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Thalidomide in anemia in MDS
NCT00050843Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2001
- Countries
- 1
- Sponsor
- Celgene Corporation
- Modality
- Small Molecules
- Drugs
- thalidomide
- Conditions
- myelodysplastic syndrome (MDS)
01
Overview
Phase 3, randomised, double-blind trial in myelodysplastic syndrome (MDS) comparing Thalidomide with Placebo (2 arms). Primary endpoint: Erythroid Response. Started Aug 2001; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Thalidomide
Thalidomide arm
Placebo
Placebo arm
03
Who it enrols
Patients with a diagnosis of myelodysplastic syndrome and life expectancy of at least 6 months. Women of childbearing potential must use two methods of contraception.
04
Endpoints
Primary
Erythroid Response
Secondary
Safety and Adverse Events
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