eligibility_summary
Adults (≥18) with relapsed MM, 1–3 prior regimens, prior response (PR+), ECOG 0–2, toxicities resolved/stable, eligible for isatuximab + pomalidomide/dex or isatuximab + carfilzomib/dex, consented. Exclude drug contraindications, anti‑CD38 refractory/intolerant, prior ICARIA/IKEMA use, allo-HCT or planned HCT, recent other cancers, CNS MM, PCL, WM, POEMS, amyloidosis, serious comorbidity (e.g., uncontrolled COPD, cardiac disease), HBV PCR+, HIV/HCV, lactation, other trials, unable to consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3, open-label, non-inferiority trial in relapsed/refractory multiple myeloma comparing standard IKEMA (isatuximab+carfilzomib+dexamethasone) or ICARIA (isatuximab+pomalidomide+dexamethasone) with continuous dexamethasone vs stopping dexamethasone after 2 cycles. Drugs/mechanisms: Isatuximab—anti-CD38 IgG1 monoclonal antibody, targets CD38 on malignant plasma cells, mediates ADCC/CDC, apoptosis, and modulates CD38 ectoenzyme activity. Pomalidomide—IMiD, binds cereblon to degrade Ikaros/Aiolos, enhancing T/NK activity and direct anti-myeloma effects. Carfilzomib—irreversible proteasome inhibitor (20S, β5), blocks protein degradation, induces apoptosis and suppresses NF-κB signaling. Dexamethasone—glucocorticoid, GR-mediated lymphocyte/myeloma cell apoptosis and anti-inflammatory effects. Targets/pathways: CD38+ plasma cells, cereblon E3 ligase/Ikaros-Aiolos axis, ubiquitin–proteasome pathway, immune effector ADCC, NF-κB and apoptosis pathways.