This study is designed to evaluate the safety and efficacy of nonconforming idecabtagene vicleucel (ide-cel) in subjects 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.
Biological: Nonconforming idecabtagene vicleucel
Nonconforming idecabtagene vicleucel is to be administered to subjects after lymphodepleting chemotherapy.
Other Name: BB2121
Inclusion Criteria: 1. Subject has multiple myeloma, 18 years of age or older and subject or legally authorized representative is able to sign the informed consent form. 2. Subject had a subject-specific batch of idecabtagene vicluecel manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria. The Sponsor has determined that the nonconforming idecabtagene vicleucel may be released for use under the Expanded Access Protocol. 3. Remanufacturing is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the subject. 4. Subject is clinically stable, has recovered from any prior toxicities prior to receiving lymphodepleting chemotherapy, and has adequate bone marrow function to receive lymphodepleting chemotherapy 5. Females of childbearing potential must: 1. Have a negative pregnancy test as verified by the treating physician within 7 days prior to the first dose of lymphodepleting chemotherapy following institutional testing methodology practices. This applies even if the subject practices true abstinence from heterosexual contact. 2. Either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, effective contraception without interruption. Contraception methods must include 1 highly effective method from screening until at least 12 months after the lymphodepleting chemotherapy. 3. Agree to abstain from breastfeeding during study participation and for at least 12 months following lymphodepleting chemotherapy. 4. There are insufficient exposure data to provide any recommendation concerning the duration of contraception and the abstaining from breastfeeding following treatment with nonconforming idecabtagene vicluecel. Any decision regarding contraception and breastfeeding after infusion should be discussed with the treating physician. 6. Male subjects must: 1. Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for at least 12 months after lymphodepleting chemotherapy even if the subject has undergone a successful vasectomy. 2. There are insufficient exposure data to provide any recommendation concerning the duration of contraception following treatment with nonconforming idecabtagene vicluecel. Any decision regarding contraception after infusion should be discussed with the treating physician.
Subject must agree to not donate blood, organs, tissue, sperm or semen and egg cells for
usage in other individuals for at least 1 year following lymphodepleting chemotherapy.
There are insufficient exposure data to provide any recommendation concerning the duration
of refraining from tissue donation following treatment with nonconforming idecabtagene
vicluecel. Therefore, participants treated with nonconforming idecabtagene vicluecel should
not donate blood, organs, tissues, and cells for transplantation.
Exclusion Criteria: 1. Subject has a hypersensitivity to the active substance or to any of the excipients. 2. Subject should not experience a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of AEs associated with lymphodepleting chemotherapy or exclude them from treatment with nonconforming idecabtagene vicluecel. 3. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness, sociologic or geographic condition that would prevent the subject from participating in the Expanded Access Protocol, complying with protocol requirements or confound the ability to interpret the data in the Investigator's judgement. 4. Subject has any condition and/or laboratory abnormality that places the subject at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement. 5. Pregnant or nursing women or has intention of becoming pregnant during the study.
Amit Agarwal, MD