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Efficacy and Safety Study of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes


A Multicenter, Single-Arm, Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes




This study is a multi-center, single-arm, open-label study of oral CC-5013 monotherapy administered at a dose of 10 mg daily on Days 1-21 every 28 days (28-day cycles) to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk MDS who do not have a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of first day of study drug treatment. Subjects will receive study drug (CC-5013) in 28-day cycles for up to 6 cycles, or until bone marrow disease progression or progression/relapse following erythroid hematologic improvement (Appendix I) is documented. Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments.

Study Status: Completed


Condition Intervention Phase
Myelodysplastic Syndromes Drug: CC-5013 Phase 2

Verified by Celgene Corporation April, 2013

Sponsored by: Celgene Corporation
Information provided by: Celgene Corporation identifier: NCT00064974

Study Type: Interventional

Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

Robert Knight, MD., Study Director

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