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Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene autoleucel (cilta-cel) Out-of-Specification (OOS) in patients with Multiple Myeloma
Cancer Categories
Hematologic (Blood Cancers)
Karmanos Trial ID
2023-006
NCT ID
NCT05346835
Age Group
Adult
Scope
National
Phase
Questions, please contact us
N/A
Principal Investigator
Abhinav
Deol, M.D.
Oncology - Hematology, Oncology - Medical
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Objective:
Primary Objective:
Safety data reporting of Ciltacabtagene autoleucel (cilta-cel) Out-of-Specification (OOS)
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NCI Dictionary of Cancer Terms
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
Inclusion Criteria:
Eligible for treatment with cilta-cel per United States Prescribing Information (USPI)
Has serious or life-threatening multiple myeloma per USPI, and where re-apheresis, re-manufacturing, or other anti-myeloma directed therapy is not considered feasible or adequate per treating physician discretion
Favorable participant benefit/risk assessment determined by Janssen medical review
Treating physician confirms the favorable risk benefit profile, and that proceeding with this treatment is in the best interest of the participant
Able to provide informed consent indicating they understand the purpose of this expanded access program (EAP)
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
800-527-6266
Applicable Disease Site
Applicable Disease Site
Multiple Myeloma
Therapies, Drugs, Devices
Therapies | Drugs | Devices
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