eligibility_summary
Eligible: NDMM per IMWG, planned high-dose therapy + ASCT, measurable disease (central lab: M-protein >=1 g/dL serum or >=200 mg/24h urine, or FLC >=10 mg/dL with abnormal ratio), ECOG 0-1, labs in range. Exclude: prior CAR-T, BCMA therapy, or other MM therapy (except brief steroids), strong CYP3A4 inducer within 5 half-lives, live attenuated vaccine (except COVID-19) within 4 weeks, CNS myeloma, stroke/seizure within 6 months.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 trial in transplant-eligible newly diagnosed multiple myeloma compares: (A) DVRd induction → ASCT → DVRd consolidation → lenalidomide maintenance vs (B) DVRd induction → lymphodepletion (cyclophosphamide+fludarabine) → ciltacabtagene autoleucel (cilta-cel) → lenalidomide maintenance. Interventions and mechanisms: Cilta-cel: autologous BCMA-targeted CAR-T, T cells kill BCMA+ malignant plasma cells. Daratumumab: anti-CD38 monoclonal antibody, depletes CD38+ myeloma cells via ADCC/CDC/apoptosis and immune modulation. Bortezomib: 26S proteasome inhibitor, disrupts ubiquitin-proteasome/NF-kB signaling causing ER stress/apoptosis. Lenalidomide: IMiD, binds cereblon, degrades IKZF1/3, boosts T/NK activity. Dexamethasone: corticosteroid, lympholytic/pro-apoptotic via glucocorticoid receptor. Cyclophosphamide (alkylator) and fludarabine (purine analog): lymphodepleting chemo to aid CAR-T expansion. ASCT: high-dose chemo with stem-cell rescue. Targets: BCMA+ plasma cells, CD38, proteasome, cereblon-IKZF axis, glucocorticoid signaling, T/NK effector pathways.