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

Tracking Information
First Submitted Date ICMJE	August 27, 2002
First Posted Date ICMJE	August 29, 2002
Last Update Posted Date	June 17, 2009
Study Start Date ICMJE	February 2002
Actual Primary Completion Date	January 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00044382 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
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	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Myelodysplastic Syndrome
Intervention ICMJE	Drug: CC-5013
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: June 23, 2005)	25
Original Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Actual 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00044382
Other Study ID Numbers ICMJE	CC-5013-MDS-501-001
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Deborah Ingenito, Celgene Corporation
Study Sponsor ICMJE	Celgene Corporation
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Celgene
Verification Date	June 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP