Status:
COMPLETED
A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma
Lead Sponsor:
Janssen Scientific Affairs, LLC
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT05347485
Start Date
May 13 2022
End Date
December 15 2023
Last Update
April 25 2025
Active Locations (18)
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1
City of Hope
Duarte, California, United States, 91010
2
University of California San Francisco
San Francisco, California, United States, 94143
3
Stanford University Medical Center
Stanford, California, United States, 94305
4
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218