eligibility_summary
Eligibility: Systemic AL amyloidosis, informed consent, dFLC ≥50 mg/L, and treatment including daratumumab, bortezomib, and dexamethasone. Excludes active multiple myeloma or lymphoplasmacytic lymphoma, advanced metastatic tumors, severe or uncontrolled infection, severe autoimmune or immunodeficiency disease, active HBV/HCV (DNA/RNA+), HIV, or syphilis, or any condition increasing risk or affecting study results.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06627309 is a prospective observational study in systemic AL amyloidosis assessing whether rapid dFLC decline (C1D7/C1D14) predicts complete hematologic response during daratumumab-based therapy. Interventions (standard of care): daratumumab (IV/SC) — anti-CD38 IgG1 monoclonal antibody that targets CD38 on clonal plasma cells, inducing ADCC/CDC/apoptosis and immunomodulation, bortezomib — proteasome inhibitor blocking the 26S proteasome, disrupting protein homeostasis and NF-κB signaling to trigger plasma-cell apoptosis, dexamethasone — glucocorticoid that activates the glucocorticoid receptor, immunosuppressive and pro-apoptotic in lymphoid/plasma cells, cyclophosphamide (optional) — alkylating agent causing DNA crosslinks and cytotoxicity. Targeted cells/pathways: CD38+ clonal plasma cells producing amyloidogenic light chains, proteasome/ubiquitin-NF-κB axis, glucocorticoid receptor signaling, and DNA damage pathways.