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.

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

Multiple Myeloma

Kahler's Disease

Blood Cancer

Hematologic Neoplasms

Hematologic Malignancies

Hematology

Hematological Malignancies

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.

Cilta-cel

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

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 will be reported.

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 >=3 hematologic disorder including
hypogammaglobulinemia will be reported.

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 will be reported.

Number of participants with serious infection will be reported. Serious infection
includes all grades, regardless of causality.

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
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.

Number of participants with measurable RCL in peripheral blood will be reported.

Number of participants with CAR transgene level >LLOQ in peripheral blood cells will be
reported.

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 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.

OS is measured from the date of randomization to the date of the participant's death.

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.

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.

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.

Mayo Clinic Cancer Center-Scottsdale

City of Hope

University of California, San Francisco

University of Chicago

Beth Israel Deaconess Medical Center

Massachusetts General Hospital

Barbara Ann Karmanos Cancer Institute

Mayo Clinic Rochester

Rutgers Cancer Institute of New Jersey

Montefiore Medical Center

Roswell Park Cancer Institute

Mount Sinai Medical Center

Memorial Sloan Kettering Cancer Center

Levine Cancer Institute

University of Pennsylvania

University of Pittsburgh Medical Center

Sarah Cannon Research Institute

Froedtert Memorial

UZ Gent

UZ Leuven

Peking University Third Hospital

West China Hospital, Si Chuan University

Fujian Medical University Union Hospital

First Hospital, Zhejiang University Medical College

Jiangsu Province Hospital

Ruijin Hospital, Shanghai Jiao Tong University

Shanghai Fourth People's Hospital

The Second Affiliated Hospital of Xi'an Jiaotong University

Tel-Aviv Sourasky Medical Center

Nagoya City University Hospital

Japanese Red Cross Medical Center

VU Medisch Centrum

University Medical Center Groningen

Clinica Univ. de Navarra

Hosp. Clinico Univ. de Salamanca

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 will be reported.

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 >=3 hematologic disorder including hypogammaglobulinemia will be reported.

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 serious infection will be reported. Serious infection includes all grades, regardless of causality.

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 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.

Number of participants with CAR transgene level >LLOQ in peripheral blood cells will be reported.

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 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.

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.

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

Trials at a glance

Trials at a glance

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

Outcome measures

Primary outcome measures

Secondary outcome measures