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

This study has been completed.

First Received: December 23, 2002 Last Updated: June 23, 2005 History of Changes

Sponsor:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00050843

Purpose

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	Intervention	Phase
Myelodysplastic Syndromes	Drug: thalidomide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Anemia

Drug Information available for: Thalidomide

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Estimated Enrollment:	220
Study Start Date:	August 2001
Estimated Study Completion Date:	February 2004

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050843

Show 38 Study Locations

Sponsors and Collaborators

Celgene Corporation

More Information

No publications provided

Study ID Numbers:	THAL-MDS-001
Study First Received:	December 23, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00050843 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Disease
Precancerous Conditions
Thalidomide
Immunologic Factors
Antineoplastic Agents
Hematologic Diseases
Growth Substances
Myelodysplastic Syndromes
Physiological Effects of Drugs
Angiogenesis Inhibitors
Immunosuppressive Agents

Pharmacologic Actions
Anti-Bacterial Agents
Preleukemia
Neoplasms
Pathologic Processes
Therapeutic Uses
Syndrome
Growth Inhibitors
Angiogenesis Modulating Agents
Bone Marrow Diseases
Leprostatic Agents

ClinicalTrials.gov processed this record on November 27, 2009