At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 11 enrolled

Drug / intervention

Lenalidomidedrug

Likely dose

Lenalidomide 10mgfrom 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/NCT00812968

NCT00812968Phase 2Completed

Compare CT.gov

A Multicenter, Single-arm Study to Assess the Safety, Pharmacokinetics and Efficacy of Lenalidomide in Japanese Subjects With Low- or Intern=Mediate-1-risk Myelodysplastic Syndromes (MDS) Associated With a Deletion 5 (q31-33) Abnormality and Symptomatic Anemia

Celgene·interventional·Posted Dec 22, 2008·Updated Nov 19, 2019

In Brief

A Phase 2 clinical trial evaluating Lenalidomide for Myelodysplastic Syndromes. Completed, enrolled 11 participants across 6 sites.

Detailed Summary

The purpose of this clinical experience study is to determine whether CC-5013 is safe and effective (to include studying the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body \[pharmacokinetics\]) in Japanese subjects with low- or intermediate-1-risk MDS (IPSS risk categories) associated with a deletion 5(q31-33) abnormality and symptomatic anemia.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMyelodysplastic Syndromes

CountriesJapan

Collaborators--

Timeline

Phase 2CompletedFinished

20082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartSep 2007

First PostedDec 2008

Primary CompletionSep 2010

TodayJul 2026

First PostedDec 22, 2008

Enrollment StartSep 1, 2007

Primary CompletionSep 1, 2010

TodayJul 2, 2026

Enrollment to primary: 3 yearsPosted 17.5 years ago

Interventions

Lenalidomidedrug

Oral 10mg daily on Days 1-21 days every 28 days until disease progression/relapse or CC-5013 is permanently discontinued for any reason for up to 156 weeks (3 years).