353
Participants
Start Date
January 1, 2003
Primary Completion Date
November 1, 2005
Study Completion Date
October 1, 2008
CC-5013
Subjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle.
Dexamethasone
Subjects in the CC-5013/Dex and Placebo/Dex treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.
St. Vincent's Comprehensive Cancer Center, New York
New York Presbyterian Hospital, New York
MBCCOP Our Lady of Mercy Cancer Center New York Medical College, The Bronx
SUNY Upstate Medical University, Syracuse
Roswell Park Cancer Institute, Buffalo
University of Pittsburgh, Pittsburgh
University of Pennsylvania Cancer Center, Philadelphia
Johns Hopkins Medicine Department of Oncology, Baltimore
Duke University Medical Center, Durham
South Carolina Oncology Group, West Columbia
Charleston Hematology/Oncology P.A., Charleston
Medical University of SC, Charleston
Emory University, Atlanta
Mayo Clinic- Jacksonville, Jacksonville
University of Florida, Gainesville
University of Miami, Miami
Oncology Hematology Consultants, Sarasota
Clinical Research Consultants, Inc., Hoover
Ohio State University, Columbus
Cleveland Clinic Myeloma Program, Cleveland
University Of Michigan Comprehensive Cancer Center, Ann Arbor
Karmanos Cancer Institute, Detroit
University of Iowa Hospital Clinic, Iowa City
Mayo Clinic Cancer Center, Rochester
Loyola University Medical Center, Maywood
Washington University School of Medicine- Sherman Cancer Center, St Louis
Ocshner Clinical Foundation, New Orleans
UCLA School of Medicine, Los Angeles
City of Hope National Medical Center, Duarte
UCSF California, San Francisco
Kaiser Permanente Northwest Region Center for Health Research, Portland
Stanford University Medical Center, Division of Hematology, Stanford
Yale University School of Medicine, New Haven
H Lee Moffitt Cancer Center, Tampa
Medical College of Georgia, Augusta
Northwestern University Med Ctr, Chicago
Rush Cancer Institute Section of Hematology, Chicago
Indiana Cancer Research Institute, Indianapolis
Dana Farber Cancer Institute, Boston
Hackensack University Medical Center, Hackensack
Wake Forest University School of Medicine, Winston-Salem
Sarah Cannon Cancer Center, Nashville
MD Anderson Cancer Center, Houston
Froedtert Hospital/BMT Medical College of Wisconsin, Milwaukee
Cross Cancer Institute, Edmonton
Dalhousie University, Halifax
Princess Margaret Hospital, Toronto
Hospital Charles LeMoyne, Greenfield Park
McGill University, Montreal
Lead Sponsor
Celgene
INDUSTRY