Expanded Access Protocol (EAP) for Participants Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04771078|
Expanded Access Status : Available
First Posted : February 25, 2021
Last Update Posted : February 8, 2022
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.
|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 Subjects Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release|
- Biological: Nonconforming idecabtagene vicleucel
Nonconforming idecabtagene vicleucel is to be administered to participants after lymphodepleting chemotherapyOther 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: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,||please email:||Clinical.Trials@bms.com|
|Contact: First line of the email MUST contain the NCT# and Site #.|
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|