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Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma

Status
Active
Cancer Type
Multiple Myeloma
Trial Phase
Eligibility
18 Years and older, Male and Female
Study Type
NCT ID
NCT05346835
Protocol IDs
CR108968 (primary)
68284528MMY4006 ( Other Identifier ) (OTHER: Janss
Study Sponsor
Janssen Scientific Affairs, LLC

Objectives

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.

Eligibility

  • 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

Treatment Sites in Georgia

City of Hope Atlanta


600 Celebrate Life Parkway
Newnan, GA 30265
770-400-6169
www.cityofhope.org/locations/atlanta/atlanta-cancer-center

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