Clinical trial NCT00050843: A Study to Access the Safety/Efficacy of Thalidomide in the Treatment of Anemia in Patients With Myelodysplastic Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myelodysplastic Syndromes
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2002-12-24
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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 outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Cancer Center
state: California
city: Palm Springs
country: United States
facility: Comprehensive Cancer Centers of the Desert
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group INC
state: California
city: Norwalk
country: United States
facility: Whittingham Cancer Center
state: Connecticut
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Ft. Lauderdale
country: United States
facility: Southeast Florida Hematology-Oncology
state: Florida
city: Arlington Heights
country: United States
facility: Northwest Medical Specialists
state: Illinois
city: Cedar Rapids
country: United States
facility: Oncology Associates
state: Iowa
city: Royal Oak
country: United States
facility: Beaumont Cancer Center
state: Michigan
city: Duluth
country: United States
facility: SMDC Health Systems
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: Jackson Oncology Associates PLLC
state: Mississippi
city: St. Louis
country: United States
facility: Hematology Oncology Consultants Inc
state: Missouri
city: Las Vegas
country: United States
facility: Southern Nevada Cancer Research Foundation
state: Nevada
city: Paramus
country: United States
facility: Hematology Oncology Associates of NJ
state: New Jersey
city: Summit
country: United States
facility: Summit Medical Group/Overlook Oncology Center
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Ctr
state: New York
city: Northport
country: United States
facility: VAMC Northport
state: New York
city: Rochester
country: United States
facility: University of Rochester Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: South Shore Hem-Onc Assoc. PA
state: New York
city: Staten Island
country: United States
facility: Staten Island Unversity Hospital
state: New York
city: Valhalla
country: United States
facility: Westchester County Medical Center
state: New York
city: Williamsville
country: United States
facility: Buffalo Medical Group PC
state: New York
city: Hickory
country: United States
facility: Northwestern Carolina Hematology Oncology PA
state: North Carolina
city: Winston Salem
country: United States
facility: Wake Forest Univ School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology/Hematology Care Inc
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Kingston
country: United States
facility: Medical Oncology Associates
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster Cancer Center LTD
state: Pennsylvania
city: Philadelphia
country: United States
facility: MCP Hahnemann University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Western Pennsylvania Cancer Institute
state: Pennsylvania
city: Dallas
country: United States
facility: Texas Oncology PA-BMT Center
state: Texas
city: Provo
country: United States
facility: Central Utah Medical Clinic
state: Utah
city: Salt Lake City
country: United States
facility: InterMountain Hematology/Oncology
state: Utah
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Yakima
country: United States
facility: Yakima Regional CancerCenter
state: Washington
Study officials:
References: