eligibility_summary
Eligibility: Adults ≥18, ECOG 0–2, MM per IMWG with ≥3 prior lines incl PI, IMiD, and anti‑CD38, prior non‑belantamab anti‑BCMA (incl CAR‑T/bispecific) allowed. Requires measurable disease and adequate marrow, hepatic, and renal function, negative pregnancy test. Excludes plasma cell leukemia/amyloidosis/POEMS/WM, prior belantamab, active infection, significant cardiac/liver disease, uncontrolled HBV/HCV/HIV, corneal disease, allo‑SCT, pregnancy. No contact lenses during therapy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05847569 tests belantamab mafodotin (Blenrep, belantamab mafodotin-blmf), an antibody–drug conjugate (biologic) composed of a humanized anti-BCMA IgG1 linked to mafodotin (MMAF, a microtubule inhibitor). Mechanism: the antibody binds BCMA (TNFRSF17) on malignant plasma cells, is internalized, and delivers MMAF to disrupt microtubules and induce apoptosis, the afucosylated IgG1 can also mediate ADCC/ADCP. Two dosing strategies are compared (low-dose every 6 weeks vs day 1 then a 3-week cycle followed by every 6 weeks) to maintain efficacy while reducing ocular keratopathy. Targets/pathways: BCMA-expressing plasma cells in multiple myeloma, BCMA signaling axis and soluble BCMA levels (correlative), microtubule cytoskeleton disruption as the cytotoxic mechanism. Non-therapeutic procedures: blood/bone marrow sampling and imaging for response and MRD.