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

NCT00050843 | Completed Phase 3

• 1 other identifier: THAL-MDS-001
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 38

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).

Conditions

Myelodysplastic Syndromes

Interventions

thalidomide DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Celgene Corporation: lead

Study Sites (38)

Scripps Cancer Center

La Jolla, California, 93037, United States

Location

Comprehensive Cancer Centers of the Desert

Palm Springs, California, 92262, United States

Location

Desert Hematology Oncology Medical Group INC

Rancho Mirage, California, 92270, United States

Location

Whittingham Cancer Center

Norwalk, Connecticut, 06856, United States

Location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

Southeast Florida Hematology-Oncology

Fort Lauderdale, Florida, 33308, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Northwest Medical Specialists

Arlington Heights, Illinois, 60004, United States

Location

Oncology Associates

Cedar Rapids, Iowa, 52403, United States

Location

Beaumont Cancer Center

Royal Oak, Michigan, 48073, United States

Location

SMDC Health Systems

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Jackson Oncology Associates PLLC

Jackson, Mississippi, 39202, United States

Location

Hematology Oncology Consultants Inc

St Louis, Missouri, 63136, United States

Location

Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Hematology Oncology Associates of NJ

Paramus, New Jersey, 07652, United States

Location

Summit Medical Group/Overlook Oncology Center

Summit, New Jersey, 07901, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Memorial Sloan Kettering Cancer Ctr

New York, New York, 10021, United States

Location

VAMC Northport

Northport, New York, 11768, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

South Shore Hem-Onc Assoc. PA

Rockville Centre, New York, 11570, United States

Location

Staten Island Unversity Hospital

Staten Island, New York, 10305, United States

Location

Westchester County Medical Center

Valhalla, New York, 10595, United States

Location

Buffalo Medical Group PC

Williamsville, New York, 14221, United States

Location

Northwestern Carolina Hematology Oncology PA

Hickory, North Carolina, 28602, United States

Location

Wake Forest Univ School of Medicine

Winston-Salem, North Carolina, 27157-1082, United States

Location

Oncology/Hematology Care Inc

Cincinnati, Ohio, 45246, United States

Location

Oregon Health & Science University

Portland, Oregon, 97201, United States

Location

Medical Oncology Associates

Kingston, Pennsylvania, 18704, United States

Location

Lancaster Cancer Center LTD

Lancaster, Pennsylvania, 17605, United States

Location

MCP Hahnemann University

Philadelphia, Pennsylvania, 19129, United States

Location

Western Pennsylvania Cancer Institute

Pittsburgh, Pennsylvania, 15224, United States

Location

Texas Oncology PA-BMT Center

Dallas, Texas, 75230, United States

Location

Central Utah Medical Clinic

Provo, Utah, 84604, United States

Location

InterMountain Hematology/Oncology

Salt Lake City, Utah, 84122, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Yakima Regional CancerCenter

Yakima, Washington, 98902, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 23, 2002
• First Posted: December 24, 2002
• Study Start: August 1, 2001
• Study Completion: February 1, 2004
• Last Updated: June 24, 2005

Record last verified: 2004-05

Locations

US (38)