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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University Hospital Birmingham.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Gambro Renal Products, Inc.
Ortho Biotech, Inc.
Information provided by:
University Hospital Birmingham
ClinicalTrials.gov Identifier:
NCT00700531
First received: June 13, 2008
Last updated: July 6, 2010
Last verified: March 2009
  Purpose

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.


Condition Intervention
Multiple Myeloma
Cast Nephropathy
Kidney Failure
Device: FLC removal HD (Gambro HCO 1100)
Procedure: Standard dialysis on a high flux ployflux dialyser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy

Resource links provided by NLM:


Further study details as provided by University Hospital Birmingham:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700531

Contacts
Contact: Colin A Hutchison, MBChB, PhD 447723917870 c.a.hutchison@bham.ac.uk

Locations
United Kingdom
University Hospital Birmingham Recruiting
Birmingham, West Midlands, United Kingdom, B152TH
Contact: Colin Hutchison, MBChB    447723917870    c.a.hutchison@bham.ac.uk   
Sponsors and Collaborators
University Hospital Birmingham
Gambro Renal Products, Inc.
Ortho Biotech, Inc.
Investigators
Principal Investigator: Paul Cockwell, MBChB University Hospital Birmingham
Principal Investigator: Mark Cook, MBChB University Hospital Birmingham
  More Information

Publications:
Responsible Party: Dr Paul Cockwell, University Hospital Birmingham
ClinicalTrials.gov Identifier: NCT00700531     History of Changes
Other Study ID Numbers: EudraCT 2007-003968-22, ISRCTN45967602
Study First Received: June 13, 2008
Last Updated: July 6, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by University Hospital Birmingham:
Hemodialysis
Multiple myeloma
Cast nephropathy
Kidney failure

Additional relevant MeSH terms:
Kidney Diseases
Multiple Myeloma
Neoplasms, Plasma Cell
Renal Insufficiency
Urologic Diseases
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014