A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Last Updated   April 24, 2024 - 21:00
OVERVIEW
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Gender
all -
Age
years -
Phase
phase 4These studies are conducted after a drug or treatment is approved for use by regulatory authorities. Phase 4 studies gather additional information on the drug's effects and side effects. -
Sites
sites -
Status
Recruiting
SUMMARY
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.
CONDITIONS
- Multiple Myeloma
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
DETAILS
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.
LOCATIONS
Country (7) | City or Province (43) | Status |
United States | Atlanta, GA Emory University |
RECRUITING
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United States | Boston, MA Beth Israel Deaconess Medical Center |
RECRUITING
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United States | Boston, MA Dana Farber Cancer Institute |
RECRUITING
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United States | Boston, MA Massachusetts General Hospital |
RECRUITING
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United States | Bronx, NY Montefiore Medical Center |
RECRUITING
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United States | Buffalo, NY Roswell Park Cancer Institute |
RECRUITING
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United States | Charlotte, NC Levine Cancer Institute |
RECRUITING
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United States | Chicago, IL Northwestern University |
RECRUITING
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United States | Chicago, IL University of Chicago |
RECRUITING
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United States | Detroit, MI Barbara Ann Karmanos Cancer Institute |
RECRUITING
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United States | Duarte, CA City of Hope |
RECRUITING
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United States | Hackensack, NJ Hackensack University Medical Center |
RECRUITING
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United States | Houston, TX MD Anderson Cancer Center |
RECRUITING
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United States | Indianapolis, IN Indiana University |
RECRUITING
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United States | Milwaukee, WI Froedtert Memorial |
RECRUITING
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United States | Nashville, TN Sarah Cannon Research Institute |
RECRUITING
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United States | New Brunswick, NJ Rutgers Cancer Institute of New Jersey |
RECRUITING
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United States | New York, NY Memorial Sloan Kettering Cancer Center |
RECRUITING
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United States | New York, NY Mount Sinai Medical Center |
RECRUITING
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United States | Philadelphia, PA University of Pennsylvania |
RECRUITING
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United States | Phoenix, AZ Mayo Clinic Cancer Center-Scottsdale |
RECRUITING
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United States | Pittsburgh, PA University of Pittsburgh Medical Center |
RECRUITING
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United States | Rochester, MN Mayo Clinic Rochester |
RECRUITING
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United States | Saint Louis, MO Washington University School of Medicine |
RECRUITING
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United States | San Francisco, CA University of California San Francisco |
RECRUITING
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United States | Westwood, KS Kansas University Medical Center |
RECRUITING
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Spain | Pamplona Clinica Univ. de Navarra |
RECRUITING
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Spain | Salamanca, SL Hosp. Clinico Univ. de Salamanca |
RECRUITING
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Netherlands | Amsterdam VU Medisch Centrum |
RECRUITING
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Netherlands | Groningen, GR University Medical Center Groningen |
RECRUITING
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Japan | Nagoya Nagoya City University Hospital |
ACTIVE_NOT_RECRUITING
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Japan | Shibuya, 13 Japanese Red Cross Medical Center |
ACTIVE_NOT_RECRUITING
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Israel | Tel-Aviv Tel-Aviv Sourasky Medical Center |
RECRUITING
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China | Beijing, 11 Peking University Third Hospital |
RECRUITING
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China | Chengdu West China Hospital Si Chuan University |
RECRUITING
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China | Fuzhou Fujian Medical University Union Hospital |
RECRUITING
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China | Hangzhou First Hospital, Zhejiang University Medical College |
RECRUITING
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China | Nanjing Jiangsu Province Hospital |
RECRUITING
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China | Shanghai, 31 Ruijin Hospital, Shanghai Jiao Tong University |
RECRUITING
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China | Shanghai, 31 Shanghai Fourth People s Hospital |
RECRUITING
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China | Xi'an The Second Affiliated Hospital of Xi'an Jiaotong University |
RECRUITING
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Belgium | Gent UZ Gent |
RECRUITING
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Belgium | Leuven UZ Leuven |
RECRUITING
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