eligibility_summary
Eligible: adults (≥18) with M‑protein–related cardiac disease (cardiac amyloidosis or M‑component plus arrhythmia/cardiac enzyme or function abnormalities after excluding other cardiac causes), ECOG 0–2, consent. Exclude: acute MI, severe lung/liver/kidney dysfunction, recent major surgery/radiation/serious infection, mental illness, pregnancy/lactation or inadequate contraception, other cancer ≤2y, allergy to DARA/BOR/DEX, HIV, active HBV/HCV, other trial, investigator deems unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06297681 tests a fixed regimen of daratumumab + bortezomib + dexamethasone (DBd) with add-on dapagliflozin in adults with M-protein–related cardiac disease (often AL amyloidosis). Drug types and mechanisms: Daratumumab—anti-CD38 monoclonal antibody, depletes CD38+ clonal plasma cells via ADCC/CDC/apoptosis and immune modulation. Bortezomib—26S proteasome inhibitor, induces unfolded-protein stress and apoptosis in plasma cells, suppresses NF-κB signaling. Dexamethasone—glucocorticoid, activates glucocorticoid receptor, lymphocytotoxic and anti-inflammatory, augments cytotoxic therapy. Dapagliflozin—SGLT2 inhibitor, blocks renal glucose/sodium reabsorption, causing glucosuria/natriuresis with cardiorenal benefits (reduced preload/afterload). Targets/pathways: clonal plasma cells producing amyloidogenic M-protein, CD38, ubiquitin-proteasome/UPR, glucocorticoid pathways, renal SGLT2 with downstream cardiomyocyte stress reduction.