NCT02412878

Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 478 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Carfilzomib	Carfilzomib was administered as an IV infusion
DRUG	Dexamethasone	Commercially available dexamethasone was obtained by the investigational site.

Timeline

• Start date: 2015-09-09
• Primary completion: 2017-06-15
• Completion: 2019-01-07
• First posted: 2015-04-09
• Last updated: 2022-09-23
• Results posted: 2018-12-13

Locations

140 sites across 20 countries: United States, Australia, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, New Zealand, Norway, Poland, Romania, Spain, Sweden, United Kingdom