Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Expanded Access Protocol (EAP) for Subjects Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04771078
Expanded Access Status : Available
First Posted : February 25, 2021
Last Update Posted : July 30, 2021
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

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.


Condition or disease Intervention/treatment
Multiple Myeloma Biological: Nonconforming idecabtagene vicleucel

Layout table for study information
Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
Official Title: Expanded Access Protocol (EAP) for Patients Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release



Intervention Details:
  • Biological: Nonconforming idecabtagene vicleucel
    Nonconforming idecabtagene vicleucel is to be administered to subjects after lymphodepleting chemotherapy.
    Other Name: BB2121

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04771078


Contacts
Layout table for location contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@bms.com

Locations
Show Show 78 study locations
Sponsors and Collaborators
Celgene
Investigators
Layout table for investigator information
Study Director: Amit Agarwal, MD Bristol-Myers Squibb
Layout table for additonal information
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04771078    
Other Study ID Numbers: BB2121-EAP-001
U1111-1263-0642 ( Registry Identifier: WHO )
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: July 30, 2021
Last Verified: July 2021
Keywords provided by Celgene:
BB2121
Multiple Myeloma
Expanded Access
idecabtagene vicleucel
nonconforming
CAR T
EAP
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases