Multiple Myeloma
Conditions
Keywords
BB2121, Multiple Myeloma, Expanded Access, idecabtagene vicleucel, nonconforming, CAR T, EAP, Pre-Approval Access
Brief 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.
Interventions
BIOLOGICALNonconforming idecabtagene vicleucel
Nonconforming idecabtagene vicleucel is to be administered to participants after lymphodepleting chemotherapy
Sponsors
Celgene
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Had a participant-specific batch of Idecabtagene vicleucel (ide-cel) manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria * Remanufacturing is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the participant * Clinically stable
Exclusion criteria
* Has a hypersensitivity to the active substance or to any of the excipients * No experience of a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of Adverse Events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming Idecabtagene vicleucel (ide-cel) * Has any condition and/or laboratory abnormality that places the participant at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement Other protocol-defined inclusion/
Contacts
Primary ContactRecruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Backup ContactFirst line of the email MUST contain the NCT# and Site #.
Outcome results
None listed