Isatuximab and Lenalidomide Maintenance for Multiple Myeloma After Transplant

This study is testing a combination of two drugs, Isatuximab and Lenalidomide, for people with multiple myeloma who have undergone an autologous stem cell transplant (ASCT). This treatment is for those who still have minimal residual disease (MRD-positive), meaning a very small amount of cancer cells remain after their transplant. Isatuximab is a monoclonal antibody, a type of drug that targets specific cells. The study aims to see how many participants achieve an MRD-negative complete response (no detectable cancer cells) after one year. You may be able to join if you are 18 or older and have multiple myeloma. The study plans to enroll 50 participants.

Study design
This is a Phase II study for 50 participants. It is a single-arm study, meaning all participants receive the same treatment.
What's involved
Participants will receive Isatuximab intravenously and Lenalidomide by mouth. Treatment will continue for up to 3 years, or until the disease worsens or side effects are too severe. You will have regular monitoring, including bone marrow examinations and MRD testing.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for disease response and bone marrow MRD status every 12 months for a total of 3 years, or until disease progression or unacceptable toxicity.

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NCT05344833

Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Illinois at Chicago
~50 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:IsatuximabLenalidomide

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants that have MRD-negative CR rate, defined as 10-6
Measured over 1 year
Multiple Myeloma
2 sites across 2 states
Illinois1
Utah1

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  • Number of participants that have MRD-negative CR rate, defined as 10-61 year

    Evaluate the number of participants that have MRD-negative at 1 year that were MRD-positive multiple myeloma (MM) treated with isatuximab and lenalidomide based maintenance after ASCT