eligibility_summary
Newly diagnosed MM, ≥4 induction cycles, HDT+ASCT within 12 months of induction start and ≤6 months post‑ASCT, PR or better, ECOG 0–2, post-ASCT consolidation allowed, ANC≥1.0×10^9/L, Hb≥85 g/L, PLT≥75×10^9/L (≥50×10^9/L if BMPC≥50%), no active infection, TBIL<1.5×ULN (≤3× in Gilbert), AST/ALT<3×ULN, CrCl≥45 mL/min. Exclude: refractory/intolerant to lenalidomide (Arm A) or lenalidomide+daratumumab (Arm B), prior MM progression, COPD FEV1<50%, moderate/severe persistent or uncontrolled asthma, stroke/thrombosis within 12 months.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06697483 tests MRD- and risk-stratified maintenance after ASCT in multiple myeloma. Interventions: 1) Lenalidomide—oral small‑molecule IMiD (immunotherapy). Mechanism: cereblon E3 ligase modulation → degradation of IKZF1/3, direct anti‑myeloma effects, enhances T‑cell/NK activity, antiangiogenic, modulates cytokines. 2) Daratumumab—anti‑CD38 IgG1 monoclonal antibody (immunotherapy). Mechanism: targets CD38 on plasma cells, mediates ADCC, CDC, ADCP, apoptosis, depletes CD38+ immunosuppressive cells. Targets/pathways: CD38+ malignant plasma cells, cereblon–IKZF1/3 axis, immune effector pathways (T/NK activation, complement) and marrow microenvironment. Assignment: R2‑ISS 1–2 & MRD‑negative → lenalidomide, R2‑ISS 3–4 or MRD‑positive → daratumumab + lenalidomide.