European trial of free light chain removal by extended haemodialysis in cast nephropathy

ISRCTN	ISRCTN45967602
DOI	https://doi.org/10.1186/ISRCTN45967602
EudraCT/CTIS number	2007-003968-22
ClinicalTrials.gov number	NCT00700531
Secondary identifying numbers	1.0

Submission date: 10/07/2007
Registration date: 26/03/2008
Last edited: 19/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Colin Hutchison
Scientific

Queen Elizabeth Medical Centre
Birmingham
B15 2TH
United Kingdom

Phone	+44 (0)121 472 1311
Email	c.a.hutchison@bham.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	European trial of free light chain removal by extended haemodialysis in cast nephropathy
Study acronym	EuLITE
Study objectives	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(s)	Central Office for Research Ethics Committees (COREC), 04/02/2008, ref: 07/H1307/133
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/09/2007
Completion date	31/12/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	90
Key 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
Key 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
Date of first enrolment	01/09/2007
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

England
Germany
United Kingdom

Study participating centre

Queen Elizabeth Medical Centre

Birmingham
B15 2TH
United Kingdom

Sponsor information

University Hospital Birmingham NHS Foundation Trust (UK)
Hospital/treatment centre

Queen Elizabeth Medical Centre
Birmingham
B15 2TH
England
United Kingdom

Website	http://www2.uhb.nhs.uk/Homepage.aspx
"ROR"	https://ror.org/014ja3n03

Funders

Funder type

Industry

Gambro Dialysatoren GmbH (Germany) (ref: study number 1454)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	2016 results presented at ASN Kidney Week 2016: https://www.asn-online.org/education/kidneyweek/2016/KW16_Onsite_Program.pdf
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	28/09/2008		Yes	No
Results article	results	01/04/2019		Yes	No

Editorial Notes

19/03/2020: EudraCT number added.
18/03/2019: Publication reference added.
29/10/2018: The publication and dissemination plan was updated.