Cancer Clinical Trials
Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma
Learn moreWhat is the purpose of this study?
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
- 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
Where can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) in Patients With Multiple Myeloma
- Principal InvestigatorBenjamin H. Goldenson. MD
- Co-InvestigatorsRaghuveer Ranganathan, MD , Eduardo Fernandez Hernandez, MD
- Age GroupAdult, Older Adult
- ClinicalTrials.gov IDNCT05346835
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Lauren Wagner
lauren.wagner@hoag.org
Hoag Family Cancer Institute
Hoag Family Cancer Institute delivers advanced, compassionate cancer care across Orange County, with multidisciplinary specialists, precision therapies, support services, and access to 125+ cancer clinical trials. Patients benefit from research-driven care across a wide range of cancers, including breast, lung, gynecologic, prostate, gastrointestinal, and blood cancers.
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