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

Active:	Yes
Cancer Type:	Multiple Myeloma Plasma cell neoplasm	NCT ID:	NCT05201781
Trial Phases:	Phase IV	Protocol IDs:	CR109123 (primary) NCI-2022-01309 2020-005521-84 2023-505530-10-00 68284528MMY4002
Eligibility:	18 Years and older, Male and Female	Study Type:	Other
Study Sponsor:	Janssen Research & Development, LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT05201781

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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