At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 enrolled
Drug / intervention
Lenalidomide +1 moredrug
Likely dose
Recombinant human erythropoietin 40,000 unitsfrom 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.
A Pharmacokinetic And Pharmacodynamic Study Of Oral Lenalidomide (Revlimid) In Subjects With Low- Or Intermediate-1-Risk Myelodysplastic Syndromes
In Brief
A Phase 2 clinical trial evaluating Lenalidomide and Recombinant human erythropoietin for Low- or Intermediate-1-risk Myelodysplastic Syndrome (MDS). Completed, enrolled 40 participants across 1 site.
Detailed Summary
The purpose of this study is to assess pharmacokinetic and pharmacodynamic characteristics of oral lenalidomide monotherapy administered to patients with Low- or Intermediate-1-risk Myelodysplastic Syndrome (MDS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2005
Primary CompletionApr 2006
Study CompletionMay 2009
First PostedJun 2009
TodayJul 2026
First PostedJun 1, 2009
Enrollment StartJan 1, 2005
Primary CompletionApr 1, 2006
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.1 years ago
Interventions
Lenalidomidedrug
Lenalidomide 5-mg capsules for oral administration
Recombinant human erythropoietindrug
Recombinant human erythropoietin (rhu-EPO) subcutaneous injection of 40,000 units.