NCT04771078

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

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

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Nonconforming idecabtagene vicleucel	Nonconforming idecabtagene vicleucel is to be administered to participants after lymphodepleting chemotherapy

Timeline

• First posted: 2021-02-25
• Last updated: 2025-12-12