Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma
The purpose of this expanded access program (EAP) is to provide ciltacabtagene autoleucel (cilta-cel) that does not meet the commercial release specifications (cilta-cel out-of-specifications [OOS]) to appropriate adult participants (greater than or equal to 18 years) with relapsed/refractory multiple myeloma (MM).
|Condition or Disease||Intervention/Treatment||Phase|
Primary Outcome Measures
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)
Contacts and Locations
LocationsNo locations specified.
Sponsors and Collaborators
- Janssen Scientific Affairs, LLC
Study Documents (Full-Text)None provided.