A Phase 2, Prospective, Randomized, Multicenter, Double-blind, Active-control, Parallel-group Study to Determine the Safety of and to Select a Treatment Regimen of CC-4047 (Pomalidomide) Either as Single-agent or in Combination With Prednisone to Study Further in Subjects With Myelofibrosis With Myeloid Metaplasia
Subjects will remain on study treatment in the Double Blind Treatment Phase for up to 12
cycles (336 days; 12 cycles of 28 days each). Study assessments and serial measurements of
safety and efficacy will be performed as outlined in schedule of assessments.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Best overall response as determined by International Working Group Criteria
Up to 168 days
Yes
Robert Peter Gale, MD, PhD
Study Director
Celgene Corporation
United States: Food and Drug Administration
CC-4047-MMM-001
NCT00463385
December 2006
January 2013
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
UCLA School of Medicine Hematology/Oncology | Los Angeles, California 90095 |
New York Presbyterian HospitalWeill Medical College of Cornell University | New York, New York 10021 |
MD Anderson Cancer Center Leukemia Department | Houston, Texas 77030 |