This is a phase 1/2a study designed to determine the safety and tolerability of TAK-079 monotherapy in women and men age 18 and older with relapsed or refractory multiple myeloma. TAK-079 is a fully human antibody that targets CD38+ leukocytes. TAK-079 treatment results in a rapid depletion of CD38. A number of hematologic tumors express CD38, including multiple myeloma (MM), acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma.
Subjects will receive TAK-079 via subcutaneous administration in each 28-day cycle of treatment, administered as once weekly for 8 weeks (8 doses), once every 2 weeks for 16 weeks (8 doses), and once every 4 weeks thereafter until disease progression.