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:

Serum M-spike ≥0.1 g/dl
Urine M-spike >200 mg in a 24-hour urine collection
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.