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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)

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Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.

Source YAML: complete record

ComponentsNone declared
IDREG-CILTACEL-MM-2L
TypeRegimen
Statusreviewed 2026-04-29 | pending_clinical_signoff
DiseasesNone declared
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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