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

Last Updated   April 24, 2024 - 21:00

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 4
    These 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
    43 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

Locations in:
United States, Spain, Netherlands, Japan, Israel, China, Belgium
Country (7) City or Province (43) Status
United States Atlanta, GA Emory University
RECRUITING
United States Boston, MA Beth Israel Deaconess Medical Center
RECRUITING
United States Boston, MA Dana Farber Cancer Institute
RECRUITING
United States Boston, MA Massachusetts General Hospital
RECRUITING
United States Bronx, NY Montefiore Medical Center
RECRUITING
United States Buffalo, NY Roswell Park Cancer Institute
RECRUITING
United States Charlotte, NC Levine Cancer Institute
RECRUITING
United States Chicago, IL Northwestern University
RECRUITING
United States Chicago, IL University of Chicago
RECRUITING
United States Detroit, MI Barbara Ann Karmanos Cancer Institute
RECRUITING
United States Duarte, CA City of Hope
RECRUITING
United States Hackensack, NJ Hackensack University Medical Center
RECRUITING
United States Houston, TX MD Anderson Cancer Center
RECRUITING
United States Indianapolis, IN Indiana University
RECRUITING
United States Milwaukee, WI Froedtert Memorial
RECRUITING
United States Nashville, TN Sarah Cannon Research Institute
RECRUITING
United States New Brunswick, NJ Rutgers Cancer Institute of New Jersey
RECRUITING
United States New York, NY Memorial Sloan Kettering Cancer Center
RECRUITING
United States New York, NY Mount Sinai Medical Center
RECRUITING
United States Philadelphia, PA University of Pennsylvania
RECRUITING
United States Phoenix, AZ Mayo Clinic Cancer Center-Scottsdale
RECRUITING
United States Pittsburgh, PA University of Pittsburgh Medical Center
RECRUITING
United States Rochester, MN Mayo Clinic Rochester
RECRUITING
United States Saint Louis, MO Washington University School of Medicine
RECRUITING
United States San Francisco, CA University of California San Francisco
RECRUITING
United States Westwood, KS Kansas University Medical Center
RECRUITING
Spain Pamplona Clinica Univ. de Navarra
RECRUITING
Spain Salamanca, SL Hosp. Clinico Univ. de Salamanca
RECRUITING
Netherlands Amsterdam VU Medisch Centrum
RECRUITING
Netherlands Groningen, GR University Medical Center Groningen
RECRUITING
Japan Nagoya Nagoya City University Hospital
ACTIVE_NOT_RECRUITING
Japan Shibuya, 13 Japanese Red Cross Medical Center
ACTIVE_NOT_RECRUITING
Israel Tel-Aviv Tel-Aviv Sourasky Medical Center
RECRUITING
China Beijing, 11 Peking University Third Hospital
RECRUITING
China Chengdu West China Hospital Si Chuan University
RECRUITING
China Fuzhou Fujian Medical University Union Hospital
RECRUITING
China Hangzhou First Hospital, Zhejiang University Medical College
RECRUITING
China Nanjing Jiangsu Province Hospital
RECRUITING
China Shanghai, 31 Ruijin Hospital, Shanghai Jiao Tong University
RECRUITING
China Shanghai, 31 Shanghai Fourth People s Hospital
RECRUITING
China Xi'an The Second Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Belgium Gent UZ Gent
RECRUITING
Belgium Leuven UZ Leuven
RECRUITING
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50

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10

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5

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Corresponds to individual site.

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