Idecabtagene vicleucel (ide-cel) BCMA CAR-T for triple-class-exposed R/R multiple myeloma — single infusion after Flu/Cy lymphodepletion (KarMMa)
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
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.
| Components | None declared |
|---|
| ID | REG-IDECEL-MM-3L |
|---|---|
| Type | Regimen |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-KARMMA-MUNSHI-2021 SRC-NCCN-MM-2025 |
Notes
KarMMa (NCT03361748, Munshi NEJM 2021): single-infusion ide-cel (BCMA-directed CAR-T, 4-1BB costimulation, murine scFv) in heavily pretreated R/R multiple myeloma after ≥3 prior lines including PI + IMiD + anti-CD38 (n=128, median 6 prior lines). ORR 73% overall, 81% at 450×10⁶ dose; sCR 33%; mPFS 8.8 mo (450×10⁶ dose 12.1 mo); mOS 24.8 mo. KarMMa-3 (Rodriguez-Otero NEJM 2023, separate publication TODO source) expanded to 2L+ in triple-class-exposed patients with superior PFS vs standard triplet (mPFS 13.3 vs 4.4 mo). FDA approval Mar 2021 (3L+), expanded Apr 2024 (2L+ triple-class-exposed). Centre must be FACT/JACIE/REMS-accredited. Boxed warnings: CRS, ICANS, HLH/MAS, prolonged cytopenia, secondary T-cell malignancy (FDA 2024 class warning). Single curative-intent attempt; no maintenance. STUB — pending Co-Lead sign-off.
Used By
Indication
IND-MM-RR-3L-IDECEL- IND-MM-RR-3L-IDECEL
Regimen
REG-IDECEL-LYMPHODEPLETION-FLU-CY- Lymphodepleting fludarabine + cyclophosphamide conditioning before idecabtagene vicleucel...