A Phase I/II Study of BI-505 in Conjunction With Autologous Stem Cell Transplant in Multiple Myeloma

Inclusion Criteria: * A diagnosis of multiple myeloma by 2014 IMWG criteria and have been recommended to undergo HDM + ASCT as a standard-of-care therapy for their multiple myeloma. * Subjects must have adequate vital organ function and functional status for HDM + ASCT * Subjects must have collected and cryopreserved ≥4x106 hematopoietic stem cells per kg of actual body weight that are suitable for use in autologous stem cell transplantation in the judgment of the investigator. * At the time of enrollment, subjects must have had at least a partial response, as defined by IMWG criteria and in comparison to baseline/pre-treatment parameters, to an induction regimen containing lenalidomide and/or bortezomib. * Subjects must have measurable disease according to one of the following criteria: 1. Serum M-spike ≥0.1 g/dl 2. Urine M-spike \>200 mg in a 24-hour urine collection 3. Involved serum free light chain above the upper limit of normal and a serum free light chain ratio outside the normal range. * At the time of enrollment, subjects must be within 12 months of the first dose of initial/induction therapy, and the anticipated day of ASCT must be within 12 months of the first dose of initial/induction therapy Exclusion Criteria: * Prior allogeneic or autologous hematopoietic stem cell transplant * Current active infections, including HIV and hepatitis C and B * Autoimmune disease requiring ongoing immunosuppressive therapy. * History of atrial fibrillation or flutter, including paroxysmal atrial fibrillation or flutter. * History of transient ischemic attack or stroke. * At the time of enrollment, subjects must not have required multi-agent continuous-infusion cytotoxic chemotherapy (e.g., regimens such as D-PACE) as part of their initial/induction therapy.