Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

• Status: Completed
• Trial end date: 2007-01-30
• Target enrollment: 0
• Participant gender: All

Summary

To estimate the percent of patients with myelodysplastic syndromes (MDS) who experience erythroid response and the interval to response with daily treatment of 25 mg of CC-5013 .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Lenalidomide; Thalidomide

Criteria

• Diagnosis of de novo myelodysplastic syndrome of at least 12 weeks duration.

• Baseline mean hemoglobin < 10.0 g/dL (untransfused) and/or be transfusion dependent defined by requiring at least 4 units of RBC in the 8 weeks prior to baseline.

• More than 30 days must have elapsed since any previous treatment for MDS, other than transfusion.

• Women must not be pregnant or lactating

• No use of another experimental study drug within 30 dy\ays of baseline

• Understand and sign written informed consent

• Able to adhere to study visit schedule, understand and comply with other protocol requirements.