Status:
AVAILABLE
Expanded Access Protocol (EAP) for Participants Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release
Lead Sponsor:
Celgene
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04771078
Last Update
December 12 2025
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