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Brief Title: Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma
Official Title: (INTREPID-1) A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Oprozomib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Study ID: NCT02939183
Brief Summary: A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma.
Detailed Description: A multicenter, non-randomized, open-label, dose-exploration study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma. The study will be conducted in two parts. Part 1 will evaluate the formulations of oprozomib in combination with dexamethasone only. Part 2 will evaluate the formulations of oprozomib administered at increasing dose levels (dose escalation) in combination with pomalidomide and dexamethasone.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, West Hollywood, California, United States
Research Site, Tampa, Florida, United States
Research Site, Atlanta, Georgia, United States
Research Site, Chicago, Illinois, United States
Research Site, Bethesda, Maryland, United States
Research Site, Saint Louis, Missouri, United States
Research Site, Hackensack, New Jersey, United States
Research Site, New York, New York, United States
Research Site, Charlotte, North Carolina, United States
Research Site, Canton, Ohio, United States
Research Site, Cleveland, Ohio, United States
Research Site, San Antonio, Texas, United States
Research Site, Milwaukee, Wisconsin, United States
Research Site, Clayton, Victoria, Australia
Research Site, Murdoch, Western Australia, Australia
Research Site, Perth, Western Australia, Australia
Research Site, Gent, , Belgium
Research Site, Calgary, Alberta, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Rotterdam, , Netherlands
Research Site, Salamanca, Castilla León, Spain
Research Site, Pamplona, Navarra, Spain
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR