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

Primary Investigator
Ghosh, Monalisa
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT04771078
UM Number
2023.075
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Bone Marrow Transplant
ID (Protocol)
32861
Secondary Protocol No
HUM00238344
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Multiple Myeloma
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.

Eligibility: 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/exclusion criteria apply