OncoMatch/Clinical Trials/NCT05344833
Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple Myeloma
Is NCT05344833 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Isatuximab and Lenalidomide for multiple myeloma.
Treatment: Isatuximab · Lenalidomide — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Disease stage
Required: Stage R-ISS STAGE 1, R-ISS STAGE 2, R-ISS STAGE 3 (R-ISS)
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.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: autologous stem cell transplant (high dose melphalan) — planned or completed within last 180 days and not yet initiated post-ASCT maintenance
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.
Cannot have received: allogeneic stem cell transplant
Prior allogeneic stem cell transplant.
Cannot have received: solid organ transplant requiring immunosuppressive therapy
Prior solid organ transplant requiring immunosuppressive therapy.
Cannot have received: anti-CD38 monoclonal antibody
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).
Cannot have received: lenalidomide (lenalidomide)
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).
Cannot have received: isatuximab (isatuximab)
Prior intolerance to isatuximab or lenalidomide.
Cannot have received: lenalidomide (lenalidomide)
Prior intolerance to isatuximab or lenalidomide.
Lab requirements
Blood counts
WBC ≥ 1500/mm3; ANC ≥ 1000/mm3; Platelets ≥ 50,000/mm3
Kidney function
Calculated creatinine clearance ≥ 30 mL/min using either the Cockcroft-Gault formula or estimated GFR, and not requiring continuous or intermittent dialysis
Liver function
Bilirubin ≤ 2.5 × ULN; AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN
Demonstrate adequate organ function as defined in the table below; all screening labs are to be obtained within 30 days prior enrollment. Hematologic White blood cell (WBC) ≥ 1500/mm3 Absolute Neutrophil Count (ANC) ≥ 1000/mm3 Platelets ≥ 50,000/mm3 Renal Calculated creatinine clearance ≥ 30 mL/min using either the Cockcroft-Gault formula or estimated GFR, and not requiring continuous or intermittent dialysis Hepatic Bilirubin ≤ 2.5 × upper limit of normal (ULN) Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Illinois at Chicago · Chicago, Illinois
- Huntsman Cancer Institute · Salt Lake City, Utah
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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