eligibility_summary
Adults ≥18 with newly diagnosed multiple myeloma (one urgent bortezomib cycle allowed), measurable disease, ECOG ≤2, high‑risk cytogenetics and/or R‑ISS 3 or plasma cell leukemia, adequate marrow/organ function (ANC ≥1.0, platelets ≥70 [≥50 if marrow PCs ≥50%], liver tests ≤3×ULN, bilirubin ≤2×ULN, CrCl ≥40), negative pregnancy test/contraception, consent. Exclude MGUS/SMM/AL, recent/active cancer, uncontrolled illness, painful neuropathy, surgery <14d, major CV/pulmonary disease, HIV/HBV/HCV, CrCl <40, allergy, noncompliance, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm Phase 4 trial in high-risk newly diagnosed multiple myeloma. Regimen: 1 cycle VRd (bortezomib, lenalidomide, dexamethasone) for rapid control, then DKRD (daratumumab, carfilzomib, lenalidomide, dexamethasone) induction/consolidation ± ASCT, DKR maintenance, de-escalating to lenalidomide alone after ≥1 year sustained MRD negativity. Drugs/types/mechanisms: Daratumumab—anti-CD38 IgG1 monoclonal antibody, drives CDC, ADCC/ADCP and apoptosis, depleting CD38+ plasma and immunosuppressive cells. Carfilzomib—irreversible epoxyketone proteasome inhibitor (20S chymotrypsin-like). Bortezomib—reversible boronate proteasome inhibitor. Lenalidomide—IMiD, binds cereblon to degrade IKZF1/3, boosts T/NK function, anti-angiogenic. Dexamethasone—glucocorticoid, pro-apoptotic/anti-inflammatory. Targets/pathways: CD38, ubiquitin–proteasome system, cereblon–IKZF1/3–IRF4/MYC axis, immune effector (NK/T, complement), malignant plasma cells in marrow/extramedullary sites.