European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy
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 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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Independence of haemodialysis at 3 months from enrollment (eGFR > 15mls/min/1.73m2 at 2 weeks after last dialysis session)
3 months from enrollment
No
Paul Cockwell, MBChB
Principal Investigator
University Hospital Birmingham
United Kingdom: Medicines and Healthcare Products Regulatory Agency
EudraCT 2007-003968-22
NCT00700531
June 2008
June 2012
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