A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cilta-cel.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, China, France, Israel +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Overview
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.
Interventions
- Drug Cilta-cel
Participants who had received cilta-cel in previous studies will be followed up in this study. No additional study treatment will be administered to participants in this study.
Primary outcome measures
- Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy [Time frame: Up to 15 years]
- Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder [Time frame: Up to 15 years]
- Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder [Time frame: Up to 15 years]
- Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia [Time frame: From year 1 up to year 5]
- Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia [Time frame: From year 6 up to year 15]
- Number of Participants with New Incidence of Grade >= 3 Infection [Time frame: From year 1 up to year 5]
- Number of Participants with Serious Infection [Time frame: From year 6 up to year 15]
- Number of Participants with Serious Adverse Events (SAEs) [Time frame: From year 1 up to year 5]
- Number of Participants with Related Serious Adverse Events Assessed by the Investigator [Time frame: From year 6 up to year 15]
Secondary outcome measures (5)
- Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood [Time frame: Up to 15 years]
- Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells [Time frame: Up to 15 years]
- Pattern of Lentiviral Vector Integration Sites [Time frame: Up to 15 years]
- Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments [Time frame: Up to 15 years]
- Overall Survival (OS) [Time frame: Up to 15 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 28 centers
- Mayo Clinic Cancer Center-Scottsdale — Phoenix
- City of Hope — Duarte
- University of California San Francisco — San Francisco
- Stanford University Medical Center — Stanford
- Moffitt Cancer Center — Tampa
- Emory University — Atlanta
- Northwestern University — Chicago
- University of Chicago — Chicago
- … and 20 more centers
China · 11 centers
- Peking University Third Hospital — Beijing
- West China Hospital Si Chuan University — Chengdu
- Fujian Medical University Union Hospital — Fuzhou
- Sun Yat-sen University Cancer Hospital — Guangzhou
- First Hospital, Zhejiang University Medical College — Hangzhou
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School — Nanjing
- Jiangsu Province Hospital — Nanjing
- Shanghai Changzheng Hospital — Shanghai
- … and 3 more centers
Belgium · 2 centers
- UZ Gent — Ghent
- UZ Leuven — Leuven
France · 2 centers
- CHRU de Lille Hopital Claude Huriez — Nord
- Hopital Saint Louis — Paris
Japan · 2 centers
- Nagoya City University Hospital — Nagoya
- Japanese Red Cross Medical Center — Shibuya City
Netherlands · 2 centers
- VU Medisch Centrum — Amsterdam
- University Medical Center Groningen — Groningen
Spain · 2 centers
- Clinica Univ. de Navarra — Pamplona
- Hosp Clinico Univ de Salamanca — Salamanca
Israel · 1 center
- Tel Aviv Sourasky Medical Center — Tel Aviv
Identifiers
NCT: NCT05201781 · CR109123 · 68284528MMY4002 · 2020-005521-84 · 2023-505530-10-00