At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 74 enrolled
Drug / intervention
pomalidomidedrug
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.
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
In Brief
A Phase 3 clinical trial evaluating pomalidomide for Multiple Myeloma. Completed, enrolled 74 participants across 91 sites in 15 countries.
Detailed 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.
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
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
First PostedMar 2011
Primary CompletionJul 2014
TodayJul 2026
First PostedMar 29, 2011
Enrollment StartMar 1, 2011
Primary CompletionJul 31, 2014
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 15.3 years ago
Interventions
pomalidomidedrug
Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity