European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy
Conditions
Multiple Myeloma - Cast Nephropathy - Kidney Failure
Conditions: official terms
Kidney Diseases - Multiple Myeloma - Neoplasms, Plasma Cell - Renal Insufficiency
Conditions: Keywords
Hemodialysis, Multiple myeloma, Cast nephropathy, Kidney failure
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: FLC removal HD (Gambro HCO 1100) Type: Device
Name: Standard dialysis on a high flux ployflux dialyser Type: Procedure
Overall Status
Recruiting
Summary
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.
Detailed 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
University Hospital Birmingham
Birmingham, West Midlands, United Kingdom
Status: Recruiting
Contact: Colin Hutchison, MBChB - 447723917870 - c.a.hutchison@bham.ac.uk
Start Date
June 2008
Completion Date
June 2012
Sponsors
University Hospital Birmingham
Source
University Hospital Birmingham
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page