Contact information
Type
Scientific
Primary contact
Dr Colin Hutchison
ORCID ID
Contact details
Queen Elizabeth Medical Centre
Birmingham
B15 2TH
United Kingdom
+44 (0)121 472 1311
c.a.hutchison@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00700531
Protocol/serial number
1.0
Study information
Scientific title
European trial of free light chain removal by extended haemodialysis in cast nephropathy
Acronym
EuLITE
Study hypothesis
Free light removal by extended haemodialysis aids recovery of renal function in patients with cast nephropathy.
On 29/01/10 Denmark was added and Italy and Poland removed from the countries of recruitment. The overall trial end date was extended from 01/09/09 to 01/01/2012.
On 12/04/2011 the overall trial end date for this trial was extended from 01/01/2012 to 31/12/2014. Denmark was removed from the countries of recruitment.
Ethics approval
Central Office for Research Ethics Committees (COREC), 04/02/2008, ref: 07/H1307/133
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Multiple myeloma, acute renal failure and cast nephropathy
Intervention
All patients will receive standardised chemotherapy (velcade based regime). At enrolment the patients are randomised to receive either standard dialysis or free light chain (FLC) removal haemodialysis. FLC removal HD is undertaken using the Gambro HCO 1100 dialyser. Dialysis sessions are longer (8 hours versus 4 hours) and more frequent than the conventional dialysis received by the control arm. Standard dialysis (control arm) is that used for the management of patients with acute renal failure 4 hours, three times per week.
Intervention type
Drug
Phase
Not Applicable
Drug names
Velcade-based chemotherapy
Primary outcome measure
Independence of haemodialysis, at three months from enrolment.
Secondary outcome measures
1. Investigation of the efficiency of extended haemodialysis (HD) using the Gambro HCO 1100 to result in sustained reductions in sFLC concentrations versus a standard dialysis at days 5, 12 and 21
2. Comparison of the duration of HD before renal recovery
3. Investigation of multiple myeloma response to chemotherapy and suitability for stem cell transplantation at monthly intervals
4. Mortality, using Kaplan-Meier analysis
Overall trial start date
01/09/2007
Overall trial end date
31/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Dialysis dependent acute renal failure (estimated glomerular filtration rate [eGFR] less than 15 ml/min/1.73 m^2)
2. Fulfils diagnostic criteria for the diagnosis of symptomatic de novo multiple myeloma
3. Abnormal serum free light chain (FLC) ratio
4. Myeloma kidney demonstrated on a renal biopsy (cast nephropathy)
5. Ability to give informed consent to partake in study
6. Aged 18 years or older, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90
Participant exclusion criteria
1. Known advanced chronic renal failure (chronic kidney disease [CKD] stage IV; eGFR less than 30 ml/min/1.73 m^2) or evidence of significant chronic damage on renal biopsy
2. Amyloidosis or light chain deposition disease on renal biopsy
3. Previous treatment of multiple myeloma with chemotherapy
4. Haemodynamic instability that precludes unsupported dialysis
5. Significant cardiac disease:
5.1. Myocardial infarction within six months
5.2. Unstable angina
5.3. New York Heart Association (NYHA) class III or IV heart failure
5.4. Clinically significant pericardial disease
5.5. Cardiac amyloidosis
6. Advanced disease or significant co-morbidity with poor short term prognosis, necessitating palliation and no active or disease specific treatment
7. Inability to give informed consent
8. History of allergic reaction to compounds containing boron or mannitol
9. History of peripheral neuropathy or neuropathic pain (grade two or higher)
10. Clinically significant liver dysfunction (bilirubin greater than 1.8 mg/dl [30 umol/L])
11. Known human immunodeficiency virus (HIV) infection
12. Active uncontrolled infection
13. Pregnant/lactating women
Recruitment start date
01/09/2007
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Germany, United Kingdom
Trial participating centre
Queen Elizabeth Medical Centre
Birmingham
B15 2TH
United Kingdom
Sponsor information
Organisation
University Hospital Birmingham NHS Foundation Trust (UK)
Sponsor details
Queen Elizabeth Medical Centre
Birmingham
B15 2TH
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Gambro Dialysatoren GmbH (Germany) (ref: study number 1454)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18822172
Publication citations
-
Protocol
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, 9, 55, doi: 10.1186/1745-6215-9-55.