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History of Changes for Study: NCT05201781
A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Latest version (submitted November 3, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 10, 2022 None (earliest Version on record)
2 April 21, 2022 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 June 9, 2022 Outcome Measures, Study Status, Contacts/Locations, Eligibility and Arms and Interventions
4 July 14, 2022 Study Status and Contacts/Locations
5 July 27, 2022 Study Status and Contacts/Locations
6 August 11, 2022 Contacts/Locations and Study Status
7 September 8, 2022 Contacts/Locations and Study Status
8 October 5, 2022 Study Status and Contacts/Locations
9 November 3, 2022 Study Status and Contacts/Locations
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Study NCT05201781
Submitted Date:  January 10, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: CR109123
Brief Title: A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Official Title: Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Secondary IDs: 2020-005521-84 [EudraCT Number]
68284528MMY4002 [Janssen Research & Development, LLC]
Open or close this module Study Status
Record Verification: January 2022
Overall Status: Not yet recruiting
Study Start: January 21, 2022
Primary Completion: August 9, 2036 [Anticipated]
Study Completion: August 9, 2036 [Anticipated]
First Submitted: January 10, 2022
First Submitted that
Met QC Criteria:
January 10, 2022
First Posted: January 21, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
January 10, 2022
Last Update Posted: January 21, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Janssen Research & Development, LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The purpose of this study is to collect long-term follow-up data on delayed adverse events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel.
Detailed Description: Cilta-cel (JNJ-68284528/LCAR-B38M chimeric antigen receptor T-cells [CAR-T]) is an autologous CAR-T therapy that targets B-cell maturation antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells. There will be no treatment administered during the study and the data obtained from this study will help to assess whether there will be long-term cilta-cel-related toxicities. The study will consist of 2 phases: within the first 5 years after receiving the last dose of cilta-cel and Year 6 to 15 years after last dose of cilta-cel. Safety evaluations will include a review of adverse events, laboratory test results, and physical examination findings (including neurological examination). The duration of the study is up to 15 years after last dose of cilta-cel and participants will be followed at least once per year.
Open or close this module Conditions
Conditions: Multiple Myeloma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Phase 4
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 228 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Cilta-cel
Participants who had previously received treatment with cilta-cel in a Janssen-sponsored clinical study (example, NCT04923893, NCT04181827, NCT04133636, and NCT03548207) in the global development program will be enrolled into this study once the individual's participation in the particular interventional study has ended. Participants will not receive any treatment in this study and will be followed-up at least once per year on delayed adverse events for up to 15 years after receiving the last dose of cilta-cel.
Drug: Cilta-cel
Participants who had received cilta-cel in previous studies will be followed up in this study. No additional study treatment will be administered to participants in this study.
Other Names:
  • JNJ-68284528
  • LCAR-B38M CAR-T cells
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy
[ Time Frame: Up to 15 years ]

Number of participants with new malignancies and recurrence of pre-existing malignancy will be reported.
2. Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder
[ Time Frame: Up to 15 years ]

Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder will be reported.
3. Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder
[ Time Frame: Up to 15 years ]

Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder will be reported.
4. Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder
[ Time Frame: Up to 15 years ]

Number of participants with new incidence of Grade >=3 hematologic disorder will be reported.
5. Number of Participants with New Incidence of Grade >= 3 Infection
[ Time Frame: Up to 15 years ]

Number of participants with new incidence of Grade >=3 infection will be reported.
6. Number of Participants with Serious Adverse Events (SAEs)
[ Time Frame: Up to 15 years ]

A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Secondary Outcome Measures:
1. Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood
[ Time Frame: Up to 15 years ]

Number of participants with measurable RCL in peripheral blood will be reported.
2. Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells
[ Time Frame: Up to 15 years ]

Number of participants with CAR transgene level >LLOQ in peripheral blood cells will be reported.
3. Pattern of Vector Integration Sites
[ Time Frame: Up to 15 years ]

Pattern of vector integration sites if >1 percent (%) of cells in the blood sample or new malignancy are positive for vector sequences will be reported.
4. Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments
[ Time Frame: Up to 15 years ]

Investigator's response assessment of long term follow-up on CAR-T therapy based on local lab assessments (example, chemistry and complete blood count [CBC]) if the participant does not have confirmed disease progression or does not initiate subsequent anti-myeloma therapy at the entry of the study and at any time of during the study will be reported.
5. Overall Survival (OS)
[ Time Frame: Up to 15 years ]

OS is measured from the date of randomization to the date of the participant's death.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Participants who have received at least one dose of cilta-cel in a Janssen-sponsored clinical study
  • Participants who have provided informed consent for this study
Open or close this module Contacts/Locations
Central Contact Person: Study Contact
Telephone: 844-434-4210
Email: JNJ.CT@sylogent.com
Study Officials: Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Locations: United States, Arizona
Mayo Clinic Cancer Center-Scottsdale
Phoenix, Arizona, United States, 85054
United States, California
City of Hope
Duarte, California, United States, 91010
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55902
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Wisconsin
Froedtert Memorial
Milwaukee, Wisconsin, United States, 53226
China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China, 710004
Open or close this module IPDSharing
Plan to Share IPD: Yes
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Supporting Information:
Time Frame:
Access Criteria:
URL: https://www.janssen.com/clinical-trials/transparency
Open or close this module References
Citations:
Links:
Available IPD/Information:

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