eligibility_summary
Eligible adults (≥18) from parent Phase 1–3 isatuximab trials who are benefiting and eligible to start next cycle, or off drug at closure without local access, must use double contraception, not pregnant/breastfeeding, no sperm donation, and give consent. Exclude if progressive disease, unresolved >Grade 2 nonhematologic AEs, latest therapy not isatuximab-based, institutionalized/prisoners, unsuitable per investigator, site staff/family, or barred by local regulations.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 open-label extension in multiple myeloma to continue isatuximab-based regimens and assess long-term safety. Interventions and mechanisms: - Isatuximab IV/SC (anti-CD38 IgG1 monoclonal antibody): targets CD38 on malignant plasma cells, mediates ADCC/CDC/ADCP, induces apoptosis, and inhibits CD38 ectoenzyme activity reducing immunosuppressive adenosine. - Cemiplimab (anti-PD-1 mAb): checkpoint inhibitor restoring T-cell activity by blocking PD-1/PD-L1. - Lenalidomide and Pomalidomide (oral IMiDs): bind cereblon, promote IKZF1/3 degradation, downregulate IRF4/MYC, enhance T/NK cell function, anti-angiogenic. - Carfilzomib (proteasome inhibitor, epoxyketone): irreversibly inhibits 20S proteasome chymotrypsin-like activity, causing proteotoxic apoptosis. - Dexamethasone (corticosteroid): glucocorticoid receptor-mediated lympholysis. Targets/pathways: CD38+ plasma cells, PD-1/PD-L1 axis, cereblon-IKZF1/3 network, ubiquitin-proteasome system, complement, adenosine signaling, and innate/adaptive effector cells.