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Lenalidomide Monotherapy in MDS (MDS-002)
NCT00064974Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2003
- Primary completion
- Jan 2007
- Countries
- 15
- Sponsor
- Celgene Corporation
- Modality
- Small Molecules
- Drugs
- lenalidomide
- Conditions
- myelodysplastic syndrome (MDS)
01
Overview
Phase 2, open-label, single-arm trial of lenalidomide in myelodysplastic syndrome (MDS), sponsored by Celgene Corporation. Primary endpoint: Red Blood Cell Transfusion Independence. Started Jun 2003; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
CC-5013 Monotherapy
Lenalidomide 10 mg daily
03
Who it enrols
Adults with low- or intermediate-1-risk MDS without del(5q) who are RBC transfusion-dependent.
04
Endpoints
Primary
Red Blood Cell Transfusion Independence
Secondary
Decrease in RBC Transfusion Requirement
Platelet Response
Neutrophil Response
Bone Marrow Response
Duration of Response
Hemoglobin Concentration
Number of Participants with Adverse Events
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