We are doing this study to learn about any side effects patients have when they are treated with SEA-BCMA. We also want to find out if SEA-BCMA works to treat multiple myeloma. We want to see if patients with multiple myeloma respond to the drug. If patients respond, we want to see how long the response lasts.
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.
If you choose to take part in this clinical trial, we will do tests to see if you can be in the study. If you can be in the study and choose to take part, we will do tests to see if SEA-BCMA is safe and if it can affect your disease. If your cancer stays the same or gets better, and you don’t have any serious problems, you can keep getting SEA-BCMA until your multiple myeloma gets worse or you have bad side effects.
We will take blood samples for safety and research tests and to check on your disease. These are extra blood samples just for the study. You will also get blood drawn for your normal medical care. A visiting nurse service may come to your home to take some of these blood samples.
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:
How long will I be in the study?
We will give you SEA-BCMA once every 14 days or once every 28 days in 28-day cycles. If your cancer stays the same or gets better, and you don’t have bad side effects, you can keep getting treated with SEA-BCMA in the study. After you have stopped getting SEA-BCMA, we will ask you to have follow-up visits or phone calls about every 12 weeks or until the study is closed.
If your cancer gets better when you are getting treatment in the study and then gets worse after you stop getting SEA-BCMA, your doctor might say you can get SEA-BCMA again. If this happens, we will do tests to see if you can be treated in the study again.
The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.
The following criteria is provided for health care professionals.
The following is a listing of trial locations that are open and accepting patients.
The following is a listing of trial locations that are not currently open and accepting patients.
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