European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy (EuLITE)
Primary Purpose
Multiple Myeloma, Cast Nephropathy, Kidney Failure
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
FLC removal HD (Gambro HCO 1100)
Standard dialysis on a high flux ployflux dialyser
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Hemodialysis, Multiple myeloma, Cast nephropathy, Kidney failure
Eligibility 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
Sites / Locations
- University Hospital Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
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
Outcomes
Primary Outcome Measures
Independence of haemodialysis at 3 months from enrollment (eGFR > 15mls/min/1.73m2 at 2 weeks after last dialysis session)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00700531
First Posted
June 13, 2008
Last Updated
October 4, 2016
Sponsor
University Hospital Birmingham
Collaborators
Gambro Renal Products, Inc., Ortho Biotech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00700531
Brief Title
European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy
Acronym
EuLITE
Official Title
European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Birmingham
Collaborators
Gambro Renal Products, Inc., Ortho Biotech, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Cast Nephropathy, Kidney Failure
Keywords
Hemodialysis, Multiple myeloma, Cast nephropathy, Kidney failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive FLC removal HD undertaken using an extended dialysis schedule on the Gambro HCO 1100 dialysers
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients receive standard dialysis on a high flux ployflux dialyser at a frequency determined by the duty nephrologist
Intervention Type
Device
Intervention Name(s)
FLC removal HD (Gambro HCO 1100)
Other Intervention Name(s)
Gambro HCO 1100
Intervention Description
FLC removal HD using a extended dialysis schedule on the Gambro HCO 1100
Intervention Type
Procedure
Intervention Name(s)
Standard dialysis on a high flux ployflux dialyser
Intervention Description
Standard dialysis on a high flux ployflux dialyser at a frequency determined by the duty nephrologist
Primary Outcome Measure Information:
Title
Independence of haemodialysis at 3 months from enrollment (eGFR > 15mls/min/1.73m2 at 2 weeks after last dialysis session)
Time Frame
3 months from enrollment
Secondary Outcome Measure Information:
Title
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
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Cockwell, PhD FRCP
Organizational Affiliation
University Hospital Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Cook, PhD FRCPath
Organizational Affiliation
University Hospital Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Birmingham
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2GW
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Under consideration
Citations:
PubMed Identifier
17229909
Citation
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.
Results Reference
background
PubMed Identifier
19133018
Citation
Hutchison 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.
Results Reference
background
PubMed Identifier
18822172
Citation
Hutchison 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.
Results Reference
background
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European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy
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