eligibility_summary
Adults ≥18, ECOG 0–2 with NDMM cast nephropathy (biopsy or UAE<25%+FLC>50) or biopsy-proven MGRS with monoclonal gammopathy and clonal plasma cells, measurable myeloma markers, eGFR <40 (or proteinuria >1 g/d for MGRS), adequate counts/liver, contraception, no nephrotoxins/obstruction. Exclude non–plasma cell MGRS, PCL/AL/POEMS, prior anti–plasma-cell therapy, recent surgery/radiation/chemo/investigational drugs, major cardiac/pulmonary illness, neuropathy ≥2, active HIV/HBV/HCV, strong CYP3A4/1A2 use, recent live vaccine/plasmapheresis.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06083922 tests CyBorD plus daratumumab SC for MGRS (incl. myeloma cast nephropathy). Drugs/mechanisms (type): - Cyclophosphamide: alkylating chemotherapy, DNA crosslinker causing cytotoxicity of proliferating/clonal plasma cells. - Bortezomib: reversible 26S proteasome inhibitor, blocks protein degradation, induces ER stress/apoptosis and suppresses NF-κB. - Dexamethasone: glucocorticoid steroid, pro‑apoptotic to lymphoid/plasma cells, anti‑inflammatory. - Daratumumab: anti‑CD38 IgG1 monoclonal antibody (immunotherapy) mediating ADCC/CDC/ADCP and direct apoptosis. Targets/pathways: CD38+ clonal plasma cells, ubiquitin‑proteasome/NF‑κB axis, DNA damage response, glucocorticoid receptor signaling, aim is to lower monoclonal light chains and improve kidney injury in MGRS.