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.

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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.

View Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 4

Estimated Enrollment:

228

Study ID:

NCT05201781

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 32 Locations for this study

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Mayo Clinic Cancer Center-Scottsdale
Phoenix Arizona, 85054, United States
City of Hope
Duarte California, 91010, United States
University of California, San Francisco
San Francisco California, 94143, United States
University of Chicago
Chicago Illinois, 60637, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Massachusetts General Hospital
Boston Massachusetts, 02215, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Mayo Clinic Rochester
Rochester Minnesota, 55902, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Froedtert Memorial
Milwaukee Wisconsin, 53226, United States
UZ Gent
Gent , 9000, Belgium
UZ Leuven
Leuven , 3000, Belgium
Peking University Third Hospital
Beijing , 10019, China
West China Hospital, Si Chuan University
Chengdu , 61004, China
Fujian Medical University Union Hospital
Fuzhou , 35000, China
First Hospital, Zhejiang University Medical College
Hangzhou , 31000, China
Jiangsu Province Hospital
Nanjing , 21002, China
Shanghai Changzheng Hospital
Shanghai , 20000, China
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai , 20002, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an , 71000, China
Sheba Medical Center
Ramat Gan , 57261, Israel
Tel-Aviv Sourasky Medical Center
Tel-Aviv , 64239, Israel
Nagoya City University Hospital
Nagoya , 467-8, Japan
Japanese Red Cross Medical Center
Shibuya , 150-8, Japan
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 4

Estimated Enrollment:

228

Study ID:

NCT05201781

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

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