Clinical trial NCT05201781: A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Official title: Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Multiple Myeloma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-01-21
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy
timeFrame: Up to 15 years
measure: Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder
timeFrame: Up to 15 years
measure: Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder
timeFrame: Up to 15 years
measure: Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia
timeFrame: From year 1 up to year 5
measure: Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia
timeFrame: From year 6 up to year 15
measure: Number of Participants with New Incidence of Grade >= 3 Infection
timeFrame: From year 1 up to year 5
measure: Number of Participants with Serious Infection
timeFrame: From year 6 up to year 15
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: From year 1 up to year 5
measure: Number of Participants with Related Serious Adverse Events Assessed by the Investigator
timeFrame: From year 6 up to year 15
Secondary outcomes:
measure: Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood
timeFrame: Up to 15 years
measure: Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells
timeFrame: Up to 15 years
measure: Pattern of Lentiviral Vector Integration Sites
timeFrame: Up to 15 years
measure: Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments
timeFrame: Up to 15 years
measure: Overall Survival (OS)
timeFrame: Up to 15 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Cancer Center-Scottsdale
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Westwood
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Milwaukee
country: United States
facility: Froedtert Memorial
state: Wisconsin
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Beijing
country: China
facility: Peking University Third Hospital
city: Chengdu
country: China
facility: West China Hospital Si Chuan University
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Hangzhou
country: China
facility: First Hospital, Zhejiang University Medical College
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University
city: Shanghai
country: China
facility: Shanghai Fourth People s Hospital
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
city: Nord
country: France
facility: CHRU de Lille Hopital Claude Huriez
city: Paris
country: France
facility: Hopital Saint Louis
city: Tel-Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Shibuya
country: Japan
facility: Japanese Red Cross Medical Center
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
city: Salamanca
country: Spain
facility: Hosp Clinico Univ de Salamanca
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: