eligibility_summary
Adults (≥18) consenting, on teclistamab: first full dose 6–9 months pre-enrollment, average ≥1.5 mg/kg/month since first 1.5 mg/kg dose, with a dose within 4 weeks. Measurable MM per IMWG pre-initiation, achieved confirmed ≥VGPR to teclistamab and still responding. Prior PI, IMiD (len/pom), and anti-CD38, plus ≥3 prior lines or refractory to both PI and IMiD. ECOG 0–2 at start, 0–1 at enrollment. No systemic amyloidosis or POEMS.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05932680 tests limited-duration use of teclistamab in relapsed/refractory multiple myeloma. Intervention: patients with ≥VGPR after 6–9 months of standard teclistamab stop therapy and undergo off-drug surveillance, with teclistamab re-started at early progression. Drug/mechanism: Teclistamab is a BCMA×CD3 bispecific antibody (T‑cell engager) that binds BCMA (B‑cell maturation antigen, TNFRSF17) on malignant plasma cells and CD3 on T cells to redirect cytotoxic T‑cell killing of myeloma cells. Targets: BCMA-expressing plasma cells in the bone marrow and CD3 on T cells, activates T‑cell cytotoxic pathways and immune synapse formation, affecting the marrow microenvironment. Rationale: test whether stopping after deep response is non-inferior to continuous dosing, potentially reducing infections and BCMA-selective pressure (BCMA-negative escape). Exploratory: MRD, tumor features, marrow microenvironment biomarkers.