Chronic Renal Failure With Uremic Nephropathy Clinical Trial
— MYREOfficial 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.
Verified date | December 2017 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 284 |
Est. completion date | December 2017 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age >=18 years old - Serum creatinine > 170µmol/l and/or DFG < 40 ml/min/1.73 m2 - Myeloma cast nephropathy (MCN) - Multiple myeloma - Informed consent - neutrophils >= 1 Giga/L and platelets >= 70 Giga/L Exclusion Criteria: - Amylosis - Chronic renal Failure with eDFG < 30 ml/min/1.73 m2, unrelated to myeloma - Peripheral neuropathy - Contraindications to either corticosteroids or Bortezomib - Patient refusal - Known HIV infection - Concomitant severe disease including neoplasias (except basocellular carcinoma) - Liver failure, cytolysis, and/or cholestasis - Fertile women who refuse or cannot use effective contraception; Women pregnant or nursing; Women with positive test pregnancy (test before treatment initiation) |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Saint Louis | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
3 months after randomization | |
Secondary | Improvement in renal function | DFG (modified MDRD) hemodialysis requirement |
after 1 cycle of chemotherapy, at the end of chemotherapy, at 6 months and 1 year | |
Secondary | Hematological response | Partial Response (PR) Very Good Partial Response (VGPR) Complete Response (CR) | after 1 and 3 courses, at the end of chemotherapy and at 1 year | |
Secondary | Progression free survival (PFS) | Time to progression, relapse or death from randomization | 4 years | |
Secondary | Time to treatment Failure (TTF) | Time from randomization to progression, relapse, non scheduled hematological treatment or death | 4 years | |
Secondary | Overall survival (OS) | Time to death from randomization | 4 years |