eligibility_summary
Adults >18 with smoldering multiple myeloma ≤5 yrs, measurable disease, BMPCs 10–<60%, and ≥2 high‑risk factors (M‑protein ≥2 g/dL, BMPC >20%, FLC ratio >20), ECOG 0–1, adequate labs, consent, WOCBP negative test and dual contraception. Exclude prior MM therapy, any CRAB/SLiM‑CRAB, other plasma cell disorders, recent plasmapheresis/surgery, major cardiac disease or neuropathy, active infection (HIV/HBV/HCV/COVID), recent malignancy, pregnancy, psych illness, uncontrolled DM, recent live vaccine, steroids >10 mg, legal incapacity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase 2, single-arm study in high‑risk smoldering multiple myeloma. Intervention: Elranatamab, a subcutaneous bispecific T‑cell–engaging monoclonal antibody (immunotherapy). Mechanism: Simultaneously binds BCMA (TNFRSF17) on malignant plasma cells and CD3 on T cells, forming an immune synapse that activates T‑cell receptor/CD3 signaling, drives cytotoxic T‑cell killing, and induces apoptosis of BCMA+ plasma cells (with associated cytokine release). Target cells/pathways: BCMA-expressing plasma cells, T‑cell activation via CD3/TCR signaling, impacts BCMA/BAFF‑APRIL axis on plasma cells. Dosing: SC elranatamab in 28‑day cycles for up to 24 cycles. Primary aim: efficacy, key secondary: safety.