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

This study has been completed.
Information provided by:
Celgene Identifier:
First received: August 27, 2002
Last updated: June 16, 2009
Last verified: June 2009
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

Resource links provided by NLM:

Further study details as provided by Celgene:

Estimated Enrollment: 25
Study Start Date: February 2002
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  • 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
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Please refer to this study by its identifier: NCT00044382

United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
Celgene Corporation
  More Information

Responsible Party: Deborah Ingenito, Celgene Corporation Identifier: NCT00044382     History of Changes
Other Study ID Numbers: CC-5013-MDS-501-001 
Study First Received: August 27, 2002
Last Updated: June 16, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene:

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Pathologic Processes
Precancerous Conditions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on April 27, 2016