At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 455 enrolled
Drug / intervention
pomalidomide +1 moredrug
Likely dose
pomalidomide 4 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.
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
In Brief
A Phase 3 clinical trial evaluating pomalidomide and Dexamethasone for Multiple Myeloma. Completed, enrolled 455 participants across 94 sites in 16 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesAustralia, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Russia, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2011
Enrollment StartMar 2011
Primary CompletionMar 2013
Study CompletionAug 2017
TodayJul 2026
First PostedMar 9, 2011
Enrollment StartMar 11, 2011
Primary CompletionMar 1, 2013
Study CompletionAug 29, 2017
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 15.3 years ago
Interventions
pomalidomidedrug
4 mg pomalidomide capsules administered orally
Dexamethasonedrug
40 mg dexamethasone (or 20 mg for participants \> 75 years of age) tablets administered orally