What is the Purpose of this Study?
Primary Objective: 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. Secondary Objectives: N/A
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
Where can I participate?
CS Cancer at Cedars-Sinai Medical Center : Amy Oppenheim
More about this Clinical Trial
What is the full name of this clinical trial?
68284528MMY4006 Intermediate-size population Expended Access Program for ciltacabtagene autoleucel out-of-specification in patients with multiple myeloma *