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
Recruitment status was Recruiting
Sponsor:
University Hospital Birmingham
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
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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 May 23, 2013