Clinical trial · Interventional
Studies in Patients With Multiple Myeloma and Renal Failure Due to Myeloma Cast Nephropathy
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Renal Failure With Uremic Nephropathy | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib +Dexamethasone regimen | Drug | — | UNRESOLVED |
| conventional high-flux dialyzer | Device | — | UNRESOLVED |
| Cyclophosphamide + Bortezomib + Dexamethasone regimen | Drug | — | UNRESOLVED |
| HCO group | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- BD
- interventionNames
- Drug: Bortezomib +Dexamethasone regimen
- type
- EXPERIMENTAL
- label
- C-BD
- interventionNames
- Drug: Cyclophosphamide + Bortezomib + Dexamethasone regimen
- type
- EXPERIMENTAL
- label
- HCO
- interventionNames
- Drug: Bortezomib +Dexamethasone regimen
- Device: HCO group
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDBridoux F, Carron PL, Pegourie B, Alamartine E, Augeul-Meunier K, Karras A, Joly B, Peraldi MN, Arnulf B, Vigneau C, Lamy T, Wynckel A, Kolb B, Royer B, Rabot N, Benboubker L, Combe C, Jaccard A, Moulin B, Knebelmann B, Chevret S, Fermand JP; MYRE Study Group. Effect of High-Cutoff Hemodialysis vs Conventional Hemodialysis on Hemodialysis Independence Among Patients With Myeloma Cast Nephropathy: A Randomized Clinical Trial. JAMA. 2017 Dec 5;318(21):2099-2110. doi: 10.1001/jama.2017.17924. PMID 29209721