Ft. Lauderdale, Florida 33308

  • Myelodysplastic Syndromes


The primary objective of the study is to determine the efficacy of thalidomide for the treatment of anemia in patients with myelodysplastic syndromes (MDS).


- 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.

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

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

Official Title:

Overall Status:


Study Phase:

Phase 3



Minimum Age:

18 Years

Maximum Age:

80 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Celgene Corporation

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Study Dates

Start Date:August 2001
Completion Date:February 2004
Verification Date:May 2004
Last Changed Date:June 23, 2005
First Received Date:December 23, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Celgene Corporation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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