CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 929 enrolled
Drug / intervention
Carfilzomib +2 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.

Search/NCT01568866
NCT01568866Phase 3Completed
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A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma

Amgen·interventional·Posted Apr 2, 2012·Updated Nov 14, 2022

In Brief

A Phase 3 clinical trial evaluating Carfilzomib, Bortezomib, and 1 other intervention for Multiple Myeloma. Completed, enrolled 929 participants across 241 sites in 27 countries.

Detailed Summary

The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesAustralia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, New Zealand, Poland, Romania, Russia, Singapore, Slovakia, South Korea, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 2, 2012
Enrollment StartJun 20, 2012
Primary CompletionNov 10, 2014
Study CompletionFeb 5, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 14.3 years ago

Interventions

Carfilzomibdrug

Carfilzomib is administered over 30 minutes as an infusion.

Bortezomibdrug

Bortezomib is administered as a 3-5 second bolus IV injection or SC injection (in accordance with regulatory approval)

Dexamethasonedrug

Tablet for oral administration; On days when carfilzomib or bortezomib was administered, the dexamethasone was to be given 30 minutes to 4 hours prior to the carfilzomib or bortezomib dose.