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eligibility_summary
Eligible: ECOG ≤2, relapsed/refractory multiple myeloma, measurable disease (serum M‑protein ≥0.5 g/dL or urine ≥200 mg/24h, or FLC ≥100 mg/L with abnormal κ/λ ratio), ≥2 prior lines including PI, IMiD, and anti‑CD38 mAb, eligible for investigator’s choice standard therapy. Exclude: significant drug/alcohol abuse or major comorbidities in past 6 months, CNS MM, prior BCMA‑targeted therapy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3, randomized, open-label study in relapsed/refractory multiple myeloma comparing etentamig (ABBV-383) IV monotherapy vs investigator’s choice standard therapy (Kd, EloPd, or SVd). Etentamig: bispecific IgG-like T‑cell engager immunotherapy that binds BCMA on malignant plasma cells and CD3 on T cells, redirecting T‑cell cytotoxicity, targets BCMA+ myeloma cells and T‑cell activation. Standard regimens: carfilzomib (proteasome inhibitor, irreversibly inhibits 20S chymotrypsin-like activity), bortezomib (proteasome inhibitor), dexamethasone (glucocorticoid inducing lymphoid apoptosis), elotuzumab (anti‑SLAMF7 mAb activating NK cells and mediating ADCC against SLAMF7+ myeloma), pomalidomide (IMiD, cereblon-dependent IKZF1/3 degradation, immune stimulation), selinexor (XPO1 inhibitor, blocks nuclear export of tumor suppressors). Targets: BCMA+ plasma cells, CD3+ T cells, NK cells/SLAMF7, proteasome/ubiquitin pathway, XPO1 export, cereblon E3 ligase, glucocorticoid signaling.