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

Official Title

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

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 multicentre setting.

Trial Description

Primary Outcome:

• Progression-free Survival (PFS)

Secondary Outcome:

• Overall Survival
• Overall Response Rate
• Disease Control Rate
• Duration of Response
• Duration of Disease Control
• Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores

This is a Phase 3, randomized, open-label, multicentre 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).

View this trial on ClinicalTrials.gov