Chronic Renal Failure With Uremic Nephropathy Clinical Trial
Official title:
Treatment of Renal Failure Due to Myeloma Cast Nephropathy: Comparison of Two Different Chemotherapy Regimens and Evaluation of Optimized Removal of Monoclonal Immunoglobulin Light Chains Using a High Permeability Hemodialysis Membrane.
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.
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.
Study hypotheses are: (1) in patients not requiring dialysis, based on renal response after 3
cycles as the main endpoint, to show a benefit of 30% in absolute rate from an expected 30%
response rate in the control arm; and (2) in patients requiring hemodialysis, using the
prevalence of patients free of dialysis after 3 cycles as the main endpoint, to show a
benefit of at least 20% from an assumed rate of 50% in the control arm. A total sample size
of 284 patients was computed to be enrolled (type I and II error rates at 5 and 20%,
respectively).
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