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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05201781
Registration number
NCT05201781
Ethics application status
Date submitted
10/01/2022
Date registered
21/01/2022
Date last updated
9/11/2023
Titles & IDs
Public title
A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
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Scientific title
Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
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Secondary ID [1]
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2020-005521-84
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Secondary ID [2]
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CR109123
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Cilta-cel
Experimental: Cilta-cel - Participants who had previously received treatment with cilta-cel in a Company-sponsored clinical study (example, NCT04923893, NCT03758417, NCT04181827, NCT05347485, 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 or a study has been terminated. 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.
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy
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Assessment method [1]
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Number of participants with new malignancies and recurrence of pre-existing malignancy will be reported.
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Timepoint [1]
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Up to 15 years
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Primary outcome [2]
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Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder
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Assessment method [2]
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Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder will be reported.
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Timepoint [2]
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Up to 15 years
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Primary outcome [3]
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Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder
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Assessment method [3]
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Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder will be reported.
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Timepoint [3]
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Up to 15 years
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Primary outcome [4]
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Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia
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Assessment method [4]
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Number of participants with new incidence of Grade >=3 hematologic disorder including hypogammaglobulinemia will be reported.
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Timepoint [4]
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From year 1 up to year 5
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Primary outcome [5]
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Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia
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Assessment method [5]
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Number of participants with serious hematologic disorder, including hypogammaglobulinemia will be reported. Serious hematologic disorder, includes hypogammaglobulinemia (all grades, regardless of causality).
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Timepoint [5]
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From year 6 up to year 15
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Primary outcome [6]
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Number of Participants with New Incidence of Grade >= 3 Infection
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Assessment method [6]
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Number of participants with new incidence of Grade >=3 infection will be reported.
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Timepoint [6]
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From year 1 up to year 5
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Primary outcome [7]
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Number of Participants with Serious Infection
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Assessment method [7]
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Number of participants with serious infection will be reported. Serious infection includes all grades, regardless of causality.
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Timepoint [7]
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From year 6 up to year 15
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Primary outcome [8]
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Number of Participants with Serious Adverse Events (SAEs)
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Assessment method [8]
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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.
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Timepoint [8]
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From year 1 up to year 5
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Primary outcome [9]
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Number of Participants with Related Serious Adverse Events Assessed by the Investigator
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Assessment method [9]
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Number of participants with related serious adverse events assessed by the investigator will be reported. 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.
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Timepoint [9]
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From year 6 up to year 15
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Secondary outcome [1]
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Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood
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Assessment method [1]
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Number of participants with measurable RCL in peripheral blood will be reported.
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Timepoint [1]
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Up to 15 years
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Secondary outcome [2]
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Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells
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Assessment method [2]
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Number of participants with CAR transgene level >LLOQ in peripheral blood cells will be reported.
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Timepoint [2]
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Up to 15 years
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Secondary outcome [3]
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Pattern of Lentiviral Vector Integration Sites
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Assessment method [3]
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Pattern of lentiviral vector integration sites if at least 1 percent (%) of cells in the blood sample or new malignancy are positive for vector sequences will be reported.
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Timepoint [3]
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Up to 15 years
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Secondary outcome [4]
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Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments
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Assessment method [4]
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Investigator's response assessment of long term follow-up on CAR-T therapy based on local lab assessments 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.
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Timepoint [4]
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Up to 15 years
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Secondary outcome [5]
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Overall Survival (OS)
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Assessment method [5]
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OS is measured from the date of randomization to the date of the participant's death.
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Timepoint [5]
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Up to 15 years
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Eligibility
Key inclusion criteria
- Participants who have received at least one dose of cilta-cel in a Company-sponsored
clinical study
- Participants who have provided informed consent for this study
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Other
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/03/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/07/2037
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Actual
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Sample size
Target
228
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Illinois
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Country [4]
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United States of America
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State/province [4]
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Indiana
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Country [5]
0
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
0
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United States of America
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State/province [6]
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Michigan
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Country [7]
0
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United States of America
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State/province [7]
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Minnesota
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Country [8]
0
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United States of America
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State/province [8]
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New Jersey
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Country [9]
0
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United States of America
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State/province [9]
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New York
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Country [10]
0
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United States of America
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State/province [10]
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North Carolina
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Country [11]
0
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United States of America
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State/province [11]
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Pennsylvania
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Country [12]
0
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United States of America
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State/province [12]
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Tennessee
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Country [13]
0
0
United States of America
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State/province [13]
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Wisconsin
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Country [14]
0
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Belgium
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State/province [14]
0
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Gent
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Country [15]
0
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Belgium
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State/province [15]
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Leuven
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Country [16]
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China
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State/province [16]
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Beijing
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Country [17]
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China
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State/province [17]
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Chengdu
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Country [18]
0
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China
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State/province [18]
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Fuzhou
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Country [19]
0
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China
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State/province [19]
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Hangzhou
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Country [20]
0
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China
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State/province [20]
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Nanjing
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Country [21]
0
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China
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State/province [21]
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Shanghai
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Country [22]
0
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China
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State/province [22]
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Xi'an
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Country [23]
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Israel
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State/province [23]
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Tel-Aviv
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Country [24]
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Japan
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State/province [24]
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Nagoya
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Country [25]
0
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Japan
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State/province [25]
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Shibuya
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Country [26]
0
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Netherlands
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State/province [26]
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Amsterdam
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Country [27]
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Netherlands
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State/province [27]
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Groningen
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Country [28]
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Spain
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State/province [28]
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Pamplona
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Country [29]
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Spain
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State/province [29]
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Salamanca
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05201781
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Study Contact
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Address
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Country
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Phone
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844-434-4210
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05201781
Download to PDF