eligibility_summary
Include: Transplant-eligible NDMM, high/ultra-high-risk cytogenetics (del17p, t(4,14/14,16/14,20), 1q gain, ≥2=ultra-high), ≥PR after induction, age 18–75, KPS≥70, bili≤1.5×ULN, ALT≤2.5×ULN, CrCl≥40, contraception+REMS. Exclude: allergy, significant drug interactions, progressive disease, nonsecretory MM w/o measurable PET/BM, WM/POEMS/SMM/PCL, standard-risk or relapsed, active renal/liver/pulm disease, recent therapy, bleeding/infection, major CV risk, HIV, active HBV/HCV, other active cancer, pregnancy/lactation, serious cognitive/psychiatric.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm trial in newly diagnosed high‑risk multiple myeloma using elranatamab before and after autologous stem cell transplant (ASCT), with MRD‑guided maintenance (elranatamab + lenalidomide). Interventions/mechanisms: • Elranatamab: SC bispecific T‑cell engager antibody (CD3×BCMA) redirecting T cells to lyse BCMA+ malignant plasma cells, used for in‑vivo purging pre‑collection and for maintenance. • Lenalidomide: oral IMiD (cereblon E3 ligase modulator) enhancing T/NK activity and degrading IKZF1/3, impairing myeloma survival. • Plerixafor: CXCR4 antagonist to mobilize hematopoietic stem cells via CXCR4/CXCL12 axis disruption. • G‑CSF: cytokine stimulating myeloid progenitors and stem‑cell mobilization. • Melphalan, Busulfan: alkylating agents for conditioning (DNA crosslinking, marrow ablation). Targets/pathways: BCMA on plasma cells, CD3 on T cells, cereblon‑IKZF axis, CXCR4‑CXCL12 marrow retention, G‑CSF receptor signaling. Goal: achieve sustained MRD‑negative CR and plasma cell–free autografts.