RecruitingPhase 2NCT05344833

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


Sponsor

University of Illinois at Chicago

Enrollment

50 participants

Start Date

Jan 5, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether isatuximab (an antibody targeting myeloma cells) combined with lenalidomide (a standard maintenance drug) can eliminate residual multiple myeloma in patients who still have detectable cancer after an autologous stem cell transplant (a transplant using the patient's own stem cells). **You may be eligible if...** - You are over 18 years old - You have been diagnosed with multiple myeloma (not smoldering or plasma cell leukemia) - You completed an autologous stem cell transplant and still test positive for minimal residual disease (MRD positive) - You are willing to take blood clot prevention medication (aspirin, heparin, or similar) **You may NOT be eligible if...** - You have smoldering myeloma or plasma cell leukemia - You have significant amyloid-related organ damage - You are MRD-negative after transplant - You have health conditions that prevent use of lenalidomide or isatuximab Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIsatuximab

Isatuximab 10mg/kg IV Days 1,8, 15, 22 Cycle 1 (all cycles 28 days). Isatuximab 10mg/kg Days 1, 15 Cylces 2 and 3. Isatuximab 10mg/kg Day 1, Cylces 4-39.

DRUGLenalidomide

Lenalidomide 15mg PO Days 1-21 Cycle 4 and can continue until disease progression.


Locations(2)

University of Illinois at Chicago

Chicago, Illinois, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

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NCT05344833


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