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.