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

JRCT ID: jRCT2033220220

Registered date:23/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Multiple Myeloma
• Date of first enrollment: 25/07/2022
• Target sample size: 228
• Countries of recruitment: China,Japan,United States of America,Japan
• Study type: Interventional

Intervention(s)

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.
Participants who had previously received treatment with cilta-cel in a Company-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 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.

Outcome(s)

Primary Outcome

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 : Up to 5 years : 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 : Up to 15 years : Number of participants with serioushematologic disorder, including hypogammaglobulinemia will be reported.

Number of Participants with New Incidence of Grade >= 3 Infection : Up to 5 years : Number of participants with new incidence of Grade >=3 infection will be reported.

Number of Participants with Serious Infection : Up to 15 years : Number of participants with serious infection will be reported.

Number of Participants with Serious Adverse Events (SAEs) : Up to 5 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.

Number of Participants with Related Serious Adverse Events Assessed by the Investigator : Up to 15 years : 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 Outcome

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 (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.

Overall Survival (OS) : Up to 15 years : OS is measured from the date of randomization to the date of the participant's death.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

• Exclude criteria: N/A

Related Information

• Primary Sponsor: Ei Fujikawa
• Secondary ID(s): NCT05201781