Phase 3 Study With Carfilzomib and Dexamethasone Versus Velcade and Dexamethasone for Relapsed Multiple Myeloma Patients (ENDEAVOR)

This Phase 3 study is a multicenter, open-label, randomized trial in patients with multiple myeloma whose disease has relapsed after at least 1 but not more than 3 prior therapeutic regimens. Patients must not have primary refractory disease (i.e., stable disease or progressive disease [PD] as best response to all prior therapies). Patients are allowed to have received prior carfilzomib or Velcade as long as they had at least a PR to prior therapy with carfilzomib or Velcade and at least a 6 month treatment-free interval since receiving carfilzomib or Velcade. Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month treatment-free interval.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma
Estimated Enrollment: 898
Study Start Date: June 2012
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Carfilzomib plus Dexamethasone (Cd)
- Active Comparator: Bortezomib (Velcade®) and Dexamethasone (Vd)


Related journal: Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study.