Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma

A multicenter, non-randomized, open-label, dose-exploration study evaluating two new
formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed
refractory multiple myeloma. The study will be conducted in two parts. Part 1 will evaluate
the formulations of oprozomib in combination with dexamethasone only. Part 2 will evaluate
the formulations of oprozomib administered at increasing dose levels (dose escalation) in
combination with pomalidomide and dexamethasone.

Inclusion criteria

- Subject must have a pathologically documented, definitively diagnosed, multiple
myeloma relapsed, or refractory progressive disease after at least 2 lines of therapy
for multiple myeloma. Prior therapeutic treatment or regimens must include a
proteasome inhibitor and lenalidomide.

- Subject must be willing and able to undergo bone marrow aspirate per protocol (with or
without bone marrow biopsy per institutional guidelines).

- Measurable disease (assessed within 28 days prior to day 1)

- Eastern Cooperative Oncology Group (ECOG) performance status of <= 2.

- Other Inclusion Criteria May Apply

Exclusion Criteria

- Currently receiving treatment in another investigational device or drug study, or less
than 28 days or 5 half-lives whichever is shorter since ending treatment on another
investigational device or drug study(s).

- Previously received an allogeneic stem cell transplant and the occurrence of one or
more of the following: received the transplant within 6 months prior to study day
1;received immunosuppressive therapy within the last 3 months prior to study day
1;having signs or symptoms of acute or chronic graft-versus-host disease.

- Autologous stem cell transplant < 90 days prior to study day 1.

- Multiple myeloma with IgM subtype.

- POEMs syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and
skin changes).

- Plasma cell leukemia (> 2.0 X109/L circulating plasma cells by standard differential).

- Waldenstrom's macroglobulinemia.

- Other Exclusion Criteria May Apply