NCT01080391

Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 792 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting.

Detailed description

This is a Phase 3, randomized, open-label, multicenter study comparing two treatment regimens for adults with relapsed multiple myeloma. Eligible subjects will be randomized in a 1:1 ratio to receive either the control Rd or CRd. Randomization will be stratified by β2 microglobulin levels (\< vs ≥ 2.5 mg/L), prior bortezomib (no vs yes), and prior lenalidomide (no vs yes). Participants will receive the treatment determined by randomization in 28-day cycles until disease progression or unacceptable toxicity (whichever occurs first).

Conditions

• Relapsed Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Dexamethasone	40 mg orally or IV on days 1, 8, 15, 22
DRUG	Lenalidomide	25 mg orally on days 1-21
DRUG	Carfilzomib	20 mg/m², 27 mg/m² intravenously

Timeline

• Start date: 2010-07-14
• Primary completion: 2014-06-16
• Completion: 2017-12-05
• First posted: 2010-03-04
• Last updated: 2022-09-21
• Results posted: 2015-07-08

Locations

127 sites across 20 countries: United States, Austria, Belgium, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Poland, Romania, Russia, Serbia, Spain, Sweden, United Kingdom