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

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene Corporation
• Treatments: Thalidomide

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.