NCT02358980

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Azienda USL Reggio Emilia - IRCCS · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma
• Cast Nephropathy
• Acute Kidney Injury

Interventions

Type	Name	Description
DEVICE	KIDNEY therapy

Timeline

• Start date: 2015-02-18
• Primary completion: 2018-09-30
• Completion: 2018-09-30
• First posted: 2015-02-09
• Last updated: 2025-06-25

Locations

1 site across 1 country: Italy