CompletedInterventionalPhase 3Updated Oct 31, 2018
A Study to Access the Safety/Efficacy of Thalidomide in the Treatment of Anemia in Patients With Myelodysplastic Syndromes | NCT00050843 | Trialant
CompletedInterventionalPhase 3Updated Jun 24, 2005
A Study to Access the Safety/Efficacy of Thalidomide in the Treatment of Anemia in Patients With Myelodysplastic Syndromes
ClinicalTrials.gov ID
NCT00050843
Lead Sponsor
Celgene CorporationINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
220
Last Update Posted
Jun 24, 2005Estimated
Start Date
Aug 2001
Completion Date
Feb 2004
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).
Myelodysplastic Syndromes
thalidomide
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility 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.
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
No central contacts
There are no central contacts for this study.
Scripps Cancer Center
La Jolla, California 93037, United States
Comprehensive Cancer Centers of the Desert
Palm Springs, California 92262, United States
Desert Hematology Oncology Medical Group INC
Rancho Mirage, California 92270, United States
Whittingham Cancer Center
Norwalk, Connecticut 06856, United States
VA Connecticut Healthcare System
West Haven, Connecticut 06516, United States
Southeast Florida Hematology-Oncology
Fort Lauderdale, Florida 33308, United States
Florida Cancer Specialists
Fort Myers, Florida 33901, United States
Northwest Medical Specialists
Arlington Heights, Illinois 60004, United States
Oncology Associates
Cedar Rapids, Iowa 52403, United States
Beaumont Cancer Center
Royal Oak, Michigan 48073, United States
SMDC Health Systems
Duluth, Minnesota 55805, United States
Mayo Clinic
Rochester, Minnesota 55905, United States
Jackson Oncology Associates PLLC
Jackson, Mississippi 39202, United States
Hematology Oncology Consultants Inc
St Louis, Missouri 63136, United States
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada 89106, United States
Hematology Oncology Associates of NJ
Paramus, New Jersey 07652, United States
Summit Medical Group/Overlook Oncology Center
Summit, New Jersey 07901, United States
Roswell Park Cancer Institute
Buffalo, New York 14263, United States
Memorial Sloan Kettering Cancer Ctr
New York, New York 10021, United States
VAMC Northport
Northport, New York 11768, United States
University of Rochester Cancer Center
Rochester, New York 14642, United States
South Shore Hem-Onc Assoc. PA
Rockville Centre, New York 11570, United States
Staten Island Unversity Hospital
Staten Island, New York 10305, United States
Westchester County Medical Center
Valhalla, New York 10595, United States
Buffalo Medical Group PC
Williamsville, New York 14221, United States
Northwestern Carolina Hematology Oncology PA
Hickory, North Carolina 28602, United States
Wake Forest Univ School of Medicine
Winston-Salem, North Carolina 27157-1082, United States