eligibility_summary
Adults (≥18) with relapsed multiple myeloma per IMWG, able to consent/comply, previously treated with ≥1–2 lines including a proteasome inhibitor, lenalidomide (±pomalidomide), and an anti‑CD38 mAb, refractory to last line, measurable disease (serum M ≥0.5 g/dL, urine M ≥200 mg/24h, or involved FLC ≥10 mg/dL with abnormal ratio). Exclude: amyloidosis/MGUS/SMM/POEMS/plasma cell leukemia, prior anti‑BCMA, ≥grade 2 neuropathy, GBS/≥grade 3 motor neuropathy, SCT <12 weeks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single‑arm trial in relapsed/refractory multiple myeloma testing elranatamab (PF‑06863135) monotherapy. Drug/intervention: Elranatamab is a subcutaneous BCMA×CD3 bispecific IgG T‑cell–engaging antibody. Mechanism: One Fab binds BCMA (TNFRSF17) on malignant plasma cells, the other binds CD3 on endogenous T cells, forming an immune synapse that activates T cells (via TCR/CD3), induces cytokine release and cytotoxic granule delivery, and kills BCMA+ myeloma cells. Step‑up dosing (12 mg Day 1, 32 mg Day 4) then 76 mg weekly, switching to every‑other‑week with response. Cells/pathways targeted: BCMA on myeloma/plasma cells, BAFF/APRIL–BCMA survival axis, CD3/TCR signaling in T cells, downstream cytokine pathways (CRS/ICANS risk). Primary efficacy: MRD negativity at 6/12 months, safety includes CRS, ICANS, neurotoxicity, cytopenias, infections. Excludes prior anti‑BCMA.