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

This study has been completed.

Sponsored by:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00044382

Purpose

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 .

Condition	Intervention	Phase
Myelodysplastic Syndrome	Drug: CC-5013	Phase II

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

Further study details as provided by Celgene Corporation:

Estimated Enrollment:	25
Study Start Date:	February 2002
Estimated Study Completion Date:	August 2005
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044382

Locations

United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724

Sponsors and Collaborators

Celgene Corporation

More Information

Responsible Party:	Celgene Corporation ( Deborah Ingenito )
Study ID Numbers:	CC-5013-MDS-501-001
Study First Received:	August 27, 2002
Last Updated:	February 8, 2008
ClinicalTrials.gov Identifier:	NCT00044382
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

Revimid
CC5013
CC-5013

Study placed in the following topic categories:

Myelodysplastic syndromes
Preleukemia
Precancerous Conditions
Hematologic Diseases

Myelodysplasia
Myelodysplastic Syndromes
Lenalidomide
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease
Antineoplastic Agents

Therapeutic Uses
Syndrome
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009