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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05201781
• Other study ID #: CR109123
• Secondary ID: 2020-005521-8468
• Status: Recruiting
• Phase: Phase 4
• Start date: March 9, 2022
• Est. completion date: July 29, 2037

Study information

• Verified date: March 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: July 29, 2037
• Est. primary completion date: July 29, 2037
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Belgium	UZ Gent	Gent
Belgium	UZ Leuven	Leuven
China	Peking University Third Hospital	Beijing
China	West China Hospital, Si Chuan University	Chengdu
China	Fujian Medical University Union Hospital	Fuzhou
China	First Hospital, Zhejiang University Medical College	Hangzhou
China	Jiangsu Province Hospital	Nanjing
China	Ruijin Hospital, Shanghai Jiao Tong University	Shanghai
China	Shanghai Fourth People's Hospital	Shanghai
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv
Japan	Nagoya City University Hospital	Nagoya
Japan	Japanese Red Cross Medical Center	Shibuya
Netherlands	VU Medisch Centrum	Amsterdam
Netherlands	University Medical Center Groningen	Groningen
Spain	Clinica Univ. de Navarra	Pamplona
Spain	Hosp. Clinico Univ. de Salamanca	Salamanca
United States	Emory University	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	City of Hope	Duarte	California
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	MD Anderson Cancer Center	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Froedtert Memorial	Milwaukee	Wisconsin
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic Cancer Center-Scottsdale	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of California San Francisco	San Francisco	California
United States	Kansas University Medical Center	Westwood	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Belgium,  China,  Israel,  Japan,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of Participants with New Incidence of Grade >= 3 Infection	Number of participants with new incidence of Grade >=3 infection will be reported.	From year 1 up to year 5
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells	Number of participants with CAR transgene level >LLOQ in peripheral blood cells will be reported.	Up to 15 years
Secondary	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
Secondary	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
Secondary	Overall Survival (OS)	OS is measured from the date of randomization to the date of the participant's death.	Up to 15 years