The purpose of this expanded access program (EAP) is to provide ciltacabtagene autoleucel (cilta-cel) that does not meet the commercial release specifications of CARVYKTI and is not available via the local health care system in the country where the treatment is requested.
Eligible for treatment with cilta-cel per United States Prescribing Information (USPI)
Has serious or life-threatening multiple myeloma per USPI, and where re-apheresis, re-manufacturing, or other anti-myeloma directed therapy is not considered feasible or adequate per treating physician discretion
Favorable participant benefit/risk assessment determined by Janssen medical review
Treating physician confirms the favorable risk benefit profile, and that proceeding with this treatment is in the best interest of the participant
None
Cilta-cel OOS Therapy
DrugCiltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) will be provided as a one-time administration as an intravenous infusion.
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