Education and Training
Expanded Access Protocol (EAP) for Participants Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release
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.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- biological: Nonconforming idecabtagene vicleucel
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Meytra Brahman
650-725-1647
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