Ft. Lauderdale, Florida 33308

  • Myelodysplastic Syndromes

Purpose:

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


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.


Study is Available At:


Original ID:

THAL-MDS-001


NCT ID:

NCT00050843


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:

Completed


Study Phase:

Phase 3


Genders:

Both


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:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

220


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
Name:thalidomide

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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