This open-label, Phase 2 study is studying whether the monoclonal antibody Avelumab, in combination with radiation therapy, is safe in the treatment of relapsed/refractory myeloma.
- Open-Label: Patients and their doctors will know both the treatment and the dose that they will be receiving.
One of the ways that cancer cells have learned to protect themselves is by using special proteins that block our immune system from detecting and attacking them. Avelumab works by blocking the cancer’s protective protein (PD-L1), which helps our immune system to target and destroy any cancer cells it finds. Avelumab is currently FDA approved for use in Merkel-Cell Carcinoma (a type of skin cancer), but researchers are hopeful that it can be helpful in treating myeloma.
In this trial, Avelumab will be used concurrently with radiation therapy, so in order to be eligible, patients must have at least one plasmacytoma or lytic lesion that would be appropriate to treat with radiation therapy. This trial will be organized into 28 day cycles, and all patients who join this trial will receive the same regimen. Patients will receive Avelumab through an intravenous infusion every two weeks (on cycle days 1 and 15). After two doses of Avelumab (one cycle), patients will then receive five radiation therapy treatments on consecutive days. Patients may then continue to receive Avelumab every two weeks indefinitely, as long as they don’t develop bad side effects and their myeloma doesn’t get worse.
Patients will be monitored for overall response, development of side effects, and duration of response. Patients must have relapsed/refractory myeloma, and adequate bone marrow, liver, and kidney function to participate. Researchers are seeking 30 participants, and the study is scheduled to open in May 2019 at the National Institutes of Health in Bethesda, MD.
Click the link below to view full inclusion/exclusion criteria, and to learn more about this trial. You can also call SparkCures with any questions at (888) 828-2206.