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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00044382
Recruitment Status : Completed
First Posted : August 29, 2002
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

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 .

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: CC-5013 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : February 1, 2002
Actual Primary Completion Date : January 1, 2007
Actual Study Completion Date : January 30, 2007

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044382


Locations
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United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
Celgene
Publications:
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00044382    
Other Study ID Numbers: CC-5013-MDS-501-001
First Posted: August 29, 2002    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Keywords provided by Celgene:
Revimid
CC5013
CC-5013
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents