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.
Brief Title
A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
844-434-4210
Central Contact Email
Participate-In-This-Study1@its.jnj.com
Completion Date
Completion Date Type
Estimated
Conditions
Multiple Myeloma
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05201781
Org Class
Industry
Org Full Name
Janssen Research & Development, LLC
Org Study Id
CR109123
Overall Status
Recruiting
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Primary Outcomes
Outcome Description
Number of participants with new malignancies and recurrence of pre-existing malignancy will be reported.
Outcome Measure
Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy
Outcome Time Frame
Up to 15 years
Outcome Description
Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder will be reported.
Outcome Measure
Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder
Outcome Time Frame
Up to 15 years
Outcome Description
Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder will be reported.
Outcome Measure
Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder
Outcome Time Frame
Up to 15 years
Outcome Description
Number of participants with new incidence of Grade \>=3 hematologic disorder including hypogammaglobulinemia will be reported.
Outcome Measure
Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia
Outcome Time Frame
From year 1 up to year 5
Outcome Description
Number of participants with serious hematologic disorder, including hypogammaglobulinemia will be reported. Serious hematologic disorder, includes hypogammaglobulinemia (all grades, regardless of causality).
Outcome Measure
Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia
Outcome Time Frame
From year 6 up to year 15
Outcome Description
Number of participants with new incidence of Grade \>=3 infection will be reported.
Outcome Measure
Number of Participants with New Incidence of Grade >= 3 Infection
Outcome Time Frame
From year 1 up to year 5
Outcome Description
Number of participants with serious infection will be reported. Serious infection includes all grades, regardless of causality.
Outcome Measure
Number of Participants with Serious Infection
Outcome Time Frame
From year 6 up to year 15
Outcome Description
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.
Outcome Measure
Number of Participants with Serious Adverse Events (SAEs)
Outcome Time Frame
From year 1 up to year 5
Outcome Description
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.
Outcome Measure
Number of Participants with Related Serious Adverse Events Assessed by the Investigator
Outcome Time Frame
From year 6 up to year 15
Secondary Ids
Secondary Id
68284528MMY4002
Secondary Id
2020-005521-84
Secondary Id
2023-505530-10-00
Secondary Outcomes
Outcome Description
Number of participants with measurable RCL in peripheral blood will be reported.
Outcome Time Frame
Up to 15 years
Outcome Measure
Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood
Outcome Description
Number of participants with CAR transgene level \>LLOQ in peripheral blood cells will be reported.
Outcome Time Frame
Up to 15 years
Outcome Measure
Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells
Outcome Description
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.
Outcome Time Frame
Up to 15 years
Outcome Measure
Pattern of Lentiviral Vector Integration Sites
Outcome Description
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.
Outcome Time Frame
Up to 15 years
Outcome Measure
Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments
Outcome Description
OS is measured from the date of randomization to the date of the participant's death.
Outcome Time Frame
Up to 15 years
Outcome Measure
Overall Survival (OS)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ridhi Gupta
Investigator Email
ridgupta@montefiore.org