Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome
NCT ID: NCT00044382
Last Updated: 2019-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2002-02-01
2007-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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CC-5013
Eligibility Criteria
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Inclusion Criteria
* Baseline mean hemoglobin \< 10.0 g/dL (untransfused) and/or be transfusion dependent defined by requiring at least 4 units of RBC in the 8 weeks prior to baseline.
* More than 30 days must have elapsed since any previous treatment for MDS, other than transfusion.
* Women must not be pregnant or lactating
* No use of another experimental study drug within 30 dy\\ays of baseline
* Understand and sign written informed consent
* Able to adhere to study visit schedule, understand and comply with other protocol requirements.
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Locations
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Arizona Cancer Center
Tucson, Arizona, United States
Countries
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References
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List A, Kurtin S, Roe DJ, Buresh A, Mahadevan D, Fuchs D, Rimsza L, Heaton R, Knight R, Zeldis JB. Efficacy of lenalidomide in myelodysplastic syndromes. N Engl J Med. 2005 Feb 10;352(6):549-57. doi: 10.1056/NEJMoa041668.
Other Identifiers
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CC-5013-MDS-501-001
Identifier Type: -
Identifier Source: org_study_id
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