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

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT00044382

Collaborator

(none)

Enrollment

Location

59.9

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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 .

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndrome	Drug: CC-5013	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

Actual Study Start Date :

Feb 1, 2002

Actual Primary Completion Date :

Jan 1, 2007

Actual Study Completion Date :

Jan 30, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.