A Phase II Open Label Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome
- 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
- 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
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
- Myelodysplastic Syndrome
- Myelodysplastic Syndromes
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