Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 68284528MMY4002 | Other Identifier | Janssen Research & Development, LLC | |
| 2020-005521-84 | EudraCT Number | ||
| 2023-505530-10-00 | Registry Identifier | EUCT number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cilta-cel | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilta-cel | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy | Number of participants with new malignancies and recurrence of pre-existing malignancy will be reported. | Up to 15 years |
| Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder | Number of participants with new incidence or exacerbation of a pre-existing neurologic disorder will be reported. | Up to 15 years |
| Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder | Number of participants with new incidence or exacerbation of a pre-existing rheumatologic or other autoimmune disorder will be reported. | Up to 15 years |
| Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia | Number of participants with new incidence of Grade >=3 hematologic disorder including hypogammaglobulinemia will be reported. | From year 1 up to year 5 |
| Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia | Number of participants with serious hematologic disorder, including hypogammaglobulinemia will be reported. Serious hematologic disorder, includes hypogammaglobulinemia (all grades, regardless of causality). | From year 6 up to year 15 |
| Number of Participants with New Incidence of Grade >= 3 Infection | Number of participants with new incidence of Grade >=3 infection will be reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood | Number of participants with measurable RCL in peripheral blood will be reported. | Up to 15 years |
| Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Cancer Center-Scottsdale | Recruiting | Phoenix | Arizona | 85054 | United States | |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| From year 1 up to year 5 |
| Number of Participants with Serious Infection | Number of participants with serious infection will be reported. Serious infection includes all grades, regardless of causality. | From year 6 up to year 15 |
| Number of Participants with Serious Adverse Events (SAEs) | 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. | From year 1 up to year 5 |
| Number of Participants with Related Serious Adverse Events Assessed by the Investigator | 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. | From year 6 up to year 15 |
Number of participants with CAR transgene level >LLOQ in peripheral blood cells will be reported. |
| Up to 15 years |
| Pattern of Lentiviral Vector Integration Sites | 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. | Up to 15 years |
| Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments | 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. | Up to 15 years |
| Overall Survival (OS) | OS is measured from the date of randomization to the date of the participant's death. | Up to 15 years |
| City of Hope |
| Recruiting |
| Duarte |
| California |
| 91010 |
| United States |
| University of California San Francisco | Recruiting | San Francisco | California | 94143 | United States |
| Stanford University Medical Center | Recruiting | Stanford | California | 94305-5623 | United States |
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
| Indiana University | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Kansas University Medical Center | Recruiting | Westwood | Kansas | 66205 | United States |
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02215 | United States |
| Barbara Ann Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
| Mayo Clinic Rochester | Recruiting | Rochester | Minnesota | 55902 | United States |
| Washington University School Of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
| Rutgers Cancer Institute of New Jersey | Recruiting | New Brunswick | New Jersey | 08903 | United States |
| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14263 | United States |
| Mount Sinai Medical Center | Recruiting | New York | New York | 10029 | United States |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10467 | United States |
| Levine Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Froedtert Memorial | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| UZ Gent | Recruiting | Ghent | 9000 | Belgium |
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
| Peking University Third Hospital | Active, not recruiting | Beijing | 100191 | China |
| West China Hospital Si Chuan University | Active, not recruiting | Chengdu | 610041 | China |
| Fujian Medical University Union Hospital | Active, not recruiting | Fuzhou | 350000 | China |
| Sun Yat-sen University Cancer Hospital | Active, not recruiting | Guangzhou | 510060 | China |
| First Hospital, Zhejiang University Medical College | Active, not recruiting | Hangzhou | 310003 | China |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School | Active, not recruiting | Nanjing | 210008 | China |
| Jiangsu Province Hospital | Active, not recruiting | Nanjing | 210029 | China |
| Shanghai Changzheng Hospital | Active, not recruiting | Shanghai | 200003 | China |
| Ruijin Hospital Shanghai Jiao Tong University | Active, not recruiting | Shanghai | 200025 | China |
| Shanghai Fourth People s Hospital | Active, not recruiting | Shanghai | 200434 | China |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Active, not recruiting | Xi'an | 710004 | China |
| CHRU de Lille Hopital Claude Huriez | Recruiting | Nord | 59037 | France |
| Hopital Saint Louis | Recruiting | Paris | 75010 | France |
| Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | 64239 | Israel |
| Nagoya City University Hospital | Active, not recruiting | Nagoya | 467 8602 | Japan |
| Japanese Red Cross Medical Center | Active, not recruiting | Shibuya City | 150-8935 | Japan |
| VU Medisch Centrum | Recruiting | Amsterdam | 1081 HV | Netherlands |
| University Medical Center Groningen | Recruiting | Groningen | 9713 GZ | Netherlands |
| Clinica Univ. de Navarra | Recruiting | Pamplona | 31008 | Spain |
| Hosp Clinico Univ de Salamanca | Recruiting | Salamanca | 37007 | Spain |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided