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

Celgene

Status and phase

Completed

Phase 3

Conditions

Myelodysplastic Syndromes

Treatments

Drug: thalidomide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00050843

THAL-MDS-001

Details and patient eligibility

About

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

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.