Clinical Trial of Consolidation Treatment With Iodine I 131 Tositumomab for Multiple Myeloma
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This study is for patients with newly diagnosed or relapsed multiple myeloma. The main
purpose of this study is to see how their disease responds to consolidation treatment
(treatment aimed at further decreasing cancer cells) with a radioactive antibody (protein)
called iodine I 131 tositumomab (known by the tradename Bexxar®) and also to look at the side
effects which occur with this type of treatment. The investigators will also be looking at
how long disease responds to treatment, if it responds at all, and how long patients who have
had this treatment survive.
Bexxar is a monoclonal antibody (protein) to which radioactive iodine 131 is attached. The
monoclonal antibody in Bexxar (tositumomab), targets a protein called CD20 found on the
surface of a variety of B-cells, including lymphoma cells, and some myeloma cells. The
antibody is given as an infusion and finds its way to these cells. The radioactive iodine
attached to the antibody delivers radiation directly to these cells which works to harm or
kill the cancer cells. Approximately 20-25% of patients with multiple myeloma have this
protein on the surface of their tumor cells. In addition, this protein was found on the
surface of myeloma stem cells. While myeloma stem cells represent a minority of all myeloma
cells (less than 5%), these cells are resistant to chemotherapy and are believed to be
responsible for a recurrence of the disease after chemotherapy. In this study, Bexxar will be
used after patients complete a course of chemotherapy and have residual myeloma cells left in
their body. The Investigators are hoping that the treatment with Bexxar will decrease and
possibly eliminate residual myeloma cells resistant to chemotherapy.
Phase:
Phase 2
Details
Lead Sponsor:
University of Michigan Cancer Center University of Michigan Rogel Cancer Center