Expanded Access Program for Patients Receiving Nonconforming Idecabtagene Vicleucel for Multiple Myeloma
Sponsor: Celgene
ClinicalTrials ID:NCT04771078
This program offers access to a version of the treatment idecabtagene vicleucel (ide-cel) for multiple myeloma patients, even if the treatment doesn't meet commercial standards but is still considered safe for investigational use.
Patient Parameters
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Program Overview
This program is designed to provide access to a version of the treatment idecabtagene vicleucel (ide-cel) for patients with multiple myeloma. The treatment may not meet the usual commercial standards but is still considered safe for use in this special program. The program is conducted at approved medical centers that are qualified to administer ide-cel and have authorization to use this nonconforming version.
Eligibility Criteria
Inclusion Criteria
- You had a batch of idecabtagene vicleucel (ide-cel) made specifically for you, but it didn't meet the usual commercial standards.
- Your doctor has determined that making a new batch is not possible or not appropriate for your situation.
- You are in stable health.
Exclusion Criteria
- You are allergic to the active ingredient or any other components of the treatment.
- You have not experienced a significant decline in health that would increase the risk of side effects from the chemotherapy used before ide-cel treatment.
- You do not have any health conditions or lab results that would put you at risk if you participate in this program, according to your doctor's assessment.
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