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

Primary Investigator
Ghosh, Monalisa
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT05346835
UM Number
2023.041
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Bone Marrow Transplant
ID (Protocol)
45855
Secondary Protocol No
HUM00233068
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Multiple Myeloma
Summary
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: 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