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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: BB 1101; Bortezomib; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Immunoglobulin Light Chains

Criteria

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)