Spots Global Cancer Trial Database for CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
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Trial Identification
Brief Title: CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
Official Title: A Multicenter, Randomized, Parallel-Group, Double-blind, Placebo-controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
Study ID: NCT00056160
Conditions
Study Description
Brief Summary: Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.
Detailed Description: This was a phase 3, multicenter, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of CC-5013 plus oral pulse high-dose dexamethasone and oral pulse high-dose dexamethasone therapy alone in subjects with relapsed or refractory multiple myeloma. Eligible subjects were randomized in a 1:1 ratio to 1 of 2 treatment groups: Subjects in the CC-5013/Dex treatment group took 25 mg of CC-5013 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; Subjects in the Placebo/Dex treatment group took 1 placebo capsule on Days 1 to 28 of each 28-day cycle. Subjects in both 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Clinical Research Consultants, Inc., Hoover, Alabama, United States
City of Hope National Medical Center, Duarte, California, United States
UCLA School of Medicine, Los Angeles, California, United States
UCSF California, San Francisco, California, United States
Stanford University Medical Center, Division of Hematology, Stanford, California, United States
Yale University School of Medicine, New Haven, Connecticut, United States
University of Florida, Gainesville, Florida, United States
Mayo Clinic- Jacksonville, Jacksonville, Florida, United States
University of Miami, Miami, Florida, United States
Oncology Hematology Consultants, Sarasota, Florida, United States
H Lee Moffitt Cancer Center, Tampa, Florida, United States
Emory University, Atlanta, Georgia, United States
Medical College of Georgia, Augusta, Georgia, United States
Northwestern University Med Ctr, Chicago, Illinois, United States
Rush Cancer Institute Section of Hematology, Chicago, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Indiana Cancer Research Institute, Indianapolis, Indiana, United States
University of Iowa Hospital Clinic, Iowa City, Iowa, United States
Ocshner Clinical Foundation, New Orleans, Louisiana, United States
Johns Hopkins Medicine Department of Oncology, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University Of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Washington University School of Medicine- Sherman Cancer Center, Saint Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
St. Vincent's Comprehensive Cancer Center, New York, New York, United States
New York Presbyterian Hospital, New York, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
MBCCOP Our Lady of Mercy Cancer Center New York Medical College, The Bronx, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest University School of Medicine, Winston-Salem, North Carolina, United States
Cleveland Clinic Myeloma Program, Cleveland, Ohio, United States
Ohio State University, Columbus, Ohio, United States
Kaiser Permanente Northwest Region Center for Health Research, Portland, Oregon, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
Charleston Hematology/Oncology P.A., Charleston, South Carolina, United States
Medical University of SC, Charleston, South Carolina, United States
South Carolina Oncology Group, West Columbia, South Carolina, United States
Sarah Cannon Cancer Center, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Froedtert Hospital/BMT Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
Dalhousie University, Halifax, Nova Scotia, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Hospital Charles LeMoyne, Greenfield Park, Quebec, Canada
McGill University, Montreal, Quebec, Canada
Contact Details
Name: Robert Knight, MD
Affiliation: Celgene Corporation
Role: STUDY_DIRECTOR
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