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

June 23, 2005 updated by: Celgene Corporation
The primary objective of the study is to determine the efficacy of thalidomide for the treatment of anemia in patients with myelodysplastic syndromes (MDS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Study Completion

February 1, 2004

Study Registration Dates

First Submitted

December 23, 2002

First Submitted That Met QC Criteria

December 23, 2002

First Posted (Estimate)

December 24, 2002

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

May 1, 2004

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THAL-MDS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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