eligibility_summary
Eligible: biopsy-proven, treatment-naïve AL amyloidosis with FISH t(11,14) ≥10% and dFLC >50 mg/L. Exclude: uncontrolled infection, other active malignancy, co-diagnosis of MM or WM, significant conduction/arrhythmia (Mobitz II/3rd-degree AV block unless paced, sustained or recurrent VT), HIV+, HBV DNA >1000, HCV+ unless SVR, recent moderate/strong CYP3A inducers/inhibitors, ANC<1, Hgb<8, Plt<100×10^9/L, ALT/AST>2.5×ULN, bili>3×ULN, eGFR<15 or dialysis.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm trial testing Dara-VenD in newly diagnosed AL amyloidosis with t(11,14). Interventions: Daratumumab—anti-CD38 monoclonal antibody, Venetoclax—oral small-molecule BCL-2 inhibitor (BH3 mimetic), Dexamethasone—corticosteroid. Mechanisms: Daratumumab binds CD38 on clonal plasma cells, driving ADCC, CDC, apoptosis, and immunomodulation, Venetoclax inhibits BCL-2 to trigger mitochondrial apoptosis, particularly effective in t(11,14) (CCND1/IGH) clones with high BCL-2 dependence, Dexamethasone is lympholytic and augments anti–plasma cell effects. Targets: Amyloidogenic light chain–producing plasma cells, CD38 surface antigen, BCL-2–mediated mitochondrial apoptosis pathway (caspase activation), immune effector pathways (NK/macrophage).