Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia
NCT00843882 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 247
Last updated 2026-05-01
Summary
This randomized phase III trial studies lenalidomide to see how well it works with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia. Lenalidomide may stop the growth of myelodysplastic syndrome by blocking blood flow to the cells. Colony stimulating factors, such as epoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known whether lenalidomide is more effective with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.
Conditions
- Anemia
- Chronic Myelomonocytic Leukemia
- De Novo Myelodysplastic Syndrome
- Myelodysplastic Syndrome
Interventions
- PROCEDURE
-
Bone Marrow Biopsy
Undergo bone marrow biopsy
- BIOLOGICAL
-
Epoetin Alfa
Given SC
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DRUG
-
Given PO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Amit K Verma · ECOG-ACRIN Cancer Research Group
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-01-29
- Primary Completion
- 2019-07-08
- Completion
- 2026-10-02
Countries
- United States
Study Locations
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