This randomized pilot phase I trial studies regulatory T-cell depletion before stem cell transplant in treating patients with multiple myeloma. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient’s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Regulatory T cells are a population of lymphocytes (white blood cells) that can prevent the immune system from fighting cancer cells. Removing the regulatory T cells from the donor cells before the transplant may reduce the risk that the disease will return.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01526096.
PRIMARY OBJECTIVES:
I. Determine the efficacy of ex vivo regulatory T cell depletion using anti-cluster of differentiation (CD)25-labeled microbeads in patients with multiple myeloma undergoing autologous stem cell transplant (ASCT).
II. Determine the efficacy of in vivo regulatory T cell depletion using an anti-CD25 monoclonal antibody in patients with multiple myeloma undergoing ASCT.
III. Determine potential toxicities of regulatory T cell depletion in patients with multiple myeloma undergoing ASCT.
IV. Compare the kinetics of regulatory T cell depletion and recovery following CD25-depletion using either the ex vivo or in vivo method.
V. To describe response and response duration after autologous transplant with regulatory T cell (Treg) depleted stem cell product.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM I (STANDARD ASCT): Patients receive melphalan intravenously (IV) over 15 minutes on days -3 and -2. Patients undergo ASCT on day 0.
ARM II (IN VIVO TREG DEPLETION [BASILIXIMAB] FOLLOWING ASCT): Patients receive melphalan IVPB and undergo ASCT as in Arm I. Patients also receive basiliximab IVPB over 20-30 minutes on day 1.
ARM III (EX VIVO TREG DEPLETION [ANTI-CD25 MICROBEADS] FROM PERIPHERAL BLOOD AUTOLOGOUS STEM CELL GRAFT PRIOR TO ASCT): Patients receive melphalan IVPB as in Arm I. Patients also receive anti-CD25-depleted autologous peripheral blood stem cells and undergo ASCT on day 0.
After completion of study treatment, patients are followed up weekly for 28 days and at 42, 60, 90, and 180 days.
Lead OrganizationUniversity of Chicago Comprehensive Cancer Center
Principal InvestigatorMichael R. Bishop
