Study of Oprozomib and Dexamethasone, in Combination With Lenalidomide or Oral Cyclophosphamide in Patients With Newly Diagnosed Multiple Myeloma

Key Inclusion Criteria:

- Newly diagnosed, symptomatic multiple myeloma patients for whom treatment is indicated
per the NCCN guidelines, and for whom a hematopoietic stem cell transplant is not
planned or scheduled during the study or are considered ineligible for hematopoietic
stem cell transplant, with measurable disease

- Creatinine clearance of ≥ 50 mL/min (measured or calculated using the Cockcroft and
Gault formula)

Key Exclusion Criteria:

- Any prior systemic antimyeloma therapy except oral steroids (dexamethasone up to a
total dose of 160 mg or equivalent within 14 days prior to the first dose of study
treatment). Use of topical or inhaled steroids is acceptable

- Radiation therapy within 2 weeks prior to first dose

- Major surgery within 3 weeks prior to first dose

- Active infection requiring systemic antibiotics, antivirals, or antifungals within 2
weeks prior to first dose

- Clinical significant gastrointestinal bleeding in the 6 months prior to Cycle 1 Day 1
(C1D1) first dose

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

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