Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma
- Conditions
- Multiple Myeloma
- Registration Number
- NCT05346835
- Lead Sponsor
- Janssen Scientific Affairs, LLC
- 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 local health care system in the country where the treatment is requested.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- 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
Not provided
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (116)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Cancer Treatment Center of America Phoenix
🇺🇸Goodyear, Arizona, United States
HonorHealth Cancer Transplant Institute
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
The University of Arkansas for Medical Sciences Myeloma Institute for Research and Therapy
🇺🇸Little Rock, Arkansas, United States
City of Hope
🇺🇸Duarte, California, United States
University of California at San Diego
🇺🇸La Jolla, California, United States
USC Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Scroll for more (106 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States