Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT05767359
Brief Summary:
The goal of this research study is to test if ciltacabtagene autoleucel (cilta-cel) is safe and effective in treating participants with high-risk, smoldering myeloma.
The names of the treatment interventions used in this study are:
* Cilta-cel (or chimeric antigen receptor T cells)
* Cyclophosphamide (a lymphodepleting chemotherapy)
* Fludarabine (a lymphodepleting chemotherapy)
Detailed Description:
This is a Phase II study to test the safety and effectiveness of study therapy cilta-cel in treating participants with high-risk smoldering multiple myeloma (SMM). T cells are a part of a person's immune system which usually helps fight infection and prevents/fights cancer cells.
The U.S. Food and Drug Administration (FDA) has approved cilta-cel as a treatment for relapsed and refractory multiple myeloma but not specifically for smoldering myeloma.
The research study procedures include screening for eligibility, study treatment including evaluations, blood collections, radiologic scans of tumors, bone marrow biopsies, and follow-up visits.
Participation in this study is expected to last about 15 years.
It is expected that about 20 people will take part in this research study.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational therapy to learn whether the therapy works in treating a specific disease. "Investigational" means that the therapy is being studied.
Janssen Research \& Development, LLC is supporting this research study by providing the study treatment and funding.
Study:
NCT05767359
Study Brief:
Protocol Section:
NCT05767359