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.
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)