Multiple Myeloma
Conditions
Interventions
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
Sponsors
Ei Fujikawa
Eligibility
Sex/Gender
All
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
Exclusion criteria
Exclusion criteria: N/A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Assess | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
China, Japan, United States of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed