eligibility_summary
Adults 18–75 with primary plasma cell leukemia per IMWG and measurable disease, not candidates for upfront ASCT, BCMA-positive marrow, adequate organ function and blood counts, able to take prophylactic anticoagulants, contraception required. Exclude amyloidosis, CNS involvement, prior BCMA/CAR‑T, ≥grade 2 neuropathy, intolerance to study drugs, HIV/HBV/HCV, life expectancy <6 mo, pregnancy/breastfeeding, GI absorption issues, recent major surgery, live vaccine, or other contraindications/noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm study in transplant-ineligible primary plasma cell leukemia tests VRd induction (bortezomib, lenalidomide, dexamethasone) followed by autologous anti-BCMA CAR-T, then VR consolidation/maintenance. Mechanisms/types: • Bortezomib—small-molecule 26S proteasome inhibitor, induces proteotoxic stress, inhibits NF-κB, triggers plasma-cell apoptosis. • Lenalidomide—immunomodulatory drug (IMiD), binds cereblon E3 ligase to degrade IKZF1/3, downregulates IRF4/MYC, anti-proliferative/pro-apoptotic, enhances T/NK activity. • Dexamethasone—glucocorticoid, activates glucocorticoid receptor, induces lymphoid/plasma-cell apoptosis, anti-inflammatory. • Anti-BCMA CAR-T—autologous cellular immunotherapy, engineered T cells recognize BCMA (TNFRSF17) on malignant plasma cells and mediate cytotoxic killing. Targets: BCMA-positive plasma cells, pathways include ubiquitin–proteasome, NF-κB, cereblon–IKZF1/3–IRF4/MYC, glucocorticoid signaling, and T-cell cytotoxicity.