CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 267 enrolled
Drug / intervention
Pomalidomide 0.5 mg +2 moredrug
Likely dose
Pomalidomide 0.5 mgfrom 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/NCT01178281
NCT01178281Phase 3Completed
CompareCT.gov

A Phase-3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Compare Efficacy and Safety of Pomalidomide in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis and Red Blood Cell-Transfusion-Dependence

Celgene·interventional·Posted Aug 10, 2010·Updated Jul 17, 2019

In Brief

A Phase 3 clinical trial evaluating Pomalidomide 0.5 mg, Placebo, and 1 other intervention for Primary Myelofibrosis and MPN-associated Myelofibrosis. Completed, enrolled 267 participants across 87 sites in 16 countries.

Detailed Summary

The objective of this study is to determine whether pomalidomide is safe and effective in reversing red blood cell (RBC)-transfusion-dependence in persons with myeloproliferative neoplasm (MPN)-associated myelofibrosis (global study) and in reversing anemia in Chinese with MPN-associated myelofibrosis and severe anemia not receiving RBC-transfusions (China extension study only)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Myelofibrosis, MPN-associated Myelofibrosis
CountriesAustralia, Austria, Belgium, Canada, China, France, Germany, Italy, Japan, Netherlands, Poland, Russia, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 10, 2010
Enrollment StartSep 8, 2010
Primary CompletionJan 1, 2013
Study CompletionMay 15, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.9 years ago

Interventions

Pomalidomide 0.5 mgdrug

Pomalidomide 0.5 mg capsule taken by mouth once daily. Immunomodulatory agent with demonstrated efficacy in the treatment of subjects with RBC-transfusion-dependence associated with MNP-associated myelofibrosis.

Placebodrug

Placebo Comparator to active drug; Placebo capsule taken by mouth once daily

Pomalidomidedrug

Pomalidomide 0.5 mg capsule taken by mouth once daily.