eligibility_summary
Include: 18–80, primary AL amyloidosis, ECOG 0–2, measurable dFLC >20 mg/L with abnormal κ/λ, adequate marrow/organ function, contraception (neg test, not lactating). Exclude: non‑AL, mAb/daratumumab allergy, pregnancy, ASCT/GVHD <12 mo, asthma/COPD (FEV1<50%), major heart disease/QTc>470, active HAV/HBV/HCV/HIV, PCL/WM/POEMS, neuropathy ≥2, major surgery <14 d or planned, other cancer ≤3 y, other trials or serious comorbidity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm trial in newly diagnosed AL amyloidosis testing DPd: daratumumab (IV) or daratumumab and hyaluronidase-fihj (SC) plus pomalidomide and dexamethasone. Daratumumab is an anti-CD38 monoclonal antibody that kills clonal plasma cells via CDC, ADCC, ADCP, and apoptosis. Hyaluronidase-fihj is a recombinant enzyme that transiently depolymerizes hyaluronan to enable efficient SC delivery (not antitumor). Pomalidomide is an immunomodulatory agent (IMiD) that binds cereblon, promoting IKZF1/3 degradation, directly inhibiting plasma cells and enhancing T/NK-cell activity, also anti-angiogenic. Dexamethasone is a glucocorticoid corticosteroid inducing lymphoid/plasma-cell apoptosis and anti-inflammatory effects. Targets/pathways: CD38+ clonal plasma cells producing amyloid light chains, CRBN–IKZF1/3 pathway, immune effector mechanisms, glucocorticoid receptor signaling.