This trial is comparing the safety and efficacy of VRd followed by an investigational CAR-T cell therapy versus VRd and Rd in participants with newly diagnosed multiple myeloma.
This trial is currently open and accepting patients.
This trial is seeking approximately 650 participants, who will be randomly assigned into one of two different groups (or cohorts). Cohorts are groups of participants who meet specific criteria for Multiple Myeloma. Before being separated into different arms (randomization), all participants in the study will receive 5-6 cycles of Bortezomib, Lenalidomide, and Dexamethasone (VRd). Participants will need to visit the study site four times during each 21 day cycle.
During these initial cycles before being placed into different groups, participants will receive:
The investigational medication is an investigational autologous chimeric antigen receptor T cell (CAR-T) therapy. This means it’s a therapy made from your own T cells, to try and kill your cancerous multiple myeloma cells. In this study, your doctor will draw whole blood and separate it into its parts- plasma and white blood cells (T-cells). This process is called apheresis. These T cells will then be changed in a laboratory by giving them some new genetic material. These T cells will then be given back to you by an intravenous infusion.
You will not be paid for taking part in this study. You may receive reimbursement or stipend(s) to help with your expenses (e.g., mileage, parking, and/or meals) for attending study visits. If a caregiver is needed to accompany you to your study visits, your caregiver may receive reimbursement or stipend(s) to offset expenses (e.g. meals) for attending study visits with you. If applicable, travel assistance (e.g. car service, train, hotel arrangements) may be offered in lieu of reimbursement, to help you get to and from your study visits and to provide accommodations as necessary during your participation in the study. The study site will discuss the options that are available for you. Janssen is committed to Health Equity. Once assigned to a study site, please inquire about financial programs in place to support clinical trial participation.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
Enrollment: 650 patients (estimated)View More
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San Francisco, CA
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