Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
N/A
Funding Agency/Sponsor
Industrial
Disease
Lymphoma
Enrollment 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