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:

To compare progression-free survival in subjects with relapsed multiple myeloma who are receiving CRd vs subjects receiving Rd in a randomized multicentre setting.

Trial Description

Primary Outcome:

  • Progression-free Survival (PFS)
Secondary Outcome:
  • Overall Survival
  • Overall Response
  • Disease Control
  • Duration of Response
  • Duration of Disease Control
  • QLQ-C30 Global Health Status/Quality of Life Scores
This is a Phase 3, randomized, open-label, multicentre study comparing two treatment regimens for subjects 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). Subjects will receive the treatment determined by randomization in 28-day cycles until disease progression or unacceptable toxicity (whichever occurs first). The primary endpoint of this Phase 3 study is progression-free survival.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society