eligibility_summary
Eligible: MM with measurable disease (serum M-protein ≥0.5 g/dL, urine ≥200 mg/24h, or involved FLC ≥10 mg/dL with abnormal ratio), relapsed/refractory with 1–3 prior lines, contraception per protocol, able to consent. Exclude: primary refractory MM, prior anti-CD38 <9 months or intolerant, prior carfilzomib, allergies to study components (e.g., captisol, polysorbate 80), active hepatitis A/B/C, AIDS-related illness, AL amyloidosis, severe comorbidities or noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05704049 (Phase 2, RRMM): Tests subcutaneous isatuximab plus carfilzomib and dexamethasone, comparing manual vs on-body delivery (OBDS) for isatuximab. Drugs/mechanisms: • Isatuximab—type: monoclonal antibody (IgG1), MOA: binds CD38 on myeloma cells, inducing ADCC, CDC, ADCP, and direct apoptosis, modulates CD38 ectoenzyme activity. • Carfilzomib—type: proteasome inhibitor (irreversible epoxyketone), MOA: inhibits 20S proteasome chymotrypsin-like activity → proteotoxic stress and apoptosis. • Dexamethasone—type: corticosteroid, MOA: glucocorticoid receptor–mediated lymphocyte apoptosis and anti-inflammatory effects, augments anti-myeloma activity and mitigates infusion reactions. Target cells/pathways: CD38+ malignant plasma cells, NK cell/macrophage effector pathways and complement cascade (isatuximab), ubiquitin–proteasome pathway (carfilzomib), glucocorticoid signaling (dexamethasone). Premeds (acetaminophen, diphenhydramine, montelukast, methylprednisolone) reduce infusion reactions.