A Phase 3 interventional study of Cyclophosphamide + Bortezomib + Dexamethasone regimen and Bortezomib +Dexamethasone regimen in Chronic Renal Failure With Uremic Nephropathy, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-08.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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).
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 284 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Exclusion Criteria:
Drug: Bortezomib +Dexamethasone regimen
Drug: Cyclophosphamide + Bortezomib + Dexamethasone regimen
Drug: Bortezomib +Dexamethasone regimen · Device: HCO group
Drug: Bortezomib +Dexamethasone regimen · Device: conventional high-flux dialyzer
Dosing regimen (21 day-cycle): * Bortezomib 1.3 mg/m2 I.V. on days 1, 4, 8, and 11. An interval of at least 72 hours between each administration of bortezomib is required. * Dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12. * Cyclophosphamide 900 mg/m2 on day 1, through a short I.V. infusion The regimen is given for 3 cycles in the absence of serious side-effect.
Dosing regimen (21 day-cycle): * Bortezomib 1.3 mg/m2 I.V. on days 1, 4, 8, and 11. An interval of at least 72 hours between each administration of bortezomib is required. * Dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12. The regimen is given for 3 cycles in the absence of serious side-effect.
TheraliteTM dialyzer of 2.1 m2 in surface
conventional high-flux dialyzer; polyacrylonitrile, polysulfone, or PMMA dialysers, with an ultrafiltration coefficient \> 14 ml/min and ≥ 1.8 m2 in surface, are recommended.
Prevalence of renal response (if dialysis not mandatory at baseline: strata 1); Prevalence of patients free of dialysis (if dialysis required at baseline; strata 2)
* renal response is defined by creatinine≤ 170 µmol/l and/or DFG (modified MDRD) ≥ 40 ml/min/1.73m2 * the absence of any dialysis requirement will be defined by an eDFG \> 15 ml/min/1.73 m2, 15 days after the last hemodialysis session
Time frame: 3 months after randomization
Improvement in renal function
* DFG (modified MDRD) * hemodialysis requirement
Time frame: after 1 cycle of chemotherapy, at the end of chemotherapy, at 6 months and 1 year
Hematological response
Partial Response (PR) Very Good Partial Response (VGPR) Complete Response (CR)
Time frame: after 1 and 3 courses, at the end of chemotherapy and at 1 year
Progression free survival (PFS)
Time to progression, relapse or death from randomization
Time frame: 4 years
Time to treatment Failure (TTF)
Time from randomization to progression, relapse, non scheduled hematological treatment or death
Time frame: 4 years
Overall survival (OS)
Time to death from randomization
Time frame: 4 years
Plan to share: Undecided
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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