Efficacy and Safety Study of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes
Status:
Completed
Trial end date:
2007-02-01
Target enrollment:
Participant gender:
Summary
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.