Spots Global Cancer Trial Database for Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma
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Trial Identification
Brief Title: Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma
Official Title: A Multicenter, Open-label Study to Determine the Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma
Study ID: NCT00065351
Conditions
Interventions
Study Description
Brief Summary: For each subject the study will consist of two phases: a treatment phase and a follow-up phase. Screening procedures will take place within 28 days of baseline. Treatment Phase: Subjects who qualify for enrollment into the study will receive single-agent CC-5013 in 28-day cycles. Study visits will occur every 4 weeks and hematologic and myeloma paraprotein laboratory assessments will occur every 2 weeks for the first 6 cycles and every 4 weeks thereafter. Follow-Up Phase: All subjects who discontinue the treatment phase for any reason will continue to be followed for survival and post-treatment phase anti-myeloma treatment.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Palo Verde Hematology Oncology, Glendale, Arizona, United States
Mayo Clinic, Scottsdale, Arizona, United States
Alta Bates Comprehensive Cancer Center, Berkeley, California, United States
Providence St. Joseph Medical Center/Cancer Center, Burbank, California, United States
Wilshire Oncology Medical Group, Inc., La Verne, California, United States
Institute for Myeloma and Bone, Los Angeles, California, United States
Cancer Care Associates, Redondo Beach, California, United States
Mayo Clinic, Jacksonville, Florida, United States
Northwest Georgia Oncology Centers, Marietta, Georgia, United States
Atlanta Cancer Care-Roswell, Roswell, Georgia, United States
Northwestern University Med Ctr, Chicago, Illinois, United States
Midwest Cancer Research Group, Skokie, Illinois, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Massachusetts, Worcester, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Nevada Cancer Center, Las Vegas, Nevada, United States
SUNY Health Science Center at Brooklyn, Brooklyn, New York, United States
St. Vincent's Comprehensive Cancer Center, New York, New York, United States
Carolina Hematology-Oncology Associates, Charlotte, North Carolina, United States
Cleveland Clinic Myeloma Program Hematology & Medical Oncology /R35, Cleveland, Ohio, United States
Western Pennsylvania Cancer Institute, Pittsburgh, Pennsylvania, United States
Swedish Cancer Institute, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Contact Details
Name: Robert Knight, MD
Affiliation: Celgene
Role: STUDY_DIRECTOR
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