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Ciltacabtagene autoleucel (cilta-cel) BCMA CAR-T for lenalidomide-refractory R/R multiple myeloma after 1-3 prior lines — single infusion after Flu/Cy lymphodepletion (CARTITUDE-4)

Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.

Contenu clinique provisoire : il ne s'agit pas d'une ordonnance. Un oncologue doit vérifier les sources originales, l'applicabilité et le statut de révision.

Source YAML: dossier complet

ComposantesAucune déclaration
IDREG-CILTACEL-MM-2L
TypeProtocole thérapeutique
Étatreviewed 2026-04-29 | pending_clinical_signoff
MaladiesAucune déclaration
SourcesSRC-CARTITUDE-1-BERDEJA-2021 SRC-NCCN-MM-2025

Notes

CARTITUDE-4 (NCT04181827, San-Miguel NEJM 2023, PMID 37272512): randomized phase-3 of single-infusion cilta-cel vs investigator's choice (PVd or DPd) in lenalidomide-refractory R/R multiple myeloma after 1-3 prior lines (n=419, 1:1 randomization). Cilta-cel arm: ORR 84.6%, sCR 73.1%; mPFS not reached vs 11.8 mo control (HR 0.26, p<0.001); 12-mo PFS 75.9% vs 48.6%. Established cilta-cel as superior to standard-of-care triplets in lenalidomide-refractory 2L+ MM. FDA approval Apr 2024 (this 2L indication). MNT mitigation strategies (low tumor burden via bridging, prompt CRS/ICANS rx) reduced delayed-onset neurotoxicity from ~5% (CARTITUDE-1) to ~1% (CARTITUDE-4). Centre must be FACT/JACIE/REMS-accredited. Boxed warnings unchanged from CARTITUDE-1 (CRS, ICANS, MNT, HLH/MAS, prolonged cytopenia, secondary T-cell malignancy). Single curative-intent attempt; no maintenance. STUB — pending Co-Lead sign-off. Bibliographic record SRC-CARTITUDE-4-SAN-MIGUEL-2023 (NEJM PMID 37272512) is available; source-to-claim mapping, including trial-design and safety context, requires dual clinical review.

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Indication

Protocole thérapeutique