EXPANDED ACCESS PROTOCOL (EAP) FOR SUBJECTS RECEIVING IDECABTAGENE VICLEUCEL THAT IS NONCONFORMING FOR COMMERCIAL RELEASE

Sponsor:

Celgene

Sponsor Study ID:

bb2121-EAP-001

CTO #:

103362

NCT Number:

NCT04771078

Phase:

N/A

Protocol Type:

Treatment

Age Group:

Adults

Disease Sites:

Multiple Myeloma

Study Objectives:

This study is designed to evaluate the safety and efficacy of nonconforming idecabtagene vicleucel (ide-cel) in subjects 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.

eConsent:

Not available

Study Documents:

Open Study Documents
(MUSC NetID required for document access)

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