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Brief Title: Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
Official Title: Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
Study ID: NCT01832727
Brief Summary: The primary objectives are: Phase 1b: * To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of oprozomib given orally, once daily, on 2 different schedules. * To evaluate safety and tolerability Phase 2: * To estimate the overall response rate (ORR). * To evaluate safety and tolerability
Detailed Description: The purpose of the Phase 1b portion of the study was to determine the maximum tolerated dose (MTD), the recommended phase 2 dose (RP2D), safety, and pharmacokinetics (PK) of oprozomib administered orally once daily in combination with dexamethasone, in participants with relapsed and/or refractory multiple myeloma, using a 3 + 3 dose-escalation scheme with and without step-up dosing. The MTD was defined as the highest dose level at which fewer than 33% of participants had a dose-limiting toxicity (DLT).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
University of Kansas Cancer Center and Medical Pavilion, Westwood, Kansas, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Division of Hematology/ Oncology, UNC at Chapel Hill, Chapel Hill, North Carolina, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
CHRU, Hopital Huriez - Department of Hematology, Lille CEDEX, , France
CHU Hotel Dieu - Service d'Hematologie Clinique, NANTES Cedex, , France
CHU de NANCY - Hopital de BRABOlS, Vandoeuvre Les Nancy, , France
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR