eligibility_summary
Adults ≥18 with active MM and t(11,14) by IDE FISH (sample ≤72h), measurable disease, ECOG 0–2, adequate blood/renal/hepatic labs, life expectancy ≥12 wks. Group 1: ≥1 prior line, no venetoclax. Group 2: newly diagnosed, ≤1 cycle, not transplant candidates. Must consent, use contraception/REMS, provide marrow, follow-up. Exclude: recent malignancy, other trials/Tx, major surgery ≤14d, HIV, strong/mod CYP3A meds, allergies, GI absorption issues, HF >NYHA II, active HCV.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I trial in t(11,14) multiple myeloma tests venetoclax with: (a) daratumumab+dexamethasone (Ven-Dd), (b) lenalidomide+dexamethasone (Ven-Rd), or (c) daratumumab+lenalidomide+dexamethasone (Ven-DRd). Venetoclax: oral small-molecule BH3-mimetic BCL-2 inhibitor, induces intrinsic apoptosis in BCL-2–dependent myeloma (notably t(11,14)). Lenalidomide: oral immunomodulatory drug (IMiD)/cereblon E3-ligase modulator, degrades IKZF1/3 (Ikaros/Aiolos), boosts T/NK function, anti-angiogenic, direct cytotoxicity. Daratumumab: anti-CD38 IgG1 monoclonal antibody, targets CD38 on myeloma/immune cells, mediates ADCC/CDC/ADCP and immunomodulation. Dexamethasone: corticosteroid, lympholytic, anti-inflammatory, augments cytotoxicity. Target cells/pathways: malignant plasma cells with high BCL-2, CD38+ myeloma, apoptosis (BCL-2/MOMP), CD38-directed immune killing, cereblon–IKZF1/3 axis, glucocorticoid receptor signaling, engages T and NK effector cells.