• Frank Bridoux, Pierre-Louis Carron, Brigitte Pegourie, Eric Alamartine, Karine Augeul-Meunier, Alexandre Karras, Bertrand Joly, Marie-Noëlle Peraldi, Bertrand Arnulf, Cécile Vigneau, Thierry Lamy, Alain Wynckel, Brigitte Kolb, Bruno Royer, Nolwenn Rabot, Lotfi Benboubker, Christian Combe, Arnaud Jaccard, Bruno Moulin, Bertrand Knebelmann, Sylvie Chevret, Jean-Paul Fermand, and MYRE Study Group.
• Department of Nephrology, Institut National de la Santé et de la Recherche Médicale, Centre d'Investigation Clinique 1402, Centre Hospitalier Universitaire, Poitiers, France.
• JAMA. 2017 Dec 5; 318 (21): 209921102099-2110.

ImportanceCast nephropathy is the main cause of acute kidney injury in multiple myeloma and persistent reduction in kidney function strongly affects prognosis. Strategies to rapidly remove nephrotoxic serum-free light chains combined with novel antimyeloma agents have not been evaluated prospectively.ObjectiveTo compare the hemodialysis independence rate among patients newly diagnosed with myeloma cast nephropathy treated with hemodialysis using a high-cutoff dialyzer (with very large membrane pores and high permeability to immunoglobulin light chains) or a conventional high-flux dialyzer (with small pores and lower permeability).Design, Setting, And ParticipantsRandomized clinical trial involving 98 patients with biopsy-proven myeloma cast nephropathy requiring hemodialysis treated at 48 French centers between July 2011 and June 2016; the final date of follow-up was June 29, 2016.InterventionsIntensive hemodialysis (eight 5-hour sessions over 10 days) with either a high-cutoff dialyzer (46 patients) or a conventional high-flux dialyzer (48 patients). All patients received the same chemotherapy regimen of bortezomib and dexamethasone.Main Outcomes And MeasuresPrimary end point was hemodialysis independence at 3 months; secondary end points: hemodialysis independence rates at 6 and 12 months, hemodialysis- and chemotherapy-related adverse events, and death.ResultsAmong 98 randomized patients, 94 (96%) (median age, 68.8 years [interquartile range, 61.2-75.3 years]; 45% women) were included in the modified intent-to-treat analysis. The hemodialysis independence rate at 3 months was 41.3% (n = 19) in the high-cutoff hemodialysis group vs 33.3% (n = 16) in the conventional hemodialysis group (between-group difference, 8.0% [95% CI, -12.0% to 27.9%], P = .42); at 6 months, the rate was 56.5% (n = 26) vs 35.4% (n = 17), respectively (between-group difference, 21.1% [95% CI, 0.9% to 41.3%], P = .04); and at 12 months, the rate was 60.9% (n = 28) vs 37.5% (n = 18) (between-group difference, 23.4% [95% CI, 3.2% to 43.5%], P = .02). The incidence of hemodialysis-related adverse events was 43% in the high-cutoff hemodialysis group vs 39% in the conventional hemodialysis group; chemotherapy-related serious adverse events, 39% vs 37%, respectively; and at 12 months, 9 patients vs 10 patients died.Conclusions And RelevanceAmong patients with myeloma cast nephropathy treated with a bortezomib-based chemotherapy regimen, the use of high-cutoff hemodialysis compared with conventional hemodialysis did not result in a statistically significant difference in hemodialysis independence at 3 months. However, the study may have been underpowered to identify an early clinically important difference.Trial Registrationclinicaltrials.gov Identifier: NCT01208818.

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