What's the purpose of this trial?
This trial is testing a monoclonal antibody called SEA-BCMA. Researchers want to know what dose is safest, what side effects patients may have, and if SEA-BCMA will work to treat multiple myeloma.
SEA-BCMA is a type of treatment called a monoclonal antibody. Antibodies are part of your immune system. Usually, they help protect you from getting sick. With SEA-BCMA, researchers are using an antibody designed to stick to the multiple myeloma cells in your body. The antibody sends a signal to other cells in your immune system that kill the cancer cells. It also stops the multiple myeloma cells from getting a signal that makes them grow. The antibody may also stick to some non-cancer cells in your body.
They are asking you to be in this study because you have multiple myeloma that has come back or did not get better with your last therapy.
This trial is currently open and accepting patients.
What will happen during the trial?
This is a Phase 1b dose exploration and expansion study. The study is evaluating the safety, tolerability and efficacy of SEA-BCMA by itself, and when combined with Dexamethasone.
The dose expansion part of this study is being conducted in multiple parts, Part B (SEA-BCMA monotherapy), Part C (SEA-BCMA and Dexamethasone), and Part D (SEA-BCMA, Pomalidomide and Dexamethasone). This trial is open label, which means that both you and the researchers running the study will know what therapies you will receive.
Part B (SEA-BCMA Monotherapy)
This part of the study is evaluating the safety and tolerability of SEA-BCMA when given by itself. There are two phases in this part of the study, induction and maintenance therapy. This part of the study may enroll up to 40 patients.
- Induction Phase – This part of the study will last for two cycles, with each cycle lasting 28 days. Participants will receive SEA-BCMA every week during induction. At the end of the eight weeks, participants may move into the maintenance phase of the study if their myeloma has not progressed.
- Maintenance Phase – This part of the study is also set up in 28 day cycles. Participants will receive SEA-BCMA every two weeks.
Part C (SEA-BCMA and Dexamethasone)
This part of the study is evaluating the safety and tolerability of SEA-BCMA when combined with Dexamethasone. This part of the study is organized into two groups (cohorts) with different dosing schedules.
- Cohort 1 - This group is organized in 28 day cycles. Patients will receive SEA-BCMA (by intravenous infusion) every two weeks, and Dexamethasone (either a pill or intravenous infusion) weekly.
- Cohort 2 - This group is organized in 28 day cycles. Patients will receive SEA-BCMA (by intravenous infusion) every week for the first two cycles, and Dexamethasone (either a pill or intravenous infusion) weekly. If the participants myeloma has not worsened, they may then receive SEA-BCMA every two weeks, and Dexamethasone (either a pill or intravenous infusion) weekly.
Part D (SEA-BCMA, Pomalidomide and Dexamethasone)
This part of the study is organized into 28 day cycles. Patients will receive SEA-BCMA (by intravenous infusion) every two weeks, Pomalidomide (by mouth) every day on days 1-21, and Dexamethasone (either by mouth or intravenous infusion) weekly.
How Will The Study Treatment Be Administered?
If your study doctor decides you can be in the study, you can start treatment. SEA-BCMA will be given to you as a liquid into a vein, called an intravenous (IV) “infusion.” The treatment will be administered at the assigned dose every 2 weeks (or every 4 weeks if recommended).
We will treat you on 1 of these treatment schedules:
- Schedule 1: we will give you 1 infusion on the first day and 1 infusion on the 15th day of each 28 day treatment cycle (2 doses every 4 weeks)
- Schedule 2: we will give you an infusion on the first day of each 28 day treatment cycle (1 dose every 4 weeks)
During the study, Seattle Genetics will pay for:
- the study drug, SEA-BCMA
- any procedures done only for the study
You or your insurance company will be billed for your regular medical care. It's possible your insurance may not cover all of your regular medical care costs. You are responsible for the part your insurance doesn’t pay. If you’re not sure how this applies to you, ask your doctor or the study staff.
You won’t be paid for taking part in this study or for any discoveries made in this study.
You may be able to have some of your costs for taking part in the study paid back, like travel and lodging. Please call SparkCures at (888) 828-2206 or ask someone from the study staff for more information.
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.
- Are at least 18 years old
- Have relapsed or refractory myeloma.
- Have received at least 3 prior lines of therapy for your myeloma, including an immunomodulatory agent, proteasome inhibitor, and an anti-CD38 antibody and not have other therapies that could provide clinical benefit available
- Have not previously had a targeted BCMA therapy.
- Have not had an allogeneic stem cell transplant.
- No prior CAR T-cell therapy unless completed at least 8 weeks prior to first dose of SEA-BCMA
Additional Trial Information
Phase 1
Enrollment: 305 patients (estimated)
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