eligibility_summary
Adults ≥18 with IMWG-defined, measurable multiple myeloma, ≥PR to ≥1 prior line, relapsed/refractory after PI and IMiD with progression, ECOG 0–2, not pregnant, using contraception, consent to marrow biopsy. Exclude prior anti‑CD38 (daratumumab), recent MM therapy, auto HSCT <12 wks, any allo/planned HSCT, plasma cell leukemia/POEMS/amyloidosis, Waldenström/IgM, other recent cancers, plasmapheresis <28 d, CNS/meningeal disease, pregnancy/breastfeeding/conception plans.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3, double-blind, randomized trial comparing BCD-264 (a proposed biosimilar of daratumumab) vs Darzalex in relapsed/refractory multiple myeloma. Drugs/interventions: BCD-264 and Darzalex, both are anti-CD38 human IgG1κ monoclonal antibodies (IV). Mechanism of action: bind CD38 on malignant plasma cells, inducing immune-mediated cytotoxicity (ADCC, CDC, antibody-dependent phagocytosis) and direct apoptosis, inhibit CD38 ectoenzyme activity, reduce CD38+ immunosuppressive cells, potentially enhancing T-cell–mediated antitumor activity. Targets: CD38-expressing clonal plasma cells, immune effector pathways involving NK cells, macrophages, complement, and the bone marrow immune microenvironment.