eligibility_summary
Inclusion: systemic AL amyloidosis, receiving 1st-line daratumumab+bortezomib+dexamethasone, life expectancy >12 wks, Hgb ≥70 g/L, O2 sat >90%, TBil ≤3×ULN, AST/ALT ≤3×ULN, informed consent. Exclusion: active multiple myeloma or lymphoplasmacytic lymphoma, advanced metastatic cancer, uncontrolled severe infection, severe autoimmune/immunodeficiency, active HBV/HCV, HIV or syphilis, any investigator-determined high risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests response-adapted therapy for AL amyloidosis with t(11,14). Initial regimen: daratumumab + bortezomib + dexamethasone (DBD), if rapid day-7 response, continue DBD, otherwise switch bortezomib to venetoclax (daratumumab + venetoclax + dexamethasone). Mechanisms/types: • Daratumumab: anti-CD38 monoclonal antibody, depletes clonal plasma cells via ADCC/CDC/apoptosis and immunomodulation. • Bortezomib: proteasome inhibitor, blocks 26S proteasome, causing toxic protein accumulation and apoptosis in plasma cells. • Dexamethasone: corticosteroid, lympholytic and anti-inflammatory, augments anti-plasma-cell killing. • Venetoclax: small-molecule BCL‑2 inhibitor (BH3 mimetic), restores apoptosis, particularly effective in t(11,14) clones with BCL‑2 dependence. Targets: amyloidogenic clonal plasma cells, CD38, ubiquitin–proteasome pathway, and BCL‑2 antiapoptotic pathway to rapidly suppress pathogenic light-chain production.