eligibility_summary
Adults >18 with MM (IMWG, R-ISS I–III), ≥PR pre-ASCT, ≤2 prior lines, planned or ≤180 days post-melphalan ASCT. ECOG 0–2, adequate organ function (CrCl ≥30, no dialysis), access to lenalidomide, agree to contraception and DVT prophylaxis. Exclude: refractory to CD38 mAb or lenalidomide, prior allo/solid transplant, CNS MM, tandem ASCT plan, uncontrolled illness, or pregnancy/breastfeeding. HIV/HCV allowed if VL undetectable, active HBV excluded.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm trial of maintenance isatuximab + lenalidomide for MRD-positive patients after autologous transplant in multiple myeloma. Isatuximab: anti-CD38 IgG1 monoclonal antibody, binds CD38 on malignant plasma cells, inhibits CD38 ectoenzyme activity, and induces Fc-mediated killing (ADCC/ADCP/CDC) and direct apoptosis, may also reduce CD38+ immunosuppressive cells. Lenalidomide: oral immunomodulatory drug (IMiD), binds cereblon E3 ligase causing IKZF1/IKZF3 degradation, leading to anti-myeloma effects, anti-angiogenesis, and enhanced T- and NK-cell activity. Targets/pathways: CD38 on myeloma plasma cells, cereblon–IKZF axis, augmentation of NK/T-cell responses and tumor microenvironment modulation.