A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel

Study Overview
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Brief Summary
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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
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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.

Official Title
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Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Cilta-cel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cilta-cel<br>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. | Drug: Cilta-cel<br>* 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.<br>* Other names: LCAR-B38M CAR-T cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy | Number of participants with new malignancies and recurrence of pre-existing malignancy will be reported. | Up to 15 years | 
| Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder | Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder will be reported. | Up to 15 years | 
| Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder | Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder will be reported. | Up to 15 years | 
| Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia | Number of participants with new incidence of Grade >=3 hematologic disorder including hypogammaglobulinemia will be reported. | From year 1 up to year 5 | 
| Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia | Number of participants with serious hematologic disorder, including hypogammaglobulinemia will be reported. Serious hematologic disorder, includes hypogammaglobulinemia (all grades, regardless of causality). | From year 6 up to year 15 | 
| Number of Participants with New Incidence of Grade >= 3 Infection | Number of participants with new incidence of Grade >=3 infection will be reported. | From year 1 up to year 5 | 
| Number of Participants with Serious Infection | Number of participants with serious infection will be reported. Serious infection includes all grades, regardless of causality. | From year 6 up to year 15 | 
| Number of Participants with Serious Adverse Events (SAEs) | 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. | From year 1 up to year 5 | 
| Number of Participants with Related Serious Adverse Events Assessed by the Investigator | 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. | From year 6 up to year 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood | Number of participants with measurable RCL in peripheral blood will be reported. | Up to 15 years | 
| Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells | Number of participants with CAR transgene level >LLOQ in peripheral blood cells will be reported. | Up to 15 years | 
| Pattern of Lentiviral Vector Integration Sites | 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. | Up to 15 years | 
| Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments | 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. | Up to 15 years | 
| Overall Survival (OS) | OS is measured from the date of randomization to the date of the participant's death. | Up to 15 years |