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

Primary Purpose

Myelodysplastic Syndromes

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
thalidomide
Sponsored by
Celgene Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Scripps Cancer Center
  • Comprehensive Cancer Centers of the Desert
  • Desert Hematology Oncology Medical Group INC
  • Whittingham Cancer Center
  • VA Connecticut Healthcare System
  • Florida Cancer Specialists
  • Southeast Florida Hematology-Oncology
  • Northwest Medical Specialists
  • Oncology Associates
  • Beaumont Cancer Center
  • SMDC Health Systems
  • Mayo Clinic
  • Jackson Oncology Associates PLLC
  • Hematology Oncology Consultants Inc
  • Southern Nevada Cancer Research Foundation
  • Hematology Oncology Associates of NJ
  • Summit Medical Group/Overlook Oncology Center
  • Roswell Park Cancer Institute
  • Memorial Sloan Kettering Cancer Ctr
  • VAMC Northport
  • University of Rochester Cancer Center
  • South Shore Hem-Onc Assoc. PA
  • Staten Island Unversity Hospital
  • Westchester County Medical Center
  • Buffalo Medical Group PC
  • Northwestern Carolina Hematology Oncology PA
  • Wake Forest Univ School of Medicine
  • Oncology/Hematology Care Inc
  • Oregon Health & Science University
  • Medical Oncology Associates
  • Lancaster Cancer Center LTD
  • MCP Hahnemann University
  • Western Pennsylvania Cancer Institute
  • Texas Oncology PA-BMT Center
  • Central Utah Medical Clinic
  • InterMountain Hematology/Oncology
  • Swedish Cancer Institute
  • Yakima Regional CancerCenter

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 23, 2002
Last Updated
June 23, 2005
Sponsor
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00050843
Brief Title
A Study to Access the Safety/Efficacy of Thalidomide in the Treatment of Anemia in Patients With Myelodysplastic Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2004
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Celgene Corporation

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
220 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
thalidomide

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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