Multiple MyelomaKEEPERNCT02358980
Kidney Therapy for Free Light Chain Removal in Patients With Multiple Myeloma & Cast Nephropathy
An observational study of Multiple Myeloma and Cast Nephropathy, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Cast Nephropathy, Acute Kidney Injury
- What is being tested?
- KIDNEY therapy
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- 18 Feb 2015to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cast nephropathy, dialysis dependent renal failure and de novo multiple myeloma
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Nephrology and Dialysis Unit ASMN IRCCS
Reggio Emilia, Reggio Emilia, 42123
About this study
Official title: 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.
Read the 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
- Being tested
- KIDNEY therapy
- Keywords
- Multiple Myeloma, Cast Nephropathy, Acute kidney injury, KIDNEY THERAPY, HFR
- Medical subject headings
- Multiple Myeloma, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIDNEY therapyDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: KIDNEY therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Independence of haemodialysis at 3 months from enrollment
Measured: 3 months from enrollment
Secondary outcomes (2)
Efficency of KIDNEY therapy system with respect to reduced sFLC levels
Measured: 21 days from enrollment
Duration of HD from renal recover
Measured: 3 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study start18 Feb 2015
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358980
- Sponsor's protocol ID
- 73/2014
- Acronym
- KEEPER
- Status last verified
- Jun 2025
- First submitted
- 4 Feb 2015
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Winearls CG. Acute myeloma kidney. Kidney Int. 1995 Oct;48(4):1347-61. doi: 10.1038/ki.1995.421. No abstract available.
PubMed 8569099Haubitz 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.
PubMed 16396976Hutchison 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.
PubMed 17229909Hutchison 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.
PubMed 22349488Testa 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.
PubMed 20588010Pasquali 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.
PubMed 25149172
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KIDNEY THERAPY FOR FREE LIGHT CHAIN REMOVAL IN PATIENTS WITH MULTIPLE MYELOMA & CAST NEPHROPATHY
- ClinicalTrials.gov ID
- NCT02358980
- Acronym / sponsor ID
- KEEPER / 73/2014
- Conditions
- Multiple Myeloma, Cast Nephropathy, Acute Kidney Injury
- Keywords
- Multiple Myeloma, Cast Nephropathy, Acute kidney injury, KIDNEY THERAPY, HFR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 18 Feb 2015 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: KIDNEY therapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cast nephropathy, dialysis dependent renal failure and de novo multiple myeloma
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KIDNEY therapy | Device | Study group |
Primary outcome
Independence of haemodialysis at 3 months from enrollment
Time frame: 3 months from enrollment
2 secondary outcomes
Efficency of KIDNEY therapy system with respect to reduced sFLC levels
Time frame: 21 days from enrollment
Duration of HD from renal recover
Time frame: 3 months from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Results publication: PubMed 8569099Winearls CG. Acute myeloma kidney. Kidney Int. 1995 Oct;48(4):1347-61. doi: 10.1038/ki.1995.421. No abstract available.
- Results publication: PubMed 16396976Haubitz 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.
- Results publication: PubMed 17229909Hutchison 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.
- Results publication: PubMed 22349488Hutchison 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.
- Results publication: PubMed 20588010Testa 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.
- Results publication: PubMed 25149172Pasquali 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Cast Nephropathy, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Independence of haemodialysis at 3 months from enrollment (time frame: 3 months from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02358980, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.