European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy
EuLITE
2 other identifiers
interventional
90
1 country
1
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 randomise patients with multiple myeloma and severe renal failure to treatment to remove free light chains by haemodialysis or not.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable multiple-myeloma
Started Jun 2008
Longer than P75 for not_applicable multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 13, 2008
CompletedFirst Posted
Study publicly available on registry
June 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedOctober 5, 2016
October 1, 2016
5.6 years
June 13, 2008
October 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Independence of haemodialysis at 3 months from enrollment (eGFR > 15mls/min/1.73m2 at 2 weeks after last dialysis session)
3 months from enrollment
Secondary Outcomes (1)
Efficiency of extended HD with respect to reduced sFLC concentrations; duration of HD before renal recovery; multiple myeloma response to chemotherapy and suitability for stem cell transplantation; mortality over 24 months observation period
24 months
Study Arms (2)
1
EXPERIMENTALParticipants will receive FLC removal HD undertaken using an extended dialysis schedule on the Gambro HCO 1100 dialysers
2
ACTIVE COMPARATORPatients receive standard dialysis on a high flux ployflux dialyser at a frequency determined by the duty nephrologist
Interventions
FLC removal HD using a extended dialysis schedule on the Gambro HCO 1100
Standard dialysis on a high flux ployflux dialyser at a frequency determined by the duty nephrologist
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Birminghamlead
- Gambro Renal Products, Inc.collaborator
- Ortho Biotech, Inc.collaborator
Study Sites (1)
University Hospital Birmingham
Birmingham, West Midlands, B15 2GW, United Kingdom
Related Publications (3)
Hutchison CA, Cockwell P, Reid S, Chandler K, Mead GP, Harrison J, Hattersley J, Evans ND, Chappell MJ, Cook M, Goehl H, Storr M, Bradwell AR. Efficient removal of immunoglobulin free light chains by hemodialysis for multiple myeloma: in vitro and in vivo studies. J Am Soc Nephrol. 2007 Mar;18(3):886-95. doi: 10.1681/ASN.2006080821. Epub 2007 Jan 17.
PMID: 17229909BACKGROUNDHutchison CA, Harding S, Mead G, Goehl H, Storr M, Bradwell A, Cockwell P. Serum free-light chain removal by high cutoff hemodialysis: optimizing removal and supportive care. Artif Organs. 2008 Dec;32(12):910-7. doi: 10.1111/j.1525-1594.2008.00653.x.
PMID: 19133018BACKGROUNDHutchison CA, Cook M, Heyne N, Weisel K, Billingham L, Bradwell A, Cockwell P. European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): a randomised control trial. Trials. 2008 Sep 28;9:55. doi: 10.1186/1745-6215-9-55.
PMID: 18822172BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Cockwell, PhD FRCP
University Hospital Birmingham
- PRINCIPAL INVESTIGATOR
Mark Cook, PhD FRCPath
University Hospital Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor Paul Cockwell
Study Record Dates
First Submitted
June 13, 2008
First Posted
June 18, 2008
Study Start
June 1, 2008
Primary Completion
January 1, 2014
Study Completion
October 1, 2015
Last Updated
October 5, 2016
Record last verified: 2016-10