OncoMatch/Clinical Trials/NCT04558931
Clinical Trial for Autologus NK Cells Alone or in Combination With Isatuximab as Maintenance for Multiple Myeloma
Is NCT04558931 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including CellProtect and Isatuximab for multiple myeloma.
Treatment: CellProtect · Isatuximab — Prospective, single center, randomized, open label, parallel group, 2-arm study assessing the clinical benefit in term of enhancement of overall response rate of Isatuximab in combination with CellProtect as compared to Isatuximab for the treatment of patients with newly diagnosed multiple myeloma who are eligible for stem cell transplantation (SCT) as maintenance after SCT.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: NK cell therapy
Prior or concurrent exposure to NK cells and NK like T cells
Cannot have received: approved or investigational treatments for multiple myeloma
Approved or investigational treatments for MM
Cannot have received: investigational drug
Received any investigational drug within 14 days or 5 half-lives of the investigational drug, whichever is longer
Cannot have received: systemic therapy for symptomatic multiple myeloma
Exception: emergency use of a short course (equivalent of dexamethasone 40 mg/day for 4 days) of corticosteroids, if completed within 14 days prior to randomization
Prior or current systemic therapy, or SCT for symptomatic multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for 4 days) of corticosteroids, if completed within 14 days prior to randomization
Cannot have received: stem cell transplant
Exception: emergency use of a short course (equivalent of dexamethasone 40 mg/day for 4 days) of corticosteroids, if completed within 14 days prior to randomization
Prior or current systemic therapy, or SCT for symptomatic multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for 4 days) of corticosteroids, if completed within 14 days prior to randomization
Lab requirements
Blood counts
Hemoglobin ≥8 g/dL; Platelets ≥70 × 10^9/L if <50% BM plasma cells, and ≥30 × 10^9/L if ≥50% BM plasma cells; Platelet transfusion not allowed within 3 days before screening
Liver function
Total bilirubin ≤1.5 × ULN (except for known Gilbert syndrome); AST and/or ALT ≤3 × ULN
Cardiac function
No second/third degree heart block, poorly controlled hypertension, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, NYHA class III or IV CHF, grade ≥3 arrhythmias, stroke or TIA within 6 months prior to randomization; LVEF ≥40%
Hemoglobin <8 g/dL. Platelets <70 × 10^9/L if <50% of BM nucleated cells are plasma cells, and ≤30 × 10^9/L if ≥50% of BM nucleated cells are plasma cells. Platelet transfusion is not allowed within 3 days before the screening haematological test. Total bilirubin >1.5 × ULN, except for known Gilbert syndrome. AST and/or ALT >3 × ULN. Second/third degree heart block, poorly controlled hypertension, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV CHF, grade ≥3 arrhythmias, stroke or TIA within 6 months prior to randomization. LVEF <40%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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