eligibility_summary
Include: Adults ≥18 with R/R MM, ECOG ≤2, measurable disease, ≥1 prior line incl ≥2 cycles of lenalidomide and a proteasome inhibitor, progression ≤60 d of last therapy, ANC ≥1000, Plt ≥75k, Hb ≥8, CrCl ≥30, Pomalyst REMS, contraception. Exclude: ocular disease/contacts, recent therapy/trials, prior anti‑BCMA or recent anti‑CD38, pregnancy/lactation, active HIV/HBV/HCV, neuropathy ≥2, recent SCT, active infection, recent surgery/live vaccine, unresolved >G1 toxicity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm trial in relapsed/refractory multiple myeloma testing four agents: 1) Isatuximab: IgG1 monoclonal antibody targeting CD38 on myeloma/plasma cells, triggers ADCC, CDC, ADCP, direct apoptosis, and inhibits CD38 ectoenzyme activity. 2) Belantamab mafodotin (GSK2857916): anti-BCMA antibody–drug conjugate delivering MMAF (microtubule inhibitor), binds BCMA on malignant plasma cells, internalizes to disrupt microtubules and kill cells, also mediates ADCC/ADCP. 3) Pomalidomide: oral immunomodulatory drug (IMiD) binding cereblon to degrade Ikaros/Aiolos, enhancing T- and NK-cell cytotoxicity, anti-myeloma and anti-angiogenic. 4) Dexamethasone: oral glucocorticoid inducing apoptosis of lymphoid/myeloma cells and reducing inflammation. Targets: CD38+ and BCMA+ plasma cells, cereblon E3 ligase pathway, microtubules, immune effector activation.