This is a single arm, two-stage, phase II study to evaluate the rate of ≥ Complete Response (CR) post-Autologous Stem Cell Transplant (ASCT) in Multiple Myeloma (MM) subjects who failed to achieve at least a Very Good Partial Response (VGPR) post initial induction therapy for newly diagnosed disease, and for whom an ASCT is planned. Subjects will be treated with four weekly doses of daratumumab before mobilization for Hematopoietic Progenitor Cells (HPC) collection, followed by high dose chemotherapy and ASCT and four weekly doses of daratumumab after ASCT. A two-stage design will be implemented. Twenty three (23) subjects will be enrolled in the first stage, and if at least 12 of the 23 subjects have at least a CR after ASCT, an additional 16 subjects will be enrolled in the second stage (a total of 39 subjects).
This study will use the drug daratumumab in patients who did not achieve at least a very good partial response (VGPR) and are already planned to have an Autologous Stem Cell Transplant (ASCT). Daratumumab will be given before the stem cell collection to attempt to get rid of any multiple myeloma cells that may be present in the stem cell collection and after the ASCT to get rid of any multiple myeloma cells that may be remaining.