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

University Hospitals Birmingham NHS Foundation Trust (UHB)

Status

Completed

Conditions

Kidney Failure

Multiple Myeloma

Cast Nephropathy

Treatments

Procedure: Standard dialysis on a high flux ployflux dialyser

Device: FLC removal HD (Gambro HCO 1100)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00700531

ISRCTN45967602

EudraCT 2007-003968-22

Details and patient eligibility

About

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.

Full description

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.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age >= 18 years
Dialysis dependent acute renal failure (eGFR <15ml/min/1.73m2)
Fulfils diagnostic criteria for the diagnosis of symptomatic de novo multiple myeloma1
Abnormal serum FLC ratio and a sFLC concentration > 500 mg/L
Myeloma kidney demonstrated on a renal biopsy (cast nephropathy)
Ability to give informed consent to partake in study
Commencement of study within 10 days of presenting to enrolling unit

Exclusion criteria

Age < 18 years
Known advanced chronic renal failure (CKD stage IV 4-5; eGFR <30mls/min/1.73m2) or evidence of significant chronic damage on renal biopsy
Amyloidosis or light chain deposition disease on renal biopsy
Previous treatment of multiple myeloma with chemotherapy
Haemodynamic instability that precludes unsupported dialysis renal replacement therapy
Significant cardiac disease (myocardial infarction with in the last 6 months; unstable angina; NYHA class III or IV heart failure; clinically significant pericardial disease; cardiac amyloidosis)
Advanced disease or significant co-morbidity: with poor short term prognosis, necessitating palliation and no active or disease specific treatment.
Inability to give informed consent
History of allergic reaction attributable to compounds containing boron or mannitol
History of Peripheral neuropathy or neuropathic pain (grade 2 or higher as defined by NCI CTCAE version 3)
Clinically significant liver dysfunction (bilirubin >1.8mg/dl (30µmol/L))
Known HIV infection
Active uncontrolled infection
Pregnant and lactating women
Inability to give informed consent
Pre-menopausal female patients of childbearing potential: positive pregnancy test or unwilling to use effective contraception during the study
Lactation