eligibility_summary
Adults ≥18 with NDMM after 4–6 cycles induction (IMiD+PI ± anti‑CD38) and a single ASCT 80–120 days before consent, no consolidation/maintenance (≤7 days LEN maintenance allowed), no progression, PR or VGPR, ECOG ≤1 (ECOG 2 if pain from bone lesions), ≤Grade 1 nonhematologic toxicities (except alopecia, Grade 2 neuropathy allowed). Exclude CNS MM, nonsecretory MM, uncontrolled infection, primary immunodeficiency, prior allo‑HSCT, gene/cellular or BCMA therapy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 randomized trial in NDMM post-ASCT with suboptimal response compares: (1) idecabtagene vicleucel (ide-cel, autologous BCMA-directed CAR T-cell therapy, biological) plus lenalidomide maintenance vs (2) lenalidomide alone. Ide-cel: patient T cells engineered with a 4-1BB/CD3ζ CAR targeting BCMA (TNFRSF17) on malignant plasma cells, triggering T-cell activation and cytotoxic killing. Lenalidomide: small-molecule IMiD that binds cereblon E3 ligase, promotes IKZF1/3 degradation, downregulates IRF4/MYC, enhances T- and NK-cell function, and has anti-angiogenic effects. Arm A uses lymphodepletion with fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) to reduce host lymphocytes and promote CAR-T expansion. Targets/pathways: BCMA+ plasma cells, cereblon–IKZF1/3–IRF4/MYC axis, immune effector T/NK activation, transient lymphodepletion (IL-7/IL-15 milieu).