eligibility_summary
Adults (≥18) with newly diagnosed MM who had triplet/quad therapy including ≥2 of IMiD/PI/anti‑CD38, ≥4 cycles, achieved ≥VGPR but are MRD+ (≤10^-5). ECOG ≤1 (≤2 if due to MM pain), adequate organs, contraception, consent, compliant. Exclude: prior MM therapy beyond initial or any SCT, recent high-dose steroids, investigational drugs, live vaccines, HBV/HCV or disqualifying HIV, significant cardiac/active illness, recent other cancers, med contraindications, pregnancy/breastfeeding, inability to consent.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm consolidation trial in newly diagnosed multiple myeloma patients who remain MRD-positive after induction. Intervention: Linvoseltamab, an intravenous bispecific T‑cell–engager monoclonal antibody (biologic) that binds BCMA (TNFRSF17) on malignant plasma cells and CD3 on T cells. Mechanism: brings T cells into proximity with BCMA+ myeloma cells, triggering CD3/TCR activation, cytokine release, and perforin/granzyme‑mediated cytotoxic killing, step‑up dosing used to limit CRS. Cells/pathways targeted: BCMA-expressing clonal plasma cells in marrow/extramedullary disease, T‑cell CD3/TCR signaling and immune synapse formation. Goal: convert MRD+ to MRD− and prolong disease control, potentially delaying transplant.