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A study to access the safety/efficacy of thalidomide in the treatment of anemia in patients with Myelodysplastic Syndromes



A study to access the safety/efficacy of thalidomide in the treatment of anemia in patients with Myelodysplastic Syndromes

For Condition: Myelodysplastic Syndromes
Status: Completed
Sponsor(s): Celgene Corporation ,
Synopsis: The primary objective of the study is to determine the efficacy of thalidomide for the treatment of anemia in patients with myelodysplastic syndromes (MDS).
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 220

Location and Contact Information:

Southeast Florida Hematology-Oncology
Ft. Lauderdale,  Florida,  33308
United States
 

Texas Oncology PA-BMT Center
Dallas,  Texas,  75230
United States
 

Hematology Oncology Consultants Inc
St. Louis,  Missouri,  63136
United States
 

Desert Hematology Oncology Medical Group INC
Rancho Mirage,  California,  92270
United States
 

Lancaster Cancer Center LTD
Lancaster,  Pennsylvania,  17605
United States
 

VAMC Northport
Northport,  New York,  11768
United States
 

Oregon Health & Science University
Portland,  Oregon,  97201
United States
 

Roswell Park Cancer Institute
Buffalo,  New York,  14263
United States
 

Northwest Medical Specialists
Arlington Heights,  Illinois,  60004
United States
 

Mayo Clinic
Rochester,  Minnesota,  55905
United States
 

SMDC Health Systems
Duluth,  Minnesota,  55805
United States
 

Oncology Associates
Cedar Rapids,  Iowa,  52403
United States
 

Florida Cancer Specialists
Ft. Myers,  Florida,  33901
United States
 

Summit Medical Group/Overlook Oncology Center
Summit,  New Jersey,  07901
United States
 

InterMountain Hematology/Oncology
Salt Lake City,  Utah,  84122
United States
 

MCP Hahnemann University
Philadelphia,  Pennsylvania,  19129
United States
 

Southern Nevada Cancer Research Foundation
Las Vegas,  Nevada,  89106
United States
 

Jackson Oncology Associates PLLC
Jackson,  Mississippi,  39202
United States
 

Oncology/Hematology Care Inc
Cincinnati,  Ohio,  45246
United States
 

Medical Oncology Associates
Kingston,  Pennsylvania,  18704
United States
 

Memorial Sloan Kettering Cancer Ctr
New York City,  New York,  10021
United States
 

Whittingham Cancer Center
Norwalk,  Connecticut,  06856
United States
 

Central Utah Medical Clinic
Provo,  Utah,  84604
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
 

Beaumont Cancer Center
Royal Oak,  Michigan,  48073
United States
 

Western Pennsylvania Cancer Institute
Pittsburgh,  Pennsylvania,  15224
United States
 

Scripps Cancer Center
La Jolla,  California,  93037
United States
 

Northwestern Carolina Hematology Oncology PA
Hickory,  North Carolina,  28602
United States
 

Buffalo Medical Group PC
Williamsville,  New York,  14221
United States
 

Wake Forest Univ School of Medicine
Winston Salem,  North Carolina,  27157-1082
United States
 

Swedish Cancer Institute
Seattle,  Washington,  98104
United States
 

Yakima Regional CancerCenter
Yakima,  Washington,  98902
United States
 

VA Connecticut Healthcare System
West Haven,  Connecticut,  06516
United States
 

University of Rochester Cancer Center
Rochester,  New York,  14642
United States
 

Comprehensive Cancer Centers of the Desert
Palm Springs,  California,  92262
United States
 

Westchester County Medical Center
Valhalla,  New York,  10595
United States
 

Hematology Oncology Associates of NJ
Paramus,  New Jersey,  07652
United States
 


Additional Information:
Study ID Numbers:
  THAL-MDS-001; 
Study Start Date: August 2001
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050843

Other Myelodysplastic Syndromes Studies:
1. Reduced-Intensity Regimen Before Donor Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndromes

2. Radiolabeled Monoclonal Antibody Therapy Combined With Total-body Irradiation, Allogeneic Peripheral Stem Cell Transplantation, and Immunosuppression Therapy in Treating Older Patients Who Have Advanced Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia

3. Safety and efficacy of CC-5013 monotherapy in subjects with myelodysplastic syndromes associated with a del (5q) cytogenetic abnormality

4. Paricalcitol in Treating Patients With Myelodysplastic Syndrome

5. Bevacizumab in Treating Patients With Myelodysplastic Syndrome

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A study to access the safety/efficacy of thalidomide in the treatment of anemia in patients with Myelodysplastic Syndromes

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