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

Celgene

Status and phase

Completed

Phase 2

Conditions

Myelodysplastic Syndrome

Treatments

Drug: CC-5013

Study type

Interventional

Funder types

Industry

Identifiers

NCT00044382

CC-5013-MDS-501-001

Details and patient eligibility

About

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 .

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.