A phase 1 study of SEA-BCMA in patients with relapsed or refractory multiple myeloma

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Overview

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:

  • 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)

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.

SparkCures ID 961
Trial Phase Phase 1
Enrollment 65 Patients
Treatments
Trial Sponsors
  • Seattle Genetics
NCT Identifier

NCT03582033

Am I Eligible?

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.

  • Are at least 18 years old
  • Have relapsed or refractory multiple myeloma
  • Must have received at least three prior lines of therapy including at least a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody and not have other therapies that could provide clinical benefit available
  • No prior exposure to any other BCMA-directed therapy
  • Patients cannot have received a previous allogeneic stem cell transplant (SCT)
  • No prior CAR T-cell therapy unless completed at least 8 weeks prior to first dose of SEA-BCMA.

The following criteria is provided for health care professionals.

  • Inclusion Criteria:

    • Histologically confirmed diagnosis of multiple myeloma (MM)
    • Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1
    • Must have MM that is relapsed or refractory and must not have other therapeutic options available known to provide clinical benefit in MM
    • Has received a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody
    • Life expectancy of greater than 3 months in the opinion of the investigator
    • Patients of childbearing potential or who can father children must agree to consistently use 2 effective forms of birth control for at least 6 months after the final dose of study drug administration
    • Adequate hematologic, renal, and hepatic function
    • Measurable disease, as defined by at least one of the following: (1) serum M protein 0.5 g/dL or higher, (2) urine M protein 200 mg/24 hour or higher, and (3) serum immunoglobulin free light chain 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda free light chain ratio.

    Exclusion Criteria:

    • Prior treatment with a BCMA targeted therapeutic
    • Patients who are pregnant or breastfeeding
    • History of another malignancy within 3 years
    • Active cerebral or meningeal disease related to the underlying malignancy
    • Uncontrolled Grade 3 or higher infection
    • Prior antitumor therapy that is not completed at least 4 weeks prior to first dose of study drug, or at least 2 weeks if progressing. Prior CAR T-cell therapy must be completed 8 weeks before first dose of study drug.

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Weill Cornell Medicine<br />
Weill Cornell Medicine

New York, NY

Florida
Kansas
University of Kansas Cancer Center
Missouri
Siteman Cancer Center<br />Washington University Medical Campus
New York
Weill Cornell Medicine<br />
Weill Cornell Medicine

New York, NY

Washington
Fred Hutchinson Cancer Research Center

Resources

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