Multiple Myeloma Clinical Trial
A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma
The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).
Eligible for treatment with cilta-cel per United States prescribing information (USPI) or locally approved label
Participant is suffering from serious or life threatening multiple myeloma per USPI (or locally approved label, respectively), and re-apheresis, re-manufacturing, or other anti-myeloma directed therapies is not considered feasible or adequate per investigator
Has adequate general health status and organ function per investigator assessment and meets the criteria to receive cilta-cel out-of-specifications (OOS)
Meets the criteria to receive lymphodepleting chemotherapy
A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test during screening and prior to the first dose of cyclophosphamide and fludarabine
History of active uncontrolled infection or condition where an administration of cilta-cel OOS constitutes serious health risk to the participant
Known allergies, hypersensitivity, or intolerance to the excipients of cilta-cel OOS including dimethyl sulfoxide (DMSO), dextran 40, or residual kanamycin per USPI
Hepatitis B infection
Hepatitis C infection defined as (anti hepatitis C virus [HCV] antibody positive or detectable HCV ribonucleic acid [RNA]) or known to have a history of hepatitis C
Seropositive for human immunodeficiency virus (HIV)
Uncontrolled autoimmune disease
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There are 18 Locations for this study
Duarte California, 91010, United States
San Francisco California, 94143, United States
Stanford California, 94305, United States
Denver Colorado, 80218, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Westwood Kansas, 66205, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Saint Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
New York New York, 10029, United States
New York New York, 10065, United States
Charlotte North Carolina, 28204, United States
Pittsburgh Pennsylvania, 15232, United States
Houston Texas, 77030, United States
Milwaukee Wisconsin, 53226, United States
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