Condition category
Cancer
Date applied
10/07/2007
Date assigned
26/03/2008
Last edited
04/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www2.uhb.nhs.uk/Homepage.aspx

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

Results - basic reporting

Publication summary

2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18822172

Publication citations

  1. 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.

Additional files

Editorial Notes