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

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

Hide Study Locations

Locations

United States, California
Comprehensive Cancer Centers of the Desert
Palm Springs, California, United States, 92262
Desert Hematology Oncology Medical Group INC
Rancho Mirage, California, United States, 92270
Scripps Cancer Center
La Jolla, California, United States, 93037
United States, Connecticut
Whittingham Cancer Center
Norwalk, Connecticut, United States, 06856
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
United States, Florida
Southeast Florida Hematology-Oncology
Ft. Lauderdale, Florida, United States, 33308
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
United States, Illinois
Northwest Medical Specialists
Arlington Heights, Illinois, United States, 60004
United States, Iowa
Oncology Associates
Cedar Rapids, Iowa, United States, 52403
United States, Michigan
Beaumont Cancer Center
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
SMDC Health Systems
Duluth, Minnesota, United States, 55805
United States, Mississippi
Jackson Oncology Associates PLLC
Jackson, Mississippi, United States, 39202
United States, Missouri
Hematology Oncology Consultants Inc
St. Louis, Missouri, United States, 63136
United States, Nevada
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Hematology Oncology Associates of NJ
Paramus, New Jersey, United States, 07652
Summit Medical Group/Overlook Oncology Center
Summit, New Jersey, United States, 07901
United States, New York
Staten Island Unversity Hospital
Staten Island, New York, United States, 10305
University of Rochester Cancer Center
Rochester, New York, United States, 14642
Memorial Sloan Kettering Cancer Ctr
New York, New York, United States, 10021
South Shore Hem-Onc Assoc. PA
Rockville Centre, New York, United States, 11570
Westchester County Medical Center
Valhalla, New York, United States, 10595
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
VAMC Northport
Northport, New York, United States, 11768
Buffalo Medical Group PC
Williamsville, New York, United States, 14221
United States, North Carolina
Northwestern Carolina Hematology Oncology PA
Hickory, North Carolina, United States, 28602
Wake Forest Univ School of Medicine
Winston Salem, North Carolina, United States, 27157-1082
United States, Ohio
Oncology/Hematology Care Inc
Cincinnati, Ohio, United States, 45246
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97201
United States, Pennsylvania
MCP Hahnemann University
Philadelphia, Pennsylvania, United States, 19129
Lancaster Cancer Center LTD
Lancaster, Pennsylvania, United States, 17605
Medical Oncology Associates
Kingston, Pennsylvania, United States, 18704
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Texas Oncology PA-BMT Center
Dallas, Texas, United States, 75230
United States, Utah
Central Utah Medical Clinic
Provo, Utah, United States, 84604
InterMountain Hematology/Oncology
Salt Lake City, Utah, United States, 84122
United States, Washington
Yakima Regional CancerCenter
Yakima, Washington, United States, 98902
Swedish Cancer Institute
Seattle, Washington, United States, 98104

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 22, 2009