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JAMA. 2017 Dec 5;318(21):2099-2110. doi: 10.1001/jama.2017.17924.

Effect of High-Cutoff Hemodialysis vs Conventional Hemodialysis on Hemodialysis Independence Among Patients With Myeloma Cast Nephropathy: A Randomized Clinical Trial.

Author information

1
Department of Nephrology, Institut National de la Santé et de la Recherche Médicale, Centre d'Investigation Clinique 1402, Centre Hospitalier Universitaire, Poitiers, France.
2
Centre de Référence Maladies Rares, Poitiers, France.
3
Centre National de la Recherche Scientifique, Unite Mixte de Recherche 7276, Université de Limoges, Limoges, France.
4
Department of Nephrology, Centre Hospitalier Universitaire, Grenoble, France.
5
Department of Hematology, Centre Hospitalier Universitaire, Grenoble, France.
6
Department of Nephrology, Centre Hospitalier Universitaire, Saint-Etienne, France.
7
Department of Hematology, Centre Hospitalier Universitaire, Saint-Etienne, France.
8
Department of Nephrology, Hôpital Européen Georges Pompidou, Assistance Publique Hôpitaux de Paris, Paris, France.
9
Department of Hematology, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France.
10
Department of Nephrology, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France.
11
Department of Hematology and Immunology, Institut National de la Santé et de la Recherche Médicale, Unité Mixte de Recherche 1126, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France.
12
Department of Nephrology, Centre Hospitalier Universitaire, Rennes, France.
13
Department of Hematology, Centre Hospitalier Universitaire, Rennes, France.
14
Department of Nephrology, Centre Hospitalier Universitaire, Reims, France.
15
Department of Hematology, Centre Hospitalier Universitaire, Reims, France.
16
Department of Hematology, Centre Hospitalier Universitaire, Amiens, France.
17
Department of Nephrology, Centre Hospitalier Universitaire, Tours, France.
18
Department of Hematology, Centre Hospitalier Universitaire, Tours, France.
19
Department of Nephrology, Centre Hospitalier Universitaire, Bordeaux, France.
20
Department of Hematology, Centre Hospitalier Universitaire, Limoges, France.
21
Department of Nephrology, Centre Hospitalier Universitaire, Strasbourg, France.
22
Department of Nephrology, Hôpital Necker, Assistance Publique Hôpitaux de Paris, Paris, France.
23
Department of Biostatistics and Medical Information, Institut National de la Santé et de la Recherche Médicale, Unite Mixte de Recherche 1153 (ECSTRA Team), Paris Diderot University, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France.

Abstract

Importance:

Cast 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.

Objective:

To 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 Participants:

Randomized 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.

Interventions:

Intensive 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 Measures:

Primary 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.

Results:

Among 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 Relevance:

Among 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 Registration:

clinicaltrials.gov Identifier: NCT01208818.

PMID:
29209721
PMCID:
PMC5820717
DOI:
10.1001/jama.2017.17924
[Indexed for MEDLINE]
Free PMC Article

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