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, we 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's being studied?

• SEA-BCMA is a monoclonal antibody that targets the B-Cell Maturation Antigen (BCMA) and is made with Sugar Engineered Antibody (SEA) technology. Researchers believe this approach may improve immune response to cancer cells.

What will happen during the trial?

This study has been planned in two parts, dose escalation and dose expansion.

• Dose Escalation - This means a small group of patients will receive a dose of SEA-BCMA. If that dose is determined to be safe, a second group will receive a higher dose of SEA-BCMA. This will continue until researchers find the highest dose of SEA-BCMA that is tolerated without bad side effects.
• Dose Expansion - Patients in this phase will receive the dose found to work best with the least side effects from phase 1. This dose is called the maximum tolerated dose (MTD).
• Both Part 1 and 2 of this study will follow the same schedule.

This trial is open label, which means that both you and the researchers running the study will know what dose of SEA-BCMA you will receive.

SEA-BCMA will be given as an IV infusion on day 1 and day 15 of each 28 day treatment cycle. You can continue to receive SEA-BCMA as long as your myeloma doesn’t get worse, and you don’t develop bad side effects.

Other treatment schedules may be available as the study progresses.

After you have stopped receiving SEA-BCMA, study investigators will ask you to participate in a follow up visit or phone call every 3 months until the study ends.

You can decide to stop being in the study at any time. You can still go to your regular hospital or clinic for treatment after you leave this study.

If you decide to stop treatment with SEA-BCMA, you will still be asked to come back to the hospital or clinic for follow-up tests. You may also be asked to take part in follow-up phone calls and visits.

Financial Assistance

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 ask someone from the study staff for more information.

Additional Trial Information

Phase 1

Enrollment: 185 patients (estimated)