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Participants will receive FLC removal HD undertaken using an extended dialysis schedule on the Gambro HCO 1100 dialysers

Patients receive standard dialysis on a high flux ployflux dialyser at a frequency determined by the duty nephrologist

FLC removal HD using a extended dialysis schedule on the Gambro HCO 1100

FLC removal HD (Gambro HCO 1100)

Standard dialysis on a high flux ployflux dialyser at a frequency determined by the duty nephrologist

Standard dialysis on a high flux ployflux dialyser

Paul Cockwell, PhD FRCP

Mark Cook, PhD FRCPath

Hypothesis: Free light chain removal haemodialysis will increase the rate of renal recovery in patients with cast nephropathy, severe renal failure and de novo multiple myeloma.

This study will randomise patients with multiple myeloma and severe renal failure to treatment to remove free light chains by haemodialysis or not.

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.

European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy

Gambro Renal Products, Inc.

Ortho Biotech, Inc.

University Hospital Birmingham

Doctor Paul Cockwell

Acute Kidney Injury

Acute Graft Versus Host Disease

Participants will receive FLC removal HD undertaken using an extended dialysis schedule on KIDNEY therapy system. Treatments (4 hours each) were carried out for 8 consecutive days and then every other day.

KIDNEY therapy

Sonia Pasquali, MD

Francesco Iannuzzella, MD

Hypothesis: Free light chain (FLC) removal haemodialysis will increase the rate of renal recovery in patients with cast nephropathy, severe renal failure and de novo multiple myeloma.

This study will evaluate patients with multiple myeloma and severe renal failure treated with KIDNEY Therapy (previously called SUPRA HFR) to remove free light chains.

This is an observational study performed to investigate the clinical benefit of FLC removal by KIDNEY therapy system in patients with cast nephropathy, dialysis dependent renal failure and de novo multiple myeloma. Recruitment commenced in July 2014, in total 20 patients will be recruited. Participants will be treated with, KIDNEY therapy system (Bellco Mirandola, Modena, Italy) . The KIDNEY system is a kind of haemodiafiltration that utilizes separated convection, diffusion and adsorption. The sorbent cartridge has a high affinity for FLC (both κ and λ) but is able to re-infuse albumin, avoiding the need for albumin perfusions. The KIDNEY therapy will be undertaken over an intensive treatment schedule. The primary outcome for the study is independence of dialysis in 3 month. Secondary outcomes are: duration dialysis, reduction of serum FLC levels, myeloma response and survival.

Kidney Therapy for Free Light Chain Removal in Patients With Multiple Myeloma & Cast Nephropathy

KIDNEY THERAPY FOR FREE LIGHT CHAIN REMOVAL IN PATIENTS WITH MULTIPLE MYELOMA & CAST NEPHROPATHY

Arcispedale Santa Maria Nuova-IRCCS

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy	NCT00700531	Multiple Myelom... Cast Nephropath... Kidney Failure	FLC removal HD ... Standard dialys...	18 Years -	University Hospital Birmingham
Kidney Therapy for Free Light Chain Removal in Patients With Multiple Myeloma & Cast Nephropathy	NCT02358980	Multiple Myelom... Cast Nephropath... Acute Kidney In...	KIDNEY therapy	18 Years -	Arcispedale Santa Maria Nuova-IRCCS
Kidney Therapy for Free Light Chain Removal in Patients With Multiple Myeloma & Cast Nephropathy	NCT02358980	Multiple Myelom... Cast Nephropath... Acute Kidney In...	KIDNEY therapy	18 Years -	Arcispedale Santa Maria Nuova-IRCCS

Spots Global Cancer Trial Database for cast nephropathy