Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma
Overview
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.
Who Can Participate
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
Disclaimer
This summary is based on publicly available information from clinicaltrials.gov and is intended to help patients discuss possible trial options with their oncology care team. ClinicalTrials.gov and related public listings do not independently review or approve the safety and scientific merit of every study.
Participation decisions can be made only after review by the study team and your treating clinician.