A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
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|ClinicalTrials.gov Identifier: NCT05201781|
Recruitment Status : Recruiting
First Posted : January 21, 2022
Last Update Posted : August 12, 2022
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Cilta-cel||Phase 4|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||228 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel|
|Actual Study Start Date :||March 9, 2022|
|Estimated Primary Completion Date :||July 29, 2037|
|Estimated Study Completion Date :||July 29, 2037|
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. 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.
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.
- Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 15 years ]Number of participants with new incidence of Grade >=3 hematologic disorder including hypogammaglobulinemia will be reported.
- Number of Participants with New Incidence of Grade >= 3 Infection [ Time Frame: Up to 15 years ]Number of participants with new incidence of Grade >=3 infection will be reported.
- Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 15 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 Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Up to 15 years ]OS is measured from the date of randomization to the date of the participant's death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05201781
|Contact: Study Contact||844-434-4210||Participate-In-This-Study@its.jnj.com|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|