European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy (EuLITE): a Randomised Control Trial

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2008 Sep 30

PMID 18822172

Citations 25

Authors

Colin A Hutchison

Mark Cook

Nils Heyne

Katja Weisel

Lucinda Billingham

Arthur Bradwell

Paul Cockwell

Affiliations

Soon will be listed here.

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.

Citing Articles

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Successful renal recovery from multiple myeloma-associated crystalline light chain cast nephropathy and accompanying acute kidney injury with early use of bortezomib-based therapy: a case report and literature review.

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