- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02358980
Kidney Therapy for Free Light Chain Removal in Patients With Multiple Myeloma & Cast Nephropathy (KEEPER)
February 6, 2015 updated by: Sonia Pasquali, Arcispedale Santa Maria Nuova-IRCCS
KIDNEY THERAPY FOR FREE LIGHT CHAIN REMOVAL IN PATIENTS WITH MULTIPLE MYELOMA & CAST NEPHROPATHY
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Reggio Emilia, Italy, 42123
- Recruiting
- Nephrology and Dialysis Unit ASMN IRCCS
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Contact:
- Sonia Pasquali, MD
- Phone Number: +39 0522296492
- Email: sonia.pasquali@asmn.re.it
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Contact:
- Francesco Iannuzzella, MD
- Phone Number: +39 0522296491
- Email: francesco.iannuzzella@asmn.re.it
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with cast nephropathy, dialysis dependent renal failure and de novo multiple myeloma
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Independence of haemodialysis at 3 months from enrollment
Time Frame: 3 months from enrollment
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3 months from enrollment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficency of KIDNEY therapy system with respect to reduced sFLC levels
Time Frame: 21 days from enrollment
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21 days from enrollment
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Duration of HD from renal recover
Time Frame: 3 months from enrollment
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3 months from enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Winearls CG. Acute myeloma kidney. Kidney Int. 1995 Oct;48(4):1347-61. doi: 10.1038/ki.1995.421. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
July 1, 2016
Study Registration Dates
First Submitted
February 4, 2015
First Submitted That Met QC Criteria
February 6, 2015
First Posted (Estimate)
February 9, 2015
Study Record Updates
Last Update Posted (Estimate)
February 9, 2015
Last Update Submitted That Met QC Criteria
February 6, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Urologic Diseases
- Hematologic Diseases
- Renal Insufficiency
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Kidney Diseases
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Acute Kidney Injury
Other Study ID Numbers
- 73/2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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