CARTITUDE-2
Phase 2, Open-Label Study Evaluating the Use of an Investigational CAR-T Cell therapy in Participants with Multiple Myeloma
What will happen during the trial?
This clinical trial is seeking participants who will be divided into multiple different groups (or cohorts). Cohorts are groups of participants who meet specific criteria with multiple myeloma. Your diagnosis, past treatment history, and responses to past treatments will determine which cohort you may be eligible for. All cohorts in this trial will receive the investigational medication, with some cohorts receiving other approved therapies as well.
This trial is currently only enrolling cohort G. All patients enrolled in cohorts G will receive induction therapy followed by treatment with an investigational CAR-T medication. Patients enrolled in Cohort G will receive four cycles of induction therapy with Daratumumab, Lenalidomide and dexamethasone.
Treatment Involved
The investigational medication is an autologous chimeric antigen receptor T cell (CAR-T) therapy. This means it is made using your own T cells and is being evaluated to determine if it will then kill cancerous myeloma cells. In this study, some of your T cells will be removed from your blood by a process called apheresis. These T cells will then be modified in a laboratory. These T cells will then be given back to you by an intravenous infusion. The process to modify your T cells to become CAR-T cells will be explained further by a study staff member.
Before you receive the investigational medication, you will receive a conditioning regimen of chemotherapies, cyclophosphamide and fludarabine, by intravenous infusion once daily over a period of three days.
Depending on different factors, you may be hospitalized while you receive the investigational medication and will be hospitalized for a period afterwards.
Participants will have follow-up visits with the study team. Additionally, after the trial, participants who receive the investigational CAR-T cell medication will be followed yearly for 15 years.
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.
More Information
- Trial Status
- Accepting patients
- Trial Phase
- Phase 2
- Enrollment
- 237 patients (estimated)
- Sponsors
- Janssen Research & Development LLC
- Tags
- CAR T Cell, B-Cell Maturation Antigen (BCMA)
- Trial Type
- Treatment
- Last Update
- 4 days ago
- SparkCures ID
- 1039
- NCT Identifier
- NCT04133636
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