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

June 13, 2008
July 6, 2010
June 2008
June 2011   (final data collection date for primary outcome measure)
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 ]
Independence of haemodialysis at 3 months from enrolment (eGFR > 15mls/min/1.73m2 at 2 weeks after last dialysis session) [ Time Frame: 3 months from enrolment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00700531 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy
European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Multiple Myeloma
  • Cast Nephropathy
  • Kidney Failure
  • 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
  • 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
  • Experimental: 1
    Participants will receive FLC removal HD undertaken using an extended dialysis schedule on the Gambro HCO 1100 dialysers
    Intervention: Device: FLC removal HD (Gambro HCO 1100)
  • Active Comparator: 2
    Patients receive standard dialysis on a high flux ployflux dialyser at a frequency determined by the duty nephrologist
    Intervention: Procedure: Standard dialysis on a high flux ployflux dialyser

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
June 2012
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Colin A Hutchison, MBChB, PhD 447723917870 c.a.hutchison@bham.ac.uk
United Kingdom
 
NCT00700531
EudraCT 2007-003968-22, ISRCTN45967602
Yes
Dr Paul Cockwell, University Hospital Birmingham
University Hospital Birmingham
  • Gambro Renal Products, Inc.
  • Ortho Biotech, Inc.
Principal Investigator: Paul Cockwell, MBChB University Hospital Birmingham
Principal Investigator: Mark Cook, MBChB University Hospital Birmingham
University Hospital Birmingham
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP