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Trials. 2008 Sep 28;9:55. doi: 10.1186/1745-6215-9-55.

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

Trials

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

Affiliations

  1. Department of Nephrology, University Hospital Birmingham, Birmingham, UK. [email protected]

PMID: 18822172 PMCID: PMC2564897 DOI: 10.1186/1745-6215-9-55

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 EUropean trial of free LIght chain removal by exTEnded 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.

References

  1. Ren Fail. 2000;22(4):465-77 - PubMed
  2. Biometrics. 1975 Mar;31(1):103-15 - PubMed
  3. Br J Haematol. 2003 Jun;121(5):749-57 - PubMed
  4. Br J Haematol. 2005 Jun;129(6):755-62 - PubMed
  5. Ann Intern Med. 2005 Dec 6;143(11):777-84 - PubMed
  6. Leukemia. 2006 Sep;20(9):1467-73 - PubMed
  7. Blood. 2007 Mar 15;109(6):2604-6 - PubMed
  8. J Am Soc Nephrol. 2007 Mar;18(3):886-95 - PubMed
  9. Haematologica. 2007 Apr;92(4):546-9 - PubMed
  10. Haematologica. 2007 Oct;92(10):1411-4 - PubMed
  11. Kidney Int. 2008 Jun;73(11):1282-8 - PubMed
  12. Kidney Int. 2008 Jun;73(11):1211-3 - PubMed
  13. Q J Med. 1991 Jun;79(290):517-25 - PubMed
  14. Arch Intern Med. 1990 Aug;150(8):1693-5 - PubMed
  15. NDT Plus. 2008 Apr;1(2):106-108 - PubMed
  16. J Lab Clin Med. 1994 Oct;124(4):484-8 - PubMed
  17. Arch Intern Med. 1998 Sep 28;158(17):1889-93 - PubMed

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