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Phase 1b/2, Multicenter, Open-label Study of Oprozomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

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
    
Phase       I/II

Look up trial at NIH

Research Study Description

- Phase 1b:

-- 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)

- *For Eligibility information, please click on the "Look up trial at NIH" link above.

Other eligibility criteria may apply.



Research Study Number       2723.00
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
   

Keywords
Hematologic Malignancies; Lymphoproliferative Disease; Multiple Myeloma (MM)

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