What's the purpose of this trial?
The goal of this clinical trial is compare the safety and efficacy of a study medication by itself versus two other combinations, Pomalidomide, Bortezomib and Dexamethasone or Carfilzomib and Dexamethasone in participants who have relapsed or refractory multiple myeloma.
This trial is currently open and accepting patients.
What will happen during the trial?
This clinical trial is seeking approximately 590 patients, who will be randomly assigned into one of two different groups. You will have a 50% chance of being in either group. This study is open-label, which means that both the participants and the study team will know which group they have been placed in and which therapies they will receive. Participants may continue to participate in the study as long as their myeloma doesn’t get worse and they don’t experience bad side effects.
Group A will receive the study medication by itself. Participants in Group B will receive either Pomalidomide, Bortezomib and Dexamethasone OR Carfilzomib and Dexamethasone. The study physician will decide which combination you receive, depending on your treatment history and other factors.
The study medication used in Group A is a bispecific antibody that targets two different proteins. The two proteins are CD3 on your own T-cells, and BCMA, which is found on myeloma cells. This medication may work by bringing together your T-cells and myeloma cells in order to help your own immune system fight your myeloma.
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.
You may be able to join this trial if you:
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.
- have measurable disease as defined by the trial protocol.
- have received 1-3 prior lines of therapy, including at least two cycles of an anti-CD38 monoclonal antibody and Lenalidomide.
- have not previously received anti-BCMA targeted therapy.
- have not previously received both Pomalidomide and Carfilzomib. Participants who have received only one of either Pomalidomide or Carfilzomib are still eligible to join this study.
- have not had an autologous stem cell transplant in the last three months and have not had an allogeneic stem cell transplant in the last six months.
- do not have central nervous system involvement of your myeloma.
Additional Trial Information
Phase 3
Enrollment: 650 patients (estimated)
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