22
Participants
Start Date
October 28, 2013
Primary Completion Date
September 23, 2019
Study Completion Date
September 23, 2019
Oprozomib
Extended release (ER) tablets administered orally
Lenalidomide
Administered orally at a dose of 25 mg on days 1 through 21 of each 28-day cycle for a maximum of 24 cycles.
Dexamethasone
Administered at 20 mg, orally, on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle. After the first cycle the dose may be decreased to 10 mg/day in participants \> 75 years of age, at the discretion of the investigator.
Cyclophosphamide
Administered orally at 300 mg/m² (up to a maximum of 600 mg) on days 1, 8, and 15 of each 28-day cycle for a maximum of 8 cycles of therapy (approximately 8 months).
Clearview Cancer Institute, Huntsville
Providence St. Joseph's Hospital, Burbank
David Geffen School of Medicine at UCLA, Los Angeles
Monterey Bay Oncology Corp DBA Pacific Cancer Care, Salinas
Colorado Blood Cancer Institute, Denver
H. Lee Moffit Cancer Center & Research Institute, Tampa
University of Chicago Medical Center, Chicago
Indiana University Health Melvin and Bren Simon Cancer Center, Indianapolis
Center for Cancer & Blood Disorders, Bethesda
The University of North Carolina at Chapel Hill, Chapel Hill
Cleveland Clinic, Cleveland
University of Texas M.D. Anderson Cancer Center, Houston
Fred Hutchinson Cancer Research Center, Seattle
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee
Lead Sponsor
Amgen
INDUSTRY