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

• Conditions: Acute Kidney Injury; Multiple Myeloma; Cast Nephropathy
• Interventions: Device: KIDNEY therapy

• Registration Number: NCT02358980
• Lead Sponsor: Arcispedale Santa Maria Nuova-IRCCS

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.

Study Timeline

• Study Start: 2014-07
• Status Verified: 2015-02
• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-02-06
• Last Update Submitted: 2015-02-06
• Study First Posted: 2015-02-09
• Last Update Posted: 2015-02-09
• Primary Completion: 2015-12
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	KIDNEY therapy	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.

Primary Outcome Measures

Name	Time	Method
Independence of haemodialysis at 3 months from enrollment	3 months from enrollment

Secondary Outcome Measures

Name	Time	Method
Efficency of KIDNEY therapy system with respect to reduced sFLC levels	21 days from enrollment
Duration of HD from renal recover	3 months from enrollment

Trial Locations

Locations (1)

Nephrology and Dialysis Unit ASMN IRCCS; 🇮🇹 Reggio Emilia, Italy