eligibility_summary
Adults ≥18 with NDMM and measurable disease, ineligible for upfront ASCT (≥70, 18–69 with comorbidities/guidelines, or refuse), ECOG 0–2, adequate organs, contraception per protocol, WOCBP 2 negative tests. Exclude AL amyloidosis, Waldenström, POEMS, primary PCL, prior MM tx, CNS involvement, active liver dz, high CV risk, uncontrolled HIV, active HBV/HCV, other cancers unless stable ≥2y, corneal dz, cannot take antiviral/antithrombotics, belantamab allergy, recent plasmapheresis, live vaccine ≤30d.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3, randomized, open‑label trial in transplant‑ineligible newly diagnosed multiple myeloma comparing: 1) BRd: belantamab mafodotin + lenalidomide + dexamethasone vs 2) DRd: daratumumab + lenalidomide + dexamethasone. Interventions and mechanisms: • Belantamab mafodotin: antibody‑drug conjugate (ADC) targeting BCMA on malignant plasma cells, delivers the microtubule inhibitor MMAF to induce apoptosis, also engages immune effector functions (e.g., ADCC/ADCP). • Daratumumab: anti‑CD38 IgG1 monoclonal antibody causing ADCC, CDC, ADCP, and direct apoptosis, depletes CD38+ immunosuppressive cells. • Lenalidomide: immunomodulatory drug (IMiD) binding cereblon, promoting IKZF1/3 degradation, enhances T/NK activity and anti‑myeloma cytotoxicity, anti‑angiogenic. • Dexamethasone: glucocorticoid inducing lymphoid apoptosis and anti‑inflammatory effects. Targets/pathways: BCMA+ plasma cells, CD38+ myeloma and immune cells, cereblon–IKZF1/3 axis, microtubules, immune effector pathways. Primary aims: PFS and MRD negativity.