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

Tracking Information
First Received Date ^ICMJE	August 27, 2002
Last Updated Date	June 16, 2009
Start Date ^ICMJE	February 2002
Primary Completion Date	January 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00044382 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome
Official Title ^ICMJE	A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome
Brief Summary	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 .
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Myelodysplastic Syndrome
Intervention ^ICMJE	Drug: CC-5013
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	25
Completion Date	August 2005
Primary Completion Date	January 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00044382
Responsible Party	Deborah Ingenito, Celgene Corporation
Study ID Numbers ^ICMJE	CC-5013-MDS-501-001
Study Sponsor ^ICMJE	Celgene Corporation
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Celgene Corporation
Verification Date	June 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP