EUropean trial of free LIght chain removal by exTEnded haemodialysis
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 in this setting is cast nephropathy, a direct consequence of high concentrations of monoclonal free light chains (FLCs) in the patient's serum.
FLC removal by extended haemodialysis, using a high cut-off dialyser, has recently been described as a novel therapeutic option in this setting.
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 benefit 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 is a modified PAD regime, consisting of bortezomib, doxorubicin and dexamethasone. FLC removal haemodialysis is undertaken using two Gambro HCO 1100 dialysers in series, over 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 and de novo multiple myeloma.
Trial Registration: ISRCTN45967602
Author: Colin A Hutchison, Mark Cook, Nils Heyne, Kataja Weisel, Lucinda Billingham, Arthur R Bradwell and Paul Cockwell
FLC removal by extended haemodialysis, using a high cut-off dialyser, has recently been described as a novel therapeutic option in this setting.
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 benefit 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 is a modified PAD regime, consisting of bortezomib, doxorubicin and dexamethasone. FLC removal haemodialysis is undertaken using two Gambro HCO 1100 dialysers in series, over 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 and de novo multiple myeloma.
Trial Registration: ISRCTN45967602
Author: Colin A Hutchison, Mark Cook, Nils Heyne, Kataja Weisel, Lucinda Billingham, Arthur R Bradwell and Paul Cockwell
posted by gwg at 12:39 PM
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