European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy (EuLITE)

October 4, 2016 updated by: Paul Cockwell, University Hospital Birmingham

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2GW
        • University Hospital Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will receive FLC removal HD undertaken using an extended dialysis schedule on the Gambro HCO 1100 dialysers
Device: FLC removal HD (Gambro HCO 1100)
FLC removal HD using a extended dialysis schedule on the Gambro HCO 1100
Other Names:
  • Gambro HCO 1100
Active Comparator: 2
Patients receive standard dialysis on a high flux ployflux dialyser at a frequency determined by the duty nephrologist
Procedure: Standard dialysis on a high flux ployflux dialyser
Standard dialysis on a high flux ployflux dialyser at a frequency determined by the duty nephrologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months from enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Birmingham

Collaborators

Ortho Biotech, Inc.
Gambro Renal Products, Inc.

Investigators

  • Principal Investigator: Paul Cockwell, PhD FRCP, University Hospital Birmingham
  • Principal Investigator: Mark Cook, PhD FRCPath, University Hospital Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

October 5, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT 2007-003968-22
  • ISRCTN45967602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Under consideration

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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