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Published in: Trials 1/2008

Open Access 01-12-2008 | Study protocol

European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): A randomised control trial

Authors: Colin A Hutchison, Mark Cook, Nils Heyne, Katja Weisel, Lucinda Billingham, Arthur Bradwell, Paul Cockwell

Published in: Trials | Issue 1/2008

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Abstract

Background

Renal failure is a frequent complication of multiple myeloma and when severe is associated with a greatly increased morbidity and mortality. The principal cause of severe renal failure is cast nephropathy, a direct consequence of high concentrations of monoclonal free light chains (FLCs) in patients' sera. FLC removal by extended haemodialysis, using a high cut-off dialyser, has recently been described as a novel therapeutic option.

Methods

The EU ropean trial of free LI ght chain removal by exTE nded haemodialysis in cast nephropathy (EuLITE) trial is a prospective, randomised, multicentre, open label clinical trial to investigate the clinical benefits of FLC removal haemodialysis in patients with cast nephropathy, dialysis dependent acute renal failure and de novo multiple myeloma. Recruitment commenced in May 2008. In total, 90 patients will be recruited. Participants will be randomised, centrally, upon enrolment, to either trial chemotherapy and FLC removal haemodialysis or trial chemotherapy and standard high flux haemodialysis. Trial chemotherapy consists of bortezomib, doxorubicin and dexamethasone. FLC removal haemodialysis is undertaken with two Gambro HCO 1100 dialysers in series using an intensive treatment schedule. The primary outcome for the study is independence of dialysis at 3 months. Secondary outcomes are: duration of dialysis, reduction in serum FLC concentrations; myeloma response and survival.

Hypothesis

FLC removal haemodialysis will increase the rate of renal recovery in patients with severe renal failure secondary to cast nephropathy in de novo multiple myeloma.

Trial registration

ISRCTN45967602
Appendix
Available only for authorised users
Literature
1.
Alexanian R, Barlogie B, Dixon D: Renal failure in multiple myeloma. Pathogenesis and prognostic implications. Arch Intern Med. 1990, 150: 1693-1695. 10.1001/archinte.150.8.1693.CrossRefPubMed
2.
Blade J, Fernandez-Llama P, Bosch F, Montoliu J, Lens XM, Montoto S, Cases A, Darnell A, Rozman C, Montserrat E: Renal failure in multiple myeloma: presenting features and predictors of outcome in 94 patients from a single institution. Arch Intern Med. 1998, 158: 1889-1893. 10.1001/archinte.158.17.1889.CrossRefPubMed
3.
Rayner HC, Haynes AP, Thompson JR, Russell N, Fletcher J: Perspectives in multiple myeloma: survival, prognostic factors and disease complications in a single centre between 1975 and 1988. Quart J Med. 1991, 79: 517-525.PubMed
4.
Sakhuja V, Jha V, Varma S, Joshi K, Gupta KL, Sud K, Kohli HS: Renal involvement in multiple myeloma: a 10-year study. Renal Failure. 2000, 22: 465-477. 10.1081/JDI-100100888.CrossRefPubMed
5.
Leung N, Gertz MA, Zeldenrust SR, Rajkumar SV, Dispensenzieri A, Fervenza FC, Kumar S, Lacy MQ, Lust JA, Greipp PR, Witzig TE, Hayman SR, Russel SJ, Kyle RA, Winters JL: Improvement of cast nephropathy with plasma exchange depends on the diagnosis and on reduction of serum free light chains. Kidney Int. 2008, 73 (11): 1282-8. 10.1038/ki.2008.108.CrossRefPubMed
6.
Hutchison CA, Basnayake K, Cook M, Bradwell AR, Cockwell P: Free Light Chain Hemodialysis Increases Renal Recovery Rate and Improves Patient Survival in Patients with Cast Nephropathy. Nephrol Dial Transplant Plus. 2008, 1 (Suppl 2): ii9a-
7.
Sanders PW: Pathogenesis and treatment of myeloma kidney. J Lab Clin Med. 1994, 124 (4): 484-8.PubMed
8.
Chanan-Khan AA, Kaufman JL, Mehta J, Richardson PG, Miller KC, Lonial S, Munshi NC, Schlossman R, Tariman J, Singhal S: Activity and safety of bortezomib in multiple myeloma patients with advanced renal failure: a multicenter retrospective study. Blood. 2007, 109 (6): 2604-6. 10.1182/blood-2006-09-046409.CrossRefPubMed
9.
Ludwig H, Drach J, Graf H, Lang A, Meran JG: Reversal of acute renal failure by bortezomib-based chemotherapy in patients with multiple myeloma. Haematologica. 2007, 92 (10): 1411-1414. 10.3324/haematol.11463.CrossRefPubMed
10.
Kastritis E, Anagnostopoulos A, Roussou M, Gikka D, Matsouka C, Barmparousi D, Grapsa I, Psimenou E, Barmias A, Dimopoulos MA: Reversibility of renal failure in newly diagnosed multiple myeloma patients treated with high dose dexamethasone-containing regimes and the impact of novel agents. Haematologica. 2007, 92: 546-549. 10.3324/haematol.10759.CrossRefPubMed
11.
Clark WF, Stewart AK, Rock GA, Sternbach M, Sutton DM, Barrett BJ, Heidenheim AP, Garg AX, Churchill DN, Canadian Apheresis Group: Plasma exchange when myeloma presents as acute renal failure: a randomized, controlled trial. Ann Intern Med. 2005, 143 (11): 777-784.CrossRefPubMed
12.
Ritz E: Plasma exchange for acute renal failure of Myeloma – Logical, yet ineffective. J Am Soc Nephrol. 2006, 17: 914-916. 10.1681/ASN.2006080919.CrossRef
13.
Clark WF, Garg AX: Plasma exchange for myeloma kidney: cast (s) away?. Kidney Int. 2008, 73: 1211-1213. 10.1038/ki.2008.117.CrossRefPubMed
14.
Hutchison CA, Cockwell P, Reid S, Chandler K, Mead GP, Harrison J, Hattersley J, Evans ND, Chappel MJ, Cook M, Goehl H, Storr M, Bradwell AR: Efficient Removal of Immunoglobulin Free Light Chains by Hemodialysis for Multiple Myeloma: In-vitro and in-vivo studies. J Am Soc Nephrol. 2007, 18: 886-895. 10.1681/ASN.2006080821.CrossRefPubMed
15.
Bachmann U, Schindler R, Storr M, Kahl A, Joerres A, Sturm I: Combination of bortezomib-based cheometherapy and extracorpeal free light chain removal for treating cast nephropathy in multiple myeloma. Nephrol Dial Transplant Plus. 2008, 1: 106-108.
16.
International Myeloma Working Group: Criteria for the classification of monoclonal gammopathies, multiple myeloma and related disorders: a report of the International Myeloma Working Group. British Journal of Haematology. 2003, 121: 749-757. 10.1046/j.1365-2141.2003.04355.x.CrossRef
17.
Pocock SJ, Simon R: Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trials. Biometrics. 1975, 31: 103-115. 10.2307/2529712.CrossRefPubMed
18.
Oakervee HE, Popat R, Curry N, Smith P, Morris C, Drake M, Agrawal S, Stec J, Schenkein D, Esseltine DL, Cavenagh JD: PAD combination therapy (PS-341/bortezomib, doxorubicin and dexamethasone) for previously untreated patients with multiple myeloma). British J Haem. 2005, 129: 755-762. 10.1111/j.1365-2141.2005.05519.x.CrossRef
19.
Durie BG, Harousseau JL, Miguel JS: International uniform response criteria for multiple myeloma. Leukemia. 2006, 20: 1467-1473. 10.1038/sj.leu.2404284.CrossRefPubMed
Metadata
Title
European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): A randomised control trial
Authors
Colin A Hutchison
Mark Cook
Nils Heyne
Katja Weisel
Lucinda Billingham
Arthur Bradwell
Paul Cockwell
Publication date
01-12-2008
Publisher
BioMed Central
Published in
Trials / Issue 1/2008
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-9-55

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