RecruitingMultiple Myeloma
Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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)
Sponsor: University of Illinois at Chicago
You may qualify if…
- ✓ 1. Age \> 18 years
- ✓ 2. Patients must have a confirmed diagnosis of multiple myeloma according to IMWG criteria. Patients with smoldering multiple myeloma, or plasma cell leukemia are not eligible. Patients must not have significant amyloid organ dysfunction per the study chair.
- ✓ 3. R-ISS stage 1, 2 or 3 at diagnosis. If stage at diagnosis is not known, patient may be enrolled if the intent is to treat with post -ASCT maintenance therapy.
- ✓ 4. Received up to or less than 2 lines of therapy prior to ASCT (as long as they did not meet IMWG refractory disease for CD38 monoclonal antibody or lenalidomide therapies as defined in exclusion).
- ✓ 5. Patients are planned to undergo ASCT with high dose melphalan, or have completed ASCT with high dose melphalan within the last 180 days and have not yet initiated post-ASCT maintenance.
- ✓ 6. Obtain at least partial response according to IMWG criteria prior to autologous stem cell transplant
- ✓ 7. ECOG performance status of 0, 1, or 2 within 30 days prior to enrollment.
- ✓ 8. Demonstrate adequate organ function as defined in the table below; all screening labs are to be obtained within 30 days prior enrollment.
You may not qualify if…
- ✕ 1. Refractory to anti-CD38 monoclonal antibody therapy OR lenalidomide as defined by the IMWG (defined as non-responsive or progressive disease on therapy or within 60 days of last treatment).
- ✕ 2. Prior intolerance to isatuximab or lenalidomide.
- ✕ 3. Prior allogeneic stem cell transplant.
- ✕ 4. Prior solid organ transplant requiring immunosuppressive therapy.
- ✕ 5. Known additional malignancy that is active and/or progressive requiring treatment; exceptions include adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
- ✕ 6. Known CNS involvement by multiple myeloma, defined by positive CSF cytology for plasma cells, leptomeningeal involvement, or parenchymal CNS plasmacytoma at time of enrollment. Lumbar puncture is not required.
- ✕ 7. Treatment with any investigational drug within 30 days prior to enrollment.
- ✕ 8. Planned transplant is considered part of tandem autologous transplant approach for newly diagnosed MM.
Where it's recruiting
Source: ClinicalTrials.gov · NCT05344833 · last updated 2026-02-23