eligibility_summary
Eligibility: ≥18 with multiple myeloma (BM plasma cells ≥10% or plasmacytoma) meeting CRAB/biomarker criteria and measurable disease. Transplant-ineligible (IMWG frailty 1–2), ECOG 0–2, adequate blood counts, liver/renal function, contraception per protocol, consent. Exclude: prior systemic MM therapy, ≥G2 neuropathy, recent major surgery, significant renal/hepatic/bleeding/infection/CV disease, other malignancy, HIV/HBV/HCV per limits, corneal disease, prohibited drugs/vaccines.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1/2 open-label trial in transplant-ineligible newly diagnosed multiple myeloma testing: 1) Belantamab mafodotin-blmf: anti-BCMA antibody–drug conjugate (ADC) delivering MMAF. Mechanism: binds BCMA on malignant plasma cells, internalizes, releases MMAF to inhibit microtubules and induce apoptosis, also mediates ADCC/ADCP. 2) Lenalidomide: immunomodulatory drug (IMiD) and cereblon E3 ligase modulator causing IKZF1/3 degradation, boosting IL-2, T/NK activation, anti-angiogenesis, and direct anti-myeloma effects. 3) Dexamethasone: glucocorticoid inducing apoptosis of lymphoid/plasma cells and anti-inflammatory effects. 4) Nirogacestat: oral gamma-secretase inhibitor that reduces BCMA shedding, increasing cell-surface BCMA to potentiate anti-BCMA therapy, also affects Notch signaling. Targets/pathways: BCMA+ plasma cells, gamma-secretase/BCMA shedding, cereblon–IKZF axis, immune effector (T/NK) function, glucocorticoid receptor signaling.