eligibility_summary
Adults 18–72 with newly diagnosed symptomatic, measurable high‑risk multiple myeloma (per ISS/R‑ISS or high‑risk cytogenetics), KPS≥70 or ECOG≤2, post‑ASCT (melphalan±busulfan) with count recovery, PR or better pre‑maintenance, adequate organs (CrCl≥30, bili≤2 mg/dL [≤3 if Gilbert], AST/ALT≤3×ULN), consent and contraception. Exclude progression, recent investigational drugs, hypersensitivity, infection, uncontrolled illness, surgery <4 wks, HIV/hepatitis.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Isatuximab (SAR650984), an IV IgG1 monoclonal antibody targeting CD38, plus lenalidomide, an oral immunomodulatory drug (IMiD) that binds cereblon. Mechanisms: Isatuximab binds CD38 on malignant plasma cells to induce ADCC, CDC, ADCP, and direct apoptosis, it also inhibits CD38 ectoenzyme activity and depletes CD38+ immunosuppressive cells, enhancing anti-myeloma immunity. Lenalidomide drives cereblon-dependent degradation of IKZF1/IKZF3, reducing IRF4/MYC signaling, promoting myeloma cell death, boosting T- and NK-cell function, and exerting anti-angiogenic effects. Targets: CD38+ myeloma plasma cells, immune microenvironment (NK cells, T cells, Tregs), pathways—CD38 signaling/ectoenzymatic activity and the cereblon–IKZF1/3–IRF4/MYC axis.