Phase Expanded Access
Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) in Patients With Multiple Myeloma
- Study HIC#:2000034539
- Last Updated:04/28/2024
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.
Contact Us
For more information about this study, including how to volunteer, contact:
Jialing Zhang
- Phone Number: 1-203-737-8884
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Eligibility 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
