eligibility_summary
Adults ≥18 with high‑risk SMM (Mayo 20‑2‑20: ≥2 of M‑protein ≥2 g/dL, FLC ≥20, BMPC 20–<40%, or ≥95% aberrant BMPC with immunoparesis). ECOG ≤1, eGFR ≥40, bili ≤2.0, AST/ALT ≤3×ULN, Hgb ≥8, ANC ≥1.0, Plt ≥75, ALC ≥0.3. HIV negative/controlled. Contraception/pregnancy testing, consent. Exclude: MGUS/standard‑risk SMM/active MM/amyloidosis/extramedullary, cilta‑cel allergy, recent major surgery, pregnancy, serious comorbidity/neuro disease, recent malignancy, active viral infection.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single‑arm trial in high‑risk smoldering multiple myeloma tests Dara‑VRD induction followed by ciltacabtagene autoleucel (cilta‑cel). Interventions and mechanisms: Cilta‑cel is an autologous anti‑BCMA CAR‑T cell therapy (lentiviral‑transduced T cells) that binds BCMA on malignant plasma cells/mature B cells, activating T‑cell cytotoxicity. Daratumumab is an anti‑CD38 IgG1 mAb inducing ADCC/CDC/ADCP and direct apoptosis of CD38+ plasma cells and immunosuppressive subsets. Bortezomib is a reversible 26S proteasome inhibitor disrupting NF‑κB signaling and triggering ER‑stress apoptosis. Lenalidomide is an IMiD that binds cereblon, degrades Ikaros/Aiolos, boosts T/NK function, and has anti‑angiogenic/direct antimyeloma effects. Dexamethasone is a glucocorticoid inducing lymphoid apoptosis. Targets/pathways: BCMA, CD38, proteasome/NF‑κB, cereblon‑IKZF1/3 axis, glucocorticoid receptor, engages effector T/NK cells.