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A Study to Access the Safety/Efficacy of Thalidomide in the Treatment of Anemia in Patients With Myelodysplastic Syndromes

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: NCT00050843
Recruitment Status : Completed
First Posted : December 24, 2002
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
Celgene

Study Description
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Brief Summary:
The primary objective of the study is to determine the efficacy of thalidomide for the treatment of anemia in patients with myelodysplastic syndromes (MDS).

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Drug: thalidomide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 2001
Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Thalidomide

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Eligible patients must have a diagnosis of myelodysplastic syndrome
  • Life expectancy of at least 6 months.
  • Patients must be able to adhere to the study visit schedule and other protocol requirements.
  • Patients must understand and voluntarily sign an informed consent document.
  • Women of childbearing potential (WCBP) must agree to practice abstinence or to use TWO methods of contraception beginning 4 weeks prior to the start of study medication and throughout the course of treatment.
  • Males must use barrier contraception when engaging in reproductive sexual activity with women of childbearing potential.
Contacts and Locations
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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): NCT00050843


Locations
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Sponsors and Collaborators
Celgene Corporation
More Information
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ClinicalTrials.gov Identifier: NCT00050843    
Other Study ID Numbers: THAL-MDS-001
First Posted: December 24, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2004
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Thalidomide
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents