A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma
NCT ID: NCT05347485
Last Updated: 2025-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
86 participants
INTERVENTIONAL
2022-05-13
2023-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ciltacabtagene Autoleucel (Cilta-cel)
Eligible participants will receive bridging therapy (that is, anti-plasma cell directed treatment) based on participant's clinical status and timing of availability of cilta-cel (JNJ-68284528) along with lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] and fludarabine 30 mg/m\^2 IV daily, for 3 days). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants will receive a single IV infusion of cilta-cel (JNJ-68284528) at a total targeted dose of 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (cells/kg).
Cilta-cel
Cilta-cel will be administered as an IV infusion.
Lymphodepleting Therapy (Cyclophosphamide and Fludarabine)
Lymphodepleting therapy (cyclophosphamide and fludarabine) will be administered intravenously.
Interventions
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Cilta-cel
Cilta-cel will be administered as an IV infusion.
Lymphodepleting Therapy (Cyclophosphamide and Fludarabine)
Lymphodepleting therapy (cyclophosphamide and fludarabine) will be administered intravenously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Janssen Scientific Affairs, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Scientific Affairs, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Scientific Affairs, LLC
Locations
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City of Hope
Duarte, California, United States
University of California San Francisco
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Kansas University Medical Center
Westwood, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Mount Sinai Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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68284528MMY2005
Identifier Type: OTHER
Identifier Source: secondary_id
CR109014
Identifier Type: -
Identifier Source: org_study_id
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