CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 247 enrolled
Drug / intervention
Epoetin Alfa +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00843882
NCT00843882Phase 3Active

Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment With Lenalidomide (Revlimid®)) Alone and in Combination With Epoetin Alfa (Procrit®)) in Subjects With Low- or Intermediate-1 Risk MDS and Symptomatic Anemia

National Cancer Institute (NCI)·interventional·Posted Feb 13, 2009·Updated May 29, 2026

In Brief

A Phase 3 clinical trial evaluating Bone Marrow Biopsy, Epoetin Alfa, and 2 other interventions for Anemia and 3 related conditions. Active but no longer recruiting, targeting 247 participants across 508 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3Active
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 13, 2009
Enrollment StartJan 29, 2009
Primary CompletionJul 8, 2019
Study CompletionOct 2, 2026
TodayJul 2, 2026
Enrollment to primary: 10.4 yearsPosted 17.4 years ago

Interventions

Bone Marrow Biopsyprocedure

Undergo bone marrow biopsy

Epoetin Alfabiological

Given SC

Laboratory Biomarker Analysisother

Correlative studies

Lenalidomidedrug

Given PO