A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Multiple Myeloma
Plasma cell neoplasm
18 Years and older, Male and Female
CR109123 (primary)
NCI-2022-01309
2020-005521-84
2023-505530-10-00
68284528MMY4002
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.
Objectives
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
- 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
Treatment Sites in Georgia
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