Actively Recruiting
Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma
Led by University of Illinois at Chicago · Updated on 2026-02-23
50
Participants Needed
2
Research Sites
412 weeks
Total Duration
On this page
Sponsors
U
University of Illinois at Chicago
Lead Sponsor
H
Huntsman Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Confirmed diagnosis of multiple myeloma according to IMWG criteria; smoldering multiple myeloma or plasma cell leukemia not eligible
- R-ISS stage 1, 2, or 3 at diagnosis, or intent to treat with post-ASCT maintenance therapy if stage unknown
- Received up to two lines of therapy prior to ASCT without refractory disease to CD38 monoclonal antibody or lenalidomide
- Planned or completed ASCT with high dose melphalan within last 180 days without starting post-ASCT maintenance
- Achieved at least partial response before ASCT per IMWG criteria
- ECOG performance status of 0, 1, or 2 within 30 days prior to enrollment
- Adequate organ function as defined by blood counts, kidney, liver, and coagulation tests within 30 days prior to enrollment
- Confirmed access to lenalidomide for use during the study
- Ability to swallow oral medication whole without significant gastrointestinal impairment
- Willingness to use two forms of effective contraception or abstain from heterosexual activity during and after treatment as specified
- Willingness to take appropriate blood clot prevention during lenalidomide treatment
You will not qualify if you...
- Refractory to anti-CD38 monoclonal antibody therapy or lenalidomide as defined by IMWG
- Prior intolerance to isatuximab or lenalidomide
- Prior allogeneic stem cell transplant
- Prior solid organ transplant requiring immunosuppressive therapy
- Active or progressive additional malignancy requiring treatment, except certain treated cancers in remission
- Known central nervous system involvement by multiple myeloma
- Treatment with investigational drug within 30 days prior to enrollment
- Planned tandem autologous transplant approach for newly diagnosed multiple myeloma
- Uncontrolled intercurrent illness including active infection, unstable heart conditions, or psychiatric/social issues limiting compliance
- Pregnant or breastfeeding women
- Known HIV or AIDS with detectable viral load or low lymphocyte count
- Active uncontrolled hepatitis B or C infection
- Known positive test for hepatitis B surface antigen or active hepatitis B viral load unless controlled and treated appropriately
- Known hepatitis C virus infection unless viral load is undetectable or controlled with treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
2
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
K
Karen Sweiss, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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