eligibility_summary
Eligible: ≥18, ECOG 0–2, symptomatic MM with archival marrow, MRD+ by clonoSEQ 90–120 days after upfront ASCT, adequate ANC/platelets/LFTs, consent, Revlimid REMS, effective contraception. Exclude: MM progression, other anti‑MM therapy post day +30, serious illness, prior organ transplant on immunosuppression, HIV, active HBV/HCV (unless controlled/treated), drug/component allergy, other malignancy needing treatment, major cardiac disease, recent surgery/infection, recent trial, pregnancy/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05690984 is a phase II, single-arm consolidation trial post-ASCT for MRD-positive multiple myeloma testing IsaRD: isatuximab + lenalidomide + dexamethasone. Isatuximab: anti-CD38 IgG1 monoclonal antibody, induces myeloma plasma-cell death via ADCC, CDC, ADCP, and direct apoptosis, inhibits CD38 ectoenzyme/adenosine signaling and can deplete CD38+ immunosuppressive cells. Lenalidomide: oral immunomodulatory drug (IMiD) that binds cereblon E3 ligase, degrading IKZF1/3, promoting myeloma apoptosis, boosting IL-2, and enhancing T/NK-cell cytotoxicity and anti-CD38 ADCC. Dexamethasone: corticosteroid/glucocorticoid with lympholytic, pro-apoptotic, and anti-inflammatory effects (also premedication). Targets/pathways: CD38 on malignant plasma cells, cereblon–IKZF1/3 pathway, NK/T cells, macrophages, complement, goal: eradicate bone marrow MRD to ≤10^-5 by 12 months (clonoSEQ).