Status:
AVAILABLE
Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma
Lead Sponsor:
Janssen Scientific Affairs, LLC
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05346835
Last Update
August 27 2025
Active Locations (117)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
3
Cancer Treatment Center of America Phoenix
Goodyear, Arizona, United States, 85338
4
HonorHealth Cancer Transplant Institute
Scottsdale, Arizona, United States, 85258