Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

Inclusion Criteria

INCLUSION CRITERIA:

- Diagnosis of multiple myeloma with measureable disease

- Patients requiring therapy who have relapsed and/or are refractory to their last
therapy and have been treated with at least 1, but not more than 5 lines of multiple
myeloma therapy.

EXCLUSION CRITERIA:

- Radiation therapy within 2 weeks prior to first dose. Localized radiation therapy
within 1 week prior to first dose.

- Immunotherapy/standard myeloma therapy within 2 weeks; prior stem cell transplant
(SCT) therapy (autologous SCT within the prior 8 weeks; allogeneic SCT within the
prior 16 weeks)

- Participation in an investigational therapeutic study within 3 weeks prior to first
dose

- Patients who failed to respond to carfilzomib treatment defined as not having
achieved ≥ PR during therapy

- Carfilzomib exposure within 6 months prior to first dose

- Prior oprozomib exposure

- Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the
first dose

- Other malignancy within the past 3 years with the exception of adequately treated
basal cell carcinoma of the skin, squamous cell skin cancer, thyroid cancer,
carcinoma in situ of the cervix, carcinoma in situ of the breast, prostate cancer of
Gleason Score 6 or less with stable prostate specific antigen levels, or cancer
considered cured by surgical resection.

- Plasma cell leukemia