A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma
Trial ID or NCT#
Status
Purpose
The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).
Official Title
A Safety and Efficacy Study of JNJ-68284528 (Ciltacabtagene Autoleucel) Out-of-Specification (OOS) for Commercial Release in Patients With Multiple Myeloma
Eligibility Criteria
- * 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Kristin Ana-Marie Muller
+1 650-725-1647
View on ClinicalTrials.gov