Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003
NCT ID: NCT01099267
Last Updated: 2019-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
54 participants
OBSERVATIONAL
2010-03-01
2010-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Lenalidomide
No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Must understand and be able to give informed consent (if a subject is deceased, proper legal consent (i.e. next of kin, legal representative) will be obtained prior to collection of data).
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Barry Skikne, MD
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States
Stanford University Cancer Center
Stanford, California, United States
Cancer & Blood Disease Center
Lecanto, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, United States
Hematology Oncology Associates of Illinois
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
John Hopkins University Hospital
Baltimore, Maryland, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Wake Forest University
Winston-Salem, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
St. Johannes Hospital
Duisburg, , Germany
Countries
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References
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Gohring G, Giagounidis A, Busche G, Hofmann W, Kreipe HH, Fenaux P, Hellstrom-Lindberg E, Schlegelberger B. Cytogenetic follow-up by karyotyping and fluorescence in situ hybridization: implications for monitoring patients with myelodysplastic syndrome and deletion 5q treated with lenalidomide. Haematologica. 2011 Feb;96(2):319-22. doi: 10.3324/haematol.2010.026658. Epub 2010 Nov 25.
List A, Dewald G, Bennett J, Giagounidis A, Raza A, Feldman E, Powell B, Greenberg P, Thomas D, Stone R, Reeder C, Wride K, Patin J, Schmidt M, Zeldis J, Knight R; Myelodysplastic Syndrome-003 Study Investigators. Lenalidomide in the myelodysplastic syndrome with chromosome 5q deletion. N Engl J Med. 2006 Oct 5;355(14):1456-65. doi: 10.1056/NEJMoa061292.
Other Identifiers
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CC-5013-MDS-003E
Identifier Type: OTHER
Identifier Source: secondary_id
CC-5013-MDS-009
Identifier Type: -
Identifier Source: org_study_id
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