eligibility_summary
Eligibility: MIDD diagnosis without prior anti–plasma cell therapy, ECOG 0–2, ANC ≥1.0×10^9/L, Hgb ≥70 g/L, Plt ≥50×10^9/L, TBil ≤3×ULN, AST/ALT ≤3×ULN, informed consent. Exclude: prior MIDD therapy except ≤160 mg dexamethasone, active multiple myeloma or lymphoplasmacytic lymphoma, advanced/metastatic cancers, uncontrolled infection, severe autoimmune/immunodeficiency, active HBV/HCV, HIV/syphilis, investigator-judged high risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, open-label, single-arm trial in newly diagnosed monoclonal immunoglobulin deposition disease testing Dara-CyBorD (daratumumab, bortezomib, cyclophosphamide, dexamethasone). Drugs and mechanisms: Daratumumab—anti-CD38 IgG1 monoclonal antibody that depletes CD38+ clonal plasma cells via ADCC, CDC, ADCP, and apoptosis. Bortezomib—reversible 26S proteasome inhibitor inducing ER stress–mediated apoptosis and inhibiting NF-κB, reducing light-chain synthesis. Cyclophosphamide—alkylating agent causing DNA crosslinks, cytotoxic to plasma/lymphoid cells. Dexamethasone—glucocorticoid with lympholytic, pro-apoptotic, anti-inflammatory effects. Targets: pathogenic plasma-cell clone producing monoclonal immunoglobulin/light chains, pathways include CD38, proteasome/UPR, DNA damage, glucocorticoid receptor and NF-κB. Primary endpoint: complete hematologic response at 6 months.