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 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.
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.
Brief Title
Expanded Access Protocol (EAP) for Participants Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
please email:
Central Contact Email
Clinical.Trials@bms.com
Central Contact Role
Contact
Conditions
Multiple Myeloma
Eligibility Criteria
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
* 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
Inclusion Criteria
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
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
inclusion/
Gender
All
Gender Based
false
Keywords
BB2121
Multiple Myeloma
Expanded Access
idecabtagene vicleucel
nonconforming
CAR T
EAP
Pre-Approval Access
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04771078
Org Class
Industry
Org Full Name
Celgene
Org Study Id
BB2121-EAP-001
Overall Status
Available
Official Title
Expanded Access Protocol (EAP) for Patients Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release
Secondary Ids
Secondary Id
U1111-1263-0642
See Also Links
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ridhi Gupta
Investigator Email
ridgupta@montefiore.org
Investigator Department
Medicine
Investigator Division
Oncology
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology
Categories Mesh Debug
Blood & Bone Marrow Cancers --- MULTIPLE MYELOMA
Blood & Bone Marrow Cancers --- NEOPLASMS, PLASMA CELL
Cancer --- NEOPLASMS
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Blood Disorders --- HEMATOLOGIC DISEASES
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
MeSH Terms
MULTIPLE MYELOMA
NEOPLASMS, PLASMA CELL
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
HEMOSTATIC DISORDERS
VASCULAR DISEASES
CARDIOVASCULAR DISEASES
PARAPROTEINEMIAS
BLOOD PROTEIN DISORDERS
HEMATOLOGIC DISEASES
HEMIC AND LYMPHATIC DISEASES
HEMORRHAGIC DISORDERS
LYMPHOPROLIFERATIVE DISORDERS
IMMUNOPROLIFERATIVE DISORDERS
IMMUNE SYSTEM DISEASES
IDECABTAGENE VICLEUCEL