Expanded Access Protocol (EAP) for Subjects Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release
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|ClinicalTrials.gov Identifier: NCT04771078|
Expanded Access Status : Available
First Posted : February 25, 2021
Last Update Posted : July 30, 2021
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.
|Condition or disease||Intervention/treatment|
|Multiple Myeloma||Biological: Nonconforming idecabtagene vicleucel|
|Study Type :||Expanded Access|
|Expanded Access Type :||Intermediate-size Population|
|Official Title:||Expanded Access Protocol (EAP) for Patients Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release|
- Biological: Nonconforming idecabtagene vicleucel
Nonconforming idecabtagene vicleucel is to be administered to subjects after lymphodepleting chemotherapy.Other Name: BB2121
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04771078
|Contact: Associate Director Clinical Trial Disclosurefirstname.lastname@example.org|
|Study Director:||Amit Agarwal, MD||Bristol-Myers Squibb|