Clinical trial NCT02358980: Kidney Therapy for Free Light Chain Removal in Patients With Multiple Myeloma & Cast Nephropathy
Official title: KIDNEY THERAPY FOR FREE LIGHT CHAIN REMOVAL IN PATIENTS WITH MULTIPLE MYELOMA & CAST NEPHROPATHY
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Cast Nephropathy
Acute Kidney Injury
Keywords: Multiple Myeloma
Cast Nephropathy
Acute kidney injury
KIDNEY THERAPY
HFR
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2015-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cast nephropathy, dialysis dependent renal failure and de novo multiple myeloma

Brief summary: 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.

Detailed description: This is an observational study performed to investigate the clinical benefit of FLC removal by KIDNEY therapy system in patients with cast nephropathy, dialysis dependent renal failure and de novo multiple myeloma. Recruitment commenced in July 2014, in total 20 patients will be recruited. Participants will be treated with, KIDNEY therapy system (Bellco Mirandola, Modena, Italy) . The KIDNEY system is a kind of haemodiafiltration that utilizes separated convection, diffusion and adsorption. The sorbent cartridge has a high affinity for FLC (both κ and λ) but is able to re-infuse albumin, avoiding the need for albumin perfusions. The KIDNEY therapy will be undertaken over an intensive treatment schedule. The primary outcome for the study is independence of dialysis in 3 month. Secondary outcomes are: duration dialysis, reduction of serum FLC levels, myeloma response and survival.

Eligibility criteria: 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

Primary outcomes:
measure: Independence of haemodialysis at 3 months from enrollment
timeFrame: 3 months from enrollment
Secondary outcomes:
measure: Efficency of KIDNEY therapy system with respect to reduced sFLC levels
timeFrame: 21 days from enrollment
measure: Duration of HD from renal recover
timeFrame: 3 months from enrollment
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Nephrology and Dialysis Unit ASMN IRCCS
Study officials:
References:
citation: Winearls CG. Acute myeloma kidney. Kidney Int. 1995 Oct;48(4):1347-61. doi: 10.1038/ki.1995.421. No abstract available.
citation: Haubitz 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.
citation: Hutchison 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.
citation: Hutchison 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.
citation: Testa 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.
citation: Pasquali 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.