eligibility_summary
Key inclusion: adults 18–65 with untreated primary PCL, ECOG 0–2, ≥3‑mo life expectancy, measurable MM (M‑protein or FLC), BCMA+ marrow, adequate counts (ANC≥1.0, PLT≥50) and organ function (bilirubin<1.5×ULN, CrCl≥50), able to take anticoagulation and use contraception, consent/compliance. Key exclusion: secondary PCL, CNS disease, ASCT‑ineligible, intolerance to study drugs, recent major surgery, significant CV disease, HIV, active HBV/HCV/infection, other cancers <5y, pregnancy/breastfeeding, GI issues, conflicting meds/trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm phase II trial in newly diagnosed primary plasma cell leukemia testing VRD plus sequential BCMA CAR-T and ASCT (CART–ASCT–CART2). Interventions/mechanisms: • Bortezomib (proteasome inhibitor): blocks 26S proteasome, inducing plasma-cell stress and apoptosis. • Lenalidomide (IMiD): binds cereblon to degrade Ikaros/Aiolos, inhibiting myeloma growth and enhancing T/NK-cell activity, used for maintenance post-ASCT. • Dexamethasone (glucocorticoid): glucocorticoid receptor–mediated cytotoxic and anti-inflammatory effects. • Autologous anti-BCMA CAR-T cells: engineered T cells targeting BCMA on plasma cells, given twice (before and after ASCT). • ASCT: cytoreductive consolidation. Targets/pathways: BCMA/TNFRSF17 on malignant plasma cells, ubiquitin–proteasome pathway, cereblon-mediated transcriptional program, glucocorticoid receptor signaling, cytotoxic T-cell immunity against BCMA+ cells.