Clinical trial · Observational
Kidney Therapy for Free Light Chain Removal in Patients With Multiple Myeloma & Cast Nephropathy
KIDNEY THERAPY FOR FREE LIGHT CHAIN REMOVAL IN PATIENTS WITH MULTIPLE MYELOMA & CAST NEPHROPATHY
NCT02358980CI-TRIAL-00091331KEEPERcompletedClinicalTrials.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 (FLC) 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 evaluate patients with multiple myeloma and severe renal failure treated with KIDNEY Therapy (previously called SUPRA HFR) to remove free light chains.
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 |
|---|---|---|---|
| Acute Kidney Injury | — | UNRESOLVED | — |
| Cast Nephropathy | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KIDNEY therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study group
- description
- Participants will receive FLC removal HD undertaken using an extended dialysis schedule on KIDNEY therapy system. Treatments (4 hours each) were carried out for 8 consecutive days and then every other day.
- interventionNames
- Device: KIDNEY therapy
Primary outcomes (1)
- measure
- Independence of haemodialysis at 3 months from enrollment
- timeFrame
- 3 months from enrollment
Secondary outcomes (2)
- measure
- Efficency of KIDNEY therapy system with respect to reduced sFLC levels
- timeFrame
- 21 days from enrollment
- measure
- Duration of HD from renal recover
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 years * Dialysis dependent acute renal failure * Fulfils diagnostic criteria for the diagnosis of symptomatic de novo multiple myeloma * 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: * 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 * Active uncontrolled infection * Inability to give informed consent
References
Publications (6)
- RESULTWinearls CG. Acute myeloma kidney. Kidney Int. 1995 Oct;48(4):1347-61. doi: 10.1038/ki.1995.421. No abstract available. PMID 8569099
- RESULTHaubitz M, Peest D. Myeloma--new approaches to combined nephrological-haematological management. Nephrol Dial Transplant. 2006 Mar;21(3):582-90. doi: 10.1093/ndt/gfi318. Epub 2006 Jan 5. No abstract available. PMID 16396976
- RESULTHutchison 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
- RESULTHutchison CA, Blade J, Cockwell P, Cook M, Drayson M, Fermand JP, Kastritis E, Kyle R, Leung N, Pasquali S, Winearls C; International Kidney and Monoclonal Gammopathy Research Group. Novel approaches for reducing free light chains in patients with myeloma kidney. Nat Rev Nephrol. 2012 Feb 21;8(4):234-43. doi: 10.1038/nrneph.2012.14. PMID 22349488
- RESULTTesta A, Dejoie T, Lecarrer D, Wratten M, Sereni L, Renaux JL. Reduction of free immunoglobulin light chains using adsorption properties of hemodiafiltration with endogenous reinfusion. Blood Purif. 2010;30(1):34-6. doi: 10.1159/000316684. Epub 2010 Jun 24. PMID 20588010
- RESULTPasquali S, Iannuzzella F, Corradini M, Mattei S, Bovino A, Stefani A, Palladino G, Caiazzo M. A novel option for reducing free light chains in myeloma kidney: supra-hemodiafiltration with endogenous reinfusion (HFR). J Nephrol. 2015 Apr;28(2):251-4. doi: 10.1007/s40620-014-0130-8. Epub 2014 Aug 23. PMID 25149172