HCC 18-037 – Relapsed or Refractory Multiple Myeloma

STUDY BASICS

Have you been diagnosed with multiple myeloma that has come back after treatment (relapsed) or that did not respond to treatment (refractory)? If so, you may be eligible to participate in a research study to help find the safest and most effective dose of an investigational drug called BION-1301. Eligible participants will receive BION-1301 every two weeks as an intravenous (IV) drug.

STUDY PURPOSE

Multiple myeloma is a type of cancer in which abnormal white blood cells build up in the bone marrow and form tumors in the bones. While many treatments exist for multiple myeloma, the cancer often returns after treatment (called relapsed multiple myeloma) or does not respond to treatment (called refractory multiple myeloma). The purpose of this study is to find the safest and most effective dose of an investigational new drug called BION-1301. BION-1301 is a monoclonal antibody designed to block proteins that help multiple myeloma cells survive. Researchers hope their findings will lead to a new way to treat people with relapsed or refractory multiple myeloma.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18 and up
• Diagnosed with multiple myeloma that has returned after treatment (called relapsed multiple myeloma) or that did not respond to treatment (called refractory multiple myeloma)

WHAT PARTICIPANTS CAN EXPECT

This study involves an initial screening visit to find out if you are eligible to take part in the study. If eligible after screening, you will receive BION-1301 every two weeks by intravenous (IV) infusion. Each dose will take about 2 hours. During the study, participants will have frequent tests and assessments including blood draws, urine collection, HIV testing, x-ray imaging, electrocardiogram, and a bone marrow biopsy or aspirate (a small sample of fluid collected by needle). After the final dose of the study drug, you will be asked to return for an end of treatment visit within 28 days after your last dose of study drug. After that, you will be contacted every 12 weeks by telephone.