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  • Cancer Type: Malignant Hematology
  • Study Type: Treatment
  • NCT#: NCT05346835
  • Phase: N/A
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  • Overview

    Study Title:

    Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (cilta-cel) Out-of-Specification (OOS) in Patients with Multiple Myeloma


    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.

  • Inclusion Criteria

      Inclusion Criteria:
    • 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
    • Able to provide informed consent indicating they understand the purpose of this expanded access program (EAP)
    • A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test during screening and prior to the first dose of cyclophosphamide and fludarabine
  • Exclusion Criteria

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