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

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.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.ISRCTN45967602Renal impairment is a frequent complication of multiple myeloma affecting between 18 and 56% of patients at presentation [1-4]. When severe it is associated with a greatly increased morbidity and mortality. However, improvement of renal function also improves the patients' survival [2,5,6]. Previous studies have demonstrated that the principal cause of severe renal failure in patients with multiple myeloma is cast nephropathy, a direct consequence of the high concentrations of monoclonal free light chains (FLCs) in the patients' sera.Treatment strategies for patients with severe renal failure and multiple myeloma should first focus on correcting reversible factors such as dehydration and hypercalcaemia [7]. Second, disease specific treatments should be initiated rapidly and there is growing evidence for the role of new ch