eligibility_summary
Eligible: adults 18–70 with newly diagnosed ultra high‑risk MM (double‑hit ≥2 adverse markers, extramedullary MM, or primary plasma cell leukemia), untreated or no prior systemic MM therapy, transplant‑fit, ECOG ≤2. Exclude: not high‑risk/other plasma cell disorders, prior MM therapy, other invasive cancers, key drug allergies, thromboprophylaxis contraindication, major cardiac/pulmonary disease, severe cytopenias, renal/hepatic dysfunction, HIV/HBV/HCV, pregnancy, recent investigational drug or major surgery, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm trial in ultra high-risk, newly diagnosed, transplant-eligible multiple myeloma (including pPCL and EMM) tests a daratumumab + carfilzomib-based program with ASCT: induction Dara-KRd-PACE (optional pretrial VCD), ASCT (melphalan), consolidation Dara-KRd, maintenance Dara-Kd. Drug types/mechanisms: daratumumab - anti-CD38 monoclonal antibody mediating plasma-cell killing via ADCC/CDC/ADCP and apoptosis, carfilzomib - irreversible 20S proteasome inhibitor causing proteotoxic/ER-stress apoptosis, lenalidomide - IMiD/cereblon modulator degrading IKZF1/3 and boosting T and NK immunity, dexamethasone - glucocorticoid, lympholytic, cisplatin and melphalan - DNA crosslinking/alkylating agents, epirubicin - anthracycline, topo II inhibitor, cyclophosphamide - alkylator, etoposide - topo II poison, bortezomib - reversible proteasome inhibitor. Targets/pathways: CD38-positive malignant plasma cells, ubiquitin-proteasome system, cereblon/IKZF, DNA damage/repair and topo II pathways, and immune effector cytotoxicity.