Multiple Myeloma Clinical Trial
A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
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.
Full 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
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There are 42 Locations for this study
Phoenix Arizona, 85054, United States
Duarte California, 91010, United States
San Francisco California, 94143, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46202, United States
Westwood Kansas, 66205, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Rochester Minnesota, 55902, United States
Saint Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
New Brunswick New Jersey, 08903, United States
Bronx New York, 10467, United States
Buffalo New York, 14263, United States
New York New York, 10029, United States
New York New York, 10065, United States
Charlotte North Carolina, 28204, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Milwaukee Wisconsin, 53226, United States
Gent , 9000, Belgium
Leuven , 3000, Belgium
Beijing , 10019, China
Chengdu , 61004, China
Fuzhou , 35000, China
Hangzhou , 31000, China
Nanjing , 21002, China
Shanghai , 20002, China
Shanghai , 20043, China
Xi'an , 71000, China
Tel-Aviv , 64239, Israel
Nagoya , 467 8, Japan
Shibuya , 150-8, Japan
Amsterdam , 1081 , Netherlands
Groningen , 9713 , Netherlands
Pamplona , 31008, Spain
Salamanca , 37007, Spain
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