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Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

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ClinicalTrials.gov Identifier: NCT00044382
Recruitment Status : Completed
First Posted : August 29, 2002
Last Update Posted : June 17, 2009
Sponsor:
Information provided by:
Celgene

August 27, 2002
August 29, 2002
June 17, 2009
February 2002
January 2007   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00044382 on ClinicalTrials.gov Archive Site
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Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome
A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome
To estimate the percent of patients with myelodysplastic syndromes (MDS) who experience erythroid response and the interval to response with daily treatment of 25 mg of CC-5013 .
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Myelodysplastic Syndrome
Drug: CC-5013
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
Same as current
Not Provided
January 2007   (Final data collection date for primary outcome measure)
  • Diagnosis of de novo myelodysplastic syndrome of at least 12 weeks duration.
  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00044382
CC-5013-MDS-501-001
Yes
Not Provided
Not Provided
Deborah Ingenito, Celgene Corporation
Celgene Corporation
Not Provided
Not Provided
Celgene
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP