At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 478 enrolled
Drug / intervention
Carfilzomib +1 moredrug
Likely dose
Not stated in 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 Randomized, Open-label, Phase 3 Study in Subjects With Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib in Combination With Dexamethasone, Comparing Once-weekly Versus Twice-weekly Carfilzomib Dosing
In Brief
A Phase 3 clinical trial evaluating Carfilzomib and Dexamethasone for Multiple Myeloma. Completed, enrolled 478 participants across 140 sites in 20 countries.
Detailed Summary
The purpose of the study is to compare the progression-free survival (PFS) of once-weekly carfilzomib dosing in combination with dexamethasone to twice-weekly carfilzomib dosing in combination with dexamethasone in adults with relapsed and refractory multiple myeloma, previously treated with bortezomib and an immunomodulatory agent (IMiD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesAustralia, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, New Zealand, Norway, Poland, Romania, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 2015
Enrollment StartSep 2015
Primary CompletionJun 2017
Study CompletionJan 2019
TodayJul 2026
First PostedApr 9, 2015
Enrollment StartSep 9, 2015
Primary CompletionJun 15, 2017
Study CompletionJan 7, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.2 years ago
Interventions
Carfilzomibdrug
Carfilzomib was administered as an IV infusion
Dexamethasonedrug
Commercially available dexamethasone was obtained by the investigational site.