eligibility_summary
Include: adults 18–70 with untreated, measurable MM, eligible for high‑dose melphalan (200 mg/m²) and autologous SCT. Exclude: hypersensitivity, systemic AL amyloidosis, plasma cell leukemia, prior chemo/RT in 5y (except local), NYHA III–IV, active HBV/HCV or related liver disease, HIV, uncontrolled infection, severe renal failure/dialysis, neuropathy ≥G2, recent cancers, platelets <75×10^9/L, Hb ≤8 g/dL (unless MM), ANC <1.0×10^9/L, Ca >14 mg/dL, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05804032 tests route of isatuximab delivery (subcutaneous vs intravenous) added to RVd induction in transplant-eligible, newly diagnosed multiple myeloma. Drugs/mechanisms: Isatuximab (Sarclisa) is an anti-CD38 IgG1 monoclonal antibody inducing ADCC, CDC, ADCP, direct apoptosis, and inhibiting CD38 ectoenzyme activity (NAD metabolism). Lenalidomide is an IMiD that binds cereblon, degrades Ikaros/Aiolos, enhances T/NK cytotoxicity, and is anti-angiogenic. Bortezomib is a reversible 26S proteasome inhibitor (β5), causing ER stress/apoptosis and NF-κB inhibition. Dexamethasone is a glucocorticoid receptor agonist inducing lymphoid apoptosis and immunosuppression. Targets/pathways: CD38+ malignant plasma cells and immunosuppressive subsets, Fc-effector cytotoxic mechanisms, CD38 ectoenzyme, proteasome/UPR and NF-κB, cereblon–Ikaros/Aiolos axis with T/NK activation, glucocorticoid receptor–mediated apoptosis. Primary endpoint: VGPR+ after induction. Secondary: MRD negativity, PROs.