Hutchison CA, Cook M, Heyne N, Weisel K, Billingham L, Bradwell A, Cockwell P. European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): A randomised control trial. Trials. 2008 Sep 28;9:55.
Figure. The Gambro HCO 1100 (a high cut-off protein permeable membrane which offers significantly higher permeability for substances in the molecular weight range 15 to 45 kDa) as used in ICU, Pamela Youde Nethersole Eastern Hospital, Hong Kong
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.
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References
1. Gambro launches HCO 1100 – a new membrane technology with the potential to advance the treatment of multiple myeloma patients with acute renal failure (press release on 27 August 2007 here)
2. Gambro HCO 1100 information here
3. Hutchison CA, Harding S, Mead G, Goehl H, Storr M, Bradwell A, Cockwell P.Serum free-light chain removal by high cutoff hemodialysis: optimizing removal and supportive care. Artif Organs. 2008 Dec;32(12):910-7.
4. C.A. Hutchison, A.R. Bradwell, G. Mead, K. Chandler, J. Harper, M. Cook, M. Storr, H. Goehl, P. Cockwell. Free Light Chain Removal by Extended Hemodialysis in Patients with Cast Nephropathy from Multiple Myeloma. J Am Soc Nephrol November / Vol. 17/ 23A; TH-FC102, 2006
5. C.A. Hutchison, P. Cockwell, S. Reis, K. Chandler, G.P. Mead, J. Harrison, J. Hattersley, N.D. Evans, M.J. Chapell, M. Cook, H. Goehl, M. Storr, A.R. Bradwell. Efficient removal of immunoglobulin free light chains by hemodialysis for Multiple Myeloma: In vitro and in vivo studies. J Am Soc Nephrol March / Vol. 18 / No. 3 : 886-895, 2007
6. C.A. Hutchison, P. Cockwell, K. Basnayake, M. Cook, S. Harding, S. Basu, G. Mead, A.R. Bradwell. Removal of Free Light Chains by Extended Hemodialysis in Patients with Cast Nephropathy a Phase ½ Clinical Trial. Nephrol Dial Transplant 22 Suppl 6: vi58; FP122, 2007
7. N. Heyne, K.C. Weisel, C.A. Hutchison, B. Friedrich, H. Goehl, L. Kanz, T. Risler. Characterization of extra corporal Serum Free Light Chain Elimination Kinetics via High Cut-Off Protein Permeable Membrane in Light Chain Multiple Myeloma. Nephrol Dial Transplant 22 Suppl 6: vi123; FP315, 2007