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

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00044382
First received: August 27, 2002
Last updated: June 16, 2009
Last verified: June 2009
  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 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 Corporation:

Estimated Enrollment: 25
Study Start Date: February 2002
Primary Completion Date: January 2007 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Deborah Ingenito, Celgene Corporation
ClinicalTrials.gov 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 Corporation:
Revimid
CC5013
CC-5013

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Lenalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014