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Complete title: Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Combination with Lenalidomide or Oral Cyclophosphamide in Patients with Newly Diagnosed Multiple Myeloma
|Research Study Number||2723.00|
|Principal Investigator||Bill Bensinger, MD|
Research Study Description
-- To establish the maximum tolerated dose (MTD) of oprozomib administered orally in combination with lenalidomide and dexamethasone
- Phase 2:
-- To estimate the overall response rate (ORR) and complete response rate (CRR)
- Secondary Objectives:
-- * To evaluate the safety and tolerability of oprozomib administered in combination with lenalidomide and dexamethasone
-- * To evaluate population pharmacokinetic (PK) parameter estimates of oprozomib and variability in these estimates when administered in combination with lenalidomide and dexamethasone
-- * To estimate the duration of response (DOR)
-- * To estimate progression-free survival (PFS)
Eligibility Criteria (must meet the following to participate in this study)
Other eligibility criteria may apply.
Hematologic Malignancies; Lymphoproliferative Disorders; Multiple Myeloma (MM)
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