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

Key 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.

- Prior carfizolmib is not required but is allowed if a patient had at least 2 cycles of
carfilzomib alone or in combination with a dose of at least 20/27 mg/m2, as long as
the patient :

1. Had at least a partial response to prior carfilzomib therapy

2. Was not removed from carfilzomib therapy due to toxicity, unless approved by the
medical monitor

3. Was not removed from carfilzomib therapy for progressive disease nor experienced
progressive disease within 6 months after any prior carfizolmib therapy

- Calculated or measured creatinine clearance (CrCl) rate of ≥ 30 mL/min calculated
using the formula of Cockcroft and Gault [(140 − age) × mass (kg) / (72 × serum
creatinine mg/dL)]. Multiply result by 0.85 if female.

Key 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

- 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

- History of previous clinically significant GI bleed in the last 6 months prior to
first dose