Multiple Myeloma
Conditions
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.
Interventions
DRUGCilta-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.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy | Up to 15 years | Number of participants with new malignancies and recurrence of pre-existing malignancy will be reported. |
| Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder | Up to 15 years | Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder will be reported. |
| Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder | Up to 15 years | Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder will be reported. |
| Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia | From year 1 up to year 5 | Number of participants with new incidence of Grade \>=3 hematologic disorder including hypogammaglobulinemia will be reported. |
| Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia | From year 6 up to year 15 | Number of participants with serious hematologic disorder, including hypogammaglobulinemia will be reported. Serious hematologic disorder, includes hypogammaglobulinemia (all grades, regardless of causality). |
| Number of Participants with New Incidence of Grade >= 3 Infection | From year 1 up to year 5 | Number of participants with new incidence of Grade \>=3 infection will be reported. |
| Number of Participants with Serious Infection | From year 6 up to year 15 | Number of participants with serious infection will be reported. Serious infection includes all grades, regardless of causality. |
| Number of Participants with Serious Adverse Events (SAEs) | From year 1 up to year 5 | 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. |
| Number of Participants with Related Serious Adverse Events Assessed by the Investigator | From year 6 up to year 15 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood | Up to 15 years | Number of participants with measurable RCL in peripheral blood will be reported. |
| Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells | Up to 15 years | Number of participants with CAR transgene level \>LLOQ in peripheral blood cells will be reported. |
| Pattern of Lentiviral Vector Integration Sites | Up to 15 years | 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. |
| Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments | Up to 15 years | 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. |
| Overall Survival (OS) | Up to 15 years | OS is measured from the date of randomization to the date of the participant's death. |
Countries
Belgium, China, France, Israel, Japan, Netherlands, Spain, United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed