Kidney Therapy for Free Light Chain Removal in Patients With Multiple Myeloma & Cast Nephropathy

Multiple Myeloma Clinical Trial

— KEEPER  

Official title:

KIDNEY THERAPY FOR FREE LIGHT CHAIN REMOVAL IN PATIENTS WITH MULTIPLE MYELOMA & CAST NEPHROPATHY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02358980
• Other study ID #: 73/2014
• Status: Recruiting
• Phase: N/A
• First received: February 4, 2015
• Last updated: February 6, 2015
• Start date: July 2014
• Est. completion date: July 2016

Study information

• Verified date: February 2015
• Source: Arcispedale Santa Maria Nuova-IRCCS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cast Nephropathy
• Kidney Diseases
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Device:
• KIDNEY therapy

Locations

Country	Name	City	State
Italy	Nephrology and Dialysis Unit ASMN IRCCS	Reggio Emilia

Sponsors (1)

Lead Sponsor	Collaborator
Arcispedale Santa Maria Nuova-IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Haubitz M, Peest D. Myeloma--new approaches to combined nephrological-haematological management. Nephrol Dial Transplant. 2006 Mar;21(3):582-90. Epub 2006 Jan 5. Review. — View Citation

Hutchison CA, Bladé 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 — View 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 — View 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: — View 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 2 — View Citation

Winearls CG. Acute myeloma kidney. Kidney Int. 1995 Oct;48(4):1347-61. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Independence of haemodialysis at 3 months from enrollment		3 months from enrollment	No
Secondary	Efficency of KIDNEY therapy system with respect to reduced sFLC levels		21 days from enrollment	No
Secondary	Duration of HD from renal recover		3 months from enrollment	No