Phase 1b/2, Multicenter, Open-label Study of Oprozomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
- Newly diagnosed, symptomatic multiple myeloma patients 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
- Any prior 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.
- Major surgery within 3 weeks prior to first dose
- Active infection requiring systemic antibiotics, antivirals, or antifungals within 2
weeks prior to first dose
- Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of first
- 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
with Gleason Score 6 or less with stable prostate specific antigen levels, or cancer
considered cured by surgical resection