drugset / Trial / NCT01208818

Studies in Patients With Multiple Myeloma and Renal Failure Due to Myeloma Cast Nephropathy

NCT01208818

Phase 3 Completed 284 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupOpen-labelTreatment

Summary

MYRE is a phase III multicentric controlled national clinical trial conducted in patients with multiple myeloma and renal failure related to myeloma cast nephropathy (MCN). Its aims are to assess (1) the efficacy of bortezomib plus dexamethasone (BD), compared with cyclophosphamide, plus bortezomib and dexamethasone (C-BD) in patients with inaugural MCN not requiring hemodialysis; and (2) in patients with inaugural severe renal failure secondary to biopsy-proven MCN and requiring hemodialysis that of an intensive hemodialysis regimen using either a dialyser with very high permeability to proteins (TheraliteTM) or a conventional high-flux dialyser, while receiving chemotherapy with BD.

Timeline

Start
2011-06
Primary completion
2015-09
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 900 mg/m2 Intravenous
Background Bortezomib Small molecule 1.3 mg/m2 Intravenous
Background Dexamethasone Small molecule 20 mg