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

NCT ID: NCT00050843

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2004-02-29

Brief Summary

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

Detailed Description

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Conditions

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Myelodysplastic Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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thalidomide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene Corporation

INDUSTRY

Sponsor Role lead

Locations

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Scripps Cancer Center

La Jolla, California, United States

Site Status

Comprehensive Cancer Centers of the Desert

Palm Springs, California, United States

Site Status

Desert Hematology Oncology Medical Group INC

Rancho Mirage, California, United States

Site Status

Whittingham Cancer Center

Norwalk, Connecticut, United States

Site Status

VA Connecticut Healthcare System

West Haven, Connecticut, United States

Site Status

Southeast Florida Hematology-Oncology

Fort Lauderdale, Florida, United States

Site Status

Florida Cancer Specialists

Fort Myers, Florida, United States

Site Status

Northwest Medical Specialists

Arlington Heights, Illinois, United States

Site Status

Oncology Associates

Cedar Rapids, Iowa, United States

Site Status

Beaumont Cancer Center

Royal Oak, Michigan, United States

Site Status

SMDC Health Systems

Duluth, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Jackson Oncology Associates PLLC

Jackson, Mississippi, United States

Site Status

Hematology Oncology Consultants Inc

St Louis, Missouri, United States

Site Status

Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Site Status

Hematology Oncology Associates of NJ

Paramus, New Jersey, United States

Site Status

Summit Medical Group/Overlook Oncology Center

Summit, New Jersey, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Memorial Sloan Kettering Cancer Ctr

New York, New York, United States

Site Status

VAMC Northport

Northport, New York, United States

Site Status

University of Rochester Cancer Center

Rochester, New York, United States

Site Status

South Shore Hem-Onc Assoc. PA

Rockville Centre, New York, United States

Site Status

Staten Island Unversity Hospital

Staten Island, New York, United States

Site Status

Westchester County Medical Center

Valhalla, New York, United States

Site Status

Buffalo Medical Group PC

Williamsville, New York, United States

Site Status

Northwestern Carolina Hematology Oncology PA

Hickory, North Carolina, United States

Site Status

Wake Forest Univ School of Medicine

Winston-Salem, North Carolina, United States

Site Status

Oncology/Hematology Care Inc

Cincinnati, Ohio, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Medical Oncology Associates

Kingston, Pennsylvania, United States

Site Status

Lancaster Cancer Center LTD

Lancaster, Pennsylvania, United States

Site Status

MCP Hahnemann University

Philadelphia, Pennsylvania, United States

Site Status

Western Pennsylvania Cancer Institute

Pittsburgh, Pennsylvania, United States

Site Status

Texas Oncology PA-BMT Center

Dallas, Texas, United States

Site Status

Central Utah Medical Clinic

Provo, Utah, United States

Site Status

InterMountain Hematology/Oncology

Salt Lake City, Utah, United States

Site Status

Swedish Cancer Institute

Seattle, Washington, United States

Site Status

Yakima Regional CancerCenter

Yakima, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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THAL-MDS-001

Identifier Type: -

Identifier Source: org_study_id