Clinical trial · Interventional
European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy
NCT00700531CI-TRIAL-00024153EuLITEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cast Nephropathy | — | UNRESOLVED | — |
| Kidney Failure | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FLC removal HD (Gambro HCO 1100) | Device | — | UNRESOLVED |
| Standard dialysis on a high flux ployflux dialyser | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Participants will receive FLC removal HD undertaken using an extended dialysis schedule on the Gambro HCO 1100 dialysers
- interventionNames
- Device: FLC removal HD (Gambro HCO 1100)
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Patients receive standard dialysis on a high flux ployflux dialyser at a frequency determined by the duty nephrologist
- interventionNames
- Procedure: Standard dialysis on a high flux ployflux dialyser
Primary outcomes (1)
- measure
- Independence of haemodialysis at 3 months from enrollment (eGFR > 15mls/min/1.73m2 at 2 weeks after last dialysis session)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDHutchison CA, Cockwell P, Reid S, Chandler K, Mead GP, Harrison J, Hattersley J, Evans ND, Chappell MJ, Cook M, Goehl H, Storr M, Bradwell AR. Efficient removal of immunoglobulin free light chains by hemodialysis for multiple myeloma: in vitro and in vivo studies. J Am Soc Nephrol. 2007 Mar;18(3):886-95. doi: 10.1681/ASN.2006080821. Epub 2007 Jan 17. PMID 17229909
- BACKGROUNDHutchison CA, Harding S, Mead G, Goehl H, Storr M, Bradwell A, Cockwell P. Serum free-light chain removal by high cutoff hemodialysis: optimizing removal and supportive care. Artif Organs. 2008 Dec;32(12):910-7. doi: 10.1111/j.1525-1594.2008.00653.x. PMID 19133018
- BACKGROUNDHutchison CA, Cook M, Heyne N, Weisel K, Billingham L, Bradwell A, Cockwell P. European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): a randomised control trial. Trials. 2008 Sep 28;9:55. doi: 10.1186/1745-6215-9-55. PMID 18822172