuximab
- Lenalidomide
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Illinois at Chicago
Lead Sponsor
Huntsman Cancer Institute
Collaborator