Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The purpose of Phase 1b of the study is to determine the maximum tolerated dose (MTD) of oprozomib in combination with melphalan and prednisone (OMP).
The purpose of Phase 2 of the study is to estimate the overall response rate (ORR) and complete response rate (CRR) of the OMP combination.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Newly diagnosed symptomatic multiple myeloma patients who are transplant ineligible with measureable disease as indicated by one or more of the following:
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Creatinine clearance (CrCl) ≥ 30 mL/min, either measured or 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:
Primary purpose
Allocation
Interventional model
Masking
9 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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