Status:
COMPLETED
European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy
Lead Sponsor:
University Hospital Birmingham
Collaborating Sponsors:
Gambro Renal Products, Inc.
Ortho Biotech, Inc.
Conditions:
Multiple Myeloma
Cast Nephropathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 rando...
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 clin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00700531
Start Date
June 1 2008
End Date
October 1 2015
Last Update
October 5 2016
Active Locations (1)
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1
University Hospital Birmingham
Birmingham, West Midlands, United Kingdom, B15 2GW