A Study in Subjects With Relapsed and Refractory Multiple Myeloma Receiving Carfilzomib in Combination With Dexamethasone, Comparing Once-weekly Versus Twice-weekly Carfilzomib Dosing (ARROW)
The purpose of the study is to compare once-weekly carfilzomib dosing in combination with dexamethasone to twice-weekly carfilzomib dosing in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma, previously treated with bortezomib and an immunomodulatory agent (IMiD).
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 478 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: September 30, 2015
Actual Primary Completion Date: June 15, 2017
Estimated Study Completion Date: December 20, 2019
Arms:
- Active Comparator: Arm A: Once-weekly Carfilzomib with Dexamethasone
- Active Comparator: Arm B: Twice-weekly Carfilzomib with Dexamethasone
Related journal:
- Once weekly versus twice weekly carfilzomib dosing in patients with relapsed and refractory multiple myeloma (A.R.R.O.W.): interim analysis results of a randomised, phase 3 study.
Category | Value |
---|---|
Date last updated at source | 2017-11-07 |
Study type(s) | Interventional |
Expected enrolment | 478 |
Study start date | 2015-09-30 |
Estimated primary completion date | 2017-06-15 |