NCT01324947

Study to Evaluate the Safety and Efficacy of Pomalidomide Monotherapy in Subjects With Refractory or Relapsed Refractory Multiple Myeloma

Open-label, Multi-center, Single Arm Study For The Safety And Efficacy Of Pomalidomide Monotherapy For Subjects With Refractory Or Relapsed And Refractory Multiple Myeloma. A Companion Study For Clinical Trial CC-4047-MM003

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of pomalidomide monotherapy in subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in study CC-4047-MM-003 (NCT01311687) and discontinued treatment with high-dose dexamethasone due to disease progression.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	pomalidomide	Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-07-31
• Completion: 2014-07-31
• First posted: 2011-03-29
• Last updated: 2019-11-19
• Results posted: 2015-07-30

Locations

91 sites across 15 countries: Australia, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Russia, Spain, Sweden, Switzerland, United Kingdom