NCT01311687

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study

A Phase 3, Muticenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-dose Dexamethasone Versus High-dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 455 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	pomalidomide	4 mg pomalidomide capsules administered orally
DRUG	Dexamethasone	40 mg dexamethasone (or 20 mg for participants \> 75 years of age) tablets administered orally

Timeline

• Start date: 2011-03-11
• Primary completion: 2013-03-01
• Completion: 2017-08-29
• First posted: 2011-03-09
• Last updated: 2018-10-24
• Results posted: 2014-04-30

Locations

94 sites across 16 countries: United States, Australia, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Russia, Spain, Sweden, Switzerland, United Kingdom