eligibility_summary
Eligible: ≥18, biopsy-proven AL amyloidosis needing therapy, baseline serum monoclonal studies, completed 6 cycles Dara‑CyBorD (≥daratumumab+dex) with hematologic CR/VGPR/PR (low dFLC or organ response, stricter if baseline dFLC<5). ECOG 0–3, Hgb≥8, ANC≥1000, Plt≥50k, negative pregnancy test, consent, questionnaires, follow-up. Exclude: MM by CRAB/imaging/marrow, >1 cycle Dara maintenance, pregnancy/lactation/no contraception, active HBV, immunocompromised/HIV on ART, uncontrolled illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05898646 (EMILIA): Phase II, randomized study in AL amyloidosis comparing short (3–6 cycles) vs long (18 cycles) maintenance with daratumumab after 6-cycle Dara-CyBorD induction. Intervention: Daratumumab (Darzalex, IgG1κ human monoclonal antibody) given subcutaneously every 28 days. Mechanism: binds CD38 on clonal plasma cells and some immune cells, induces tumor cell death via ADCC, CDC, ADCP, and apoptosis, inhibits CD38 ectoenzyme (NADase) activity, reducing immunosuppressive adenosine and enhancing anti-tumor immunity. Targets: CD38+ plasma cells producing amyloidogenic light chains in bone marrow, CD38 signaling/ectoenzyme pathway, downstream reduction of serum free light chains and organ amyloid burden (heart, kidney). Outcomes: event-free survival (primary), hematologic response, MRD by flow, organ response, TTNT, infections, OS. Procedures: marrow/blood sampling, imaging, echocardiography, PROs.