Oprozomib and Dexamethasone,in Combination With Lenalidomide or Oral Cyclophosphamide to Treat Newly Diagnosed Multiple Myeloma

Stopped early · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

The primary objectives of this study included the following: Phase 1b: * To establish the maximum tolerated dose (MTD) of oprozomib given in combination with lenalidomide and dexamethasone (ORd) or with cyclophosphamide and dexamethasone (OCyd) * To evaluate the safety and tolerability of oprozomib and dexamethasone administered in combination with lenalidomide or oral cyclophosphamide Phase 2: * To estimate the antitumor activity of each combination regimen, as measured by overall response rate (ORR) and complete response rate (CRR) * To evaluate the safety and tolerability of each combination regimens, as assessed by the type, incidence, severity and seriousness of adverse events, and abnormalities in selected laboratory analytes

Key facts

Study ID

NCT01881789

Run by

Amgen

People needed

22

Starts

2013-10-28

Expected to finish

2019-09-23

Last updated by the study team

2022-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Clearview Cancer Institute — Huntsville, Alabama, United States
• Providence St. Joseph's Hospital — Burbank, California, United States
• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Monterey Bay Oncology Corp DBA Pacific Cancer Care — Salinas, California, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• H. Lee Moffit Cancer Center & Research Institute — Tampa, Florida, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Indiana University Health Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Center for Cancer & Blood Disorders — Bethesda, Maryland, United States
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• Froedtert Hospital and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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