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Expanded Access Protocol for Receiving Idecabtagene Vicleucel That is Nonconforming for commercial

Updated: Sep 27

NCT04771078: Expanded Access Protocol (EAP) for Participants Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release

Expanded Access Protocol Idecabtagene Vicleucel

Expanded Access Protocol (EAP) for Participants Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release


This study is designed to evaluate the safety and efficacy of nonconforming idecabtagene vicleucel (ide-cel) in participants with multiple myeloma per the approved prescribing information. This is an expanded access protocol (EAP) to be conducted at Risk Evaluation and Mitigation Strategies (REMS) qualified sites approved for commercial administration of idecabtagene vicleucel and where the EAP is authorized to be conducted for use of nonconforming idecabtagene vicleucel.


Non-conforming idecabtagene vicluecel is idecabtagene vicleucel that does not meet commercial release specifications but may be acceptable for use as an investigational product in the Expanded Access Protocol setting.


Sponsor

Celgene

 

ClinicalTrials.gov Identifier: NCT04771078


Official Title: Expanded Access Protocol (EAP) for Subjects Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release

First Posted: February 25, 2021


Click here to see details on ClinicalTrials.gov

 

Biological: Nonconforming idecabtagene vicleucel

 





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