eligibility_summary
Inclusion: newly diagnosed MM, no prior therapy, R-ISS I–II (standard risk), IMWG frailty 0–1, measurable disease (M-protein: serum ≥1 g/dL or urine ≥200 mg/24h, or LC MM with FLC ≥10 mg/dL + abnormal ratio), ECOG 0–1. Exclusion: MDS/other B-cell cancer or other malignancy needing systemic therapy, peripheral neuropathy ≥2, CNS disease, stroke/seizure <6 mo, plasma cell leukemia/WM/POEMS/AL amyloidosis, high-risk cytogenetics (del17p, t(4,14), t(14,16), amp1q≥4) or extramedullary disease, HIV+.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 trial in standard-risk newly diagnosed multiple myeloma tests two sequences after DVRd induction: (A) 4 cycles DVRd → talquetamab+daratumumab consolidation → lymphodepletion (cyclophosphamide/fludarabine) → cilta-cel, or (B) DVRd → lymphodepletion → cilta-cel → alternating talquetamab+daratumumab and teclistamab+daratumumab. Drug types/mechanisms: Cilta-cel = autologous anti-BCMA CAR-T (engineered T-cell therapy). Talquetamab = GPRC5D×CD3 bispecific T-cell–redirecting antibody. Teclistamab = BCMA×CD3 bispecific T-cell–redirecting antibody. Daratumumab = anti-CD38 monoclonal antibody (ADCC/CDC/phagocytosis). Bortezomib = proteasome inhibitor. Lenalidomide = IMiD (cereblon E3 modulator degrading IKZF1/3, immune activation). Dexamethasone = corticosteroid. Cyclophosphamide/Fludarabine = lymphodepleting cytotoxic chemo. Targets/pathways: plasma cells expressing BCMA, GPRC5D, CD38, CD3-driven T-cell cytotoxicity, proteasome, cereblon–IKZF/IRF4–MYC axis, glucocorticoid apoptosis, DNA damage/lymphodepletion.