Multiple MyelomaEuLITENCT00700531
European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy
A study testing FLC removal HD (Gambro HCO 1100) and Standard dialysis on a high flux ployflux dialyser in people with Multiple Myeloma and Cast Nephropathy, run by University Hospital Birmingham at 1 site in United Kingdom.
Trial summary
Hypothesis: Free light chain 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 randomise patients with multiple myeloma and severe renal failure to treatment to remove free light chains by haemodialysis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Cast Nephropathy, Kidney Failure
- What is being tested?
- FLC removal HD (Gambro HCO 1100) and Standard dialysis on a high flux ployflux dialyser
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2008to Oct 2015
- Phase
- Interventional
- 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
Who may be able to join
- Age >= 18 years
- Dialysis dependent acute renal failure (eGFR <15ml/min/1.73m2)
- Fulfils diagnostic criteria for the diagnosis of symptomatic de novo multiple myeloma1
- 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
- Age < 18 years
- 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 (myocardial infarction with in the last 6 months; unstable angina; NYHA class III or IV heart failure; clinically significant pericardial disease; cardiac amyloidosis)
Show all 17Show fewer
- Advanced disease or significant co-morbidity: with poor short term prognosis, necessitating palliation and no active or disease specific treatment.
- Inability to give informed consent
- History of allergic reaction attributable to compounds containing boron or mannitol
- History of Peripheral neuropathy or neuropathic pain (grade 2 or higher as defined by NCI CTCAE version 3)
- Clinically significant liver dysfunction (bilirubin >1.8mg/dl (30µmol/L))
- Known HIV infection
- Active uncontrolled infection
- Pregnant and lactating women
- Inability to give informed consent
- Pre-menopausal female patients of childbearing potential: positive pregnancy test or unwilling to use effective contraception during the study
- Lactation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Birmingham
Birmingham, West Midlands, B15 2GW
About this study
Hypothesis: Free light chain 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 randomise patients with multiple myeloma and severe renal failure to treatment to remove free light chains by haemodialysis or not.
Read the detailed description
The EUropean trial of free LIght chain removal by exTEnded haemodialysis in cast nephropathy (EuLITE) trial is a prospective, randomised, multicentre, open label clinical trial to investigate the clinical benefit of FLC removal haemodialysis in patients with cast nephropathy, dialysis dependent renal failure and de novo multiple myeloma. Recruitment commenced in May 2008, in total 90 patients will be recruited. Participants will be randomised, centrally, upon enrolment, to either trial chemotherapy and FLC removal haemodialysis or trial chemotherapy and standard high flux haemodialysis. Trial chemotherapy is a modified PAD regime, consisting of bortezomib, doxorubicin and dexamethasone. FLC removal haemodialysis is undertaken using two Gambro HCO 1100 dialysers in series, over an intensive treatment schedule. The primary outcome for the study is independence of dialysis at 3 months. Secondary outcomes are: duration of dialysis, reduction in serum FLC concentrations; myeloma response and survival.
- Conditions
- Multiple Myeloma, Cast Nephropathy, Kidney Failure
- Being tested
- FLC removal HD (Gambro HCO 1100), Standard dialysis on a high flux ployflux dialyser
- Keywords
- Hemodialysis, Multiple myeloma, Cast nephropathy, Kidney failure
- Medical subject headings
- Multiple Myeloma, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLC removal HD (Gambro HCO 1100)Device
Also called Gambro HCO 1100
FLC removal HD using a extended dialysis schedule on the Gambro HCO 1100
Standard dialysis on a high flux ployflux dialyserProcedure or surgery
Standard dialysis on a high flux ployflux dialyser at a frequency determined by the duty nephrologist
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive FLC removal HD undertaken using an extended dialysis schedule on the Gambro HCO 1100 dialysers Receives: Device: FLC removal HD (Gambro HCO 1100) |
| 2 | Active comparator | Patients receive standard dialysis on a high flux ployflux dialyser at a frequency determined by the duty nephrologist Receives: Procedure: Standard dialysis on a high flux ployflux dialyser |
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 (eGFR > 15mls/min/1.73m2 at 2 weeks after last dialysis session)
Measured: 3 months from enrollment
Secondary outcomes (1)
Efficiency of extended HD with respect to reduced sFLC concentrations; duration of HD before renal recovery; multiple myeloma response to chemotherapy and suitability for stem cell transplantation; mortality over 24 months observation period
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Gambro Renal Products, Inc., Ortho Biotech, Inc.
- Responsible party
- Principal investigator, Paul Cockwell, University Hospital Birmingham
- Investigators
- Paul Cockwell, PhD FRCP, Principal investigator, University Hospital BirminghamMark Cook, PhD FRCPath, Principal investigator, University Hospital Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700531
- Sponsor's protocol ID
- EudraCT 2007-003968-22
- Other IDs
- ISRCTN45967602
- Acronym
- EuLITE
- Status last verified
- Oct 2016
- First submitted
- 13 Jun 2008
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Under consideration
Publications
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.
PubMed 17229909Hutchison CA, Harding S, Mead G, Goehl H, Storr M, Bradwell A, Cockwell P. Serum free-light chain removal by high cutoff hemodialysis: optimizing removal and supportive care. Artif Organs. 2008 Dec;32(12):910-7. doi: 10.1111/j.1525-1594.2008.00653.x.
PubMed 19133018Hutchison CA, Cook M, Heyne N, Weisel K, Billingham L, Bradwell A, Cockwell P. European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): a randomised control trial. Trials. 2008 Sep 28;9:55. doi: 10.1186/1745-6215-9-55.
PubMed 18822172
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy
- ClinicalTrials.gov ID
- NCT00700531
- Acronym / sponsor ID
- EuLITE / EudraCT 2007-003968-22
- Conditions
- Multiple Myeloma, Cast Nephropathy, Kidney Failure
- Keywords
- Hemodialysis, Multiple myeloma, Cast nephropathy, Kidney failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital BirminghamUniversity, hospital or other
- Collaborators
- Gambro Renal Products, Inc., Ortho Biotech, Inc.
- Study start
- Jun 2008
- Primary completion
- Jan 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 18 Jun 2008 (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 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 randomise patients with multiple myeloma and severe renal failure to treatment to remove free light chains by haemodialysis or not.
Detailed description
The EUropean trial of free LIght chain removal by exTEnded haemodialysis in cast nephropathy (EuLITE) trial is a prospective, randomised, multicentre, open label clinical trial to investigate the clinical benefit of FLC removal haemodialysis in patients with cast nephropathy, dialysis dependent renal failure and de novo multiple myeloma. Recruitment commenced in May 2008, in total 90 patients will be recruited. Participants will be randomised, centrally, upon enrolment, to either trial chemotherapy and FLC removal haemodialysis or trial chemotherapy and standard high flux haemodialysis. Trial chemotherapy is a modified PAD regime, consisting of bortezomib, doxorubicin and dexamethasone. FLC removal haemodialysis is undertaken using two Gambro HCO 1100 dialysers in series, over an intensive treatment schedule. The primary outcome for the study is independence of dialysis at 3 months. Secondary outcomes are: duration of dialysis, reduction in serum FLC concentrations; myeloma response and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: FLC removal HD (Gambro HCO 1100)Participants will receive FLC removal HD undertaken using an extended dialysis schedule on the Gambro HCO 1100 dialysers |
| 2 | Active comparator | Procedure: Standard dialysis on a high flux ployflux dialyserPatients receive standard dialysis on a high flux ployflux dialyser at a frequency determined by the duty nephrologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >= 18 years
- Dialysis dependent acute renal failure (eGFR <15ml/min/1.73m2)
- Fulfils diagnostic criteria for the diagnosis of symptomatic de novo multiple myeloma1
- Abnormal serum FLC ratio and a sFLC concentration > 500 mg/L
- Myeloma kidney demonstrated on a renal biopsy (cast nephropathy)
Key exclusion criteria (17 listed)
- Age < 18 years
- 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
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 |
|---|---|---|
| FLC removal HD (Gambro HCO 1100)Also: Gambro HCO 1100FLC removal HD using a extended dialysis schedule on the Gambro HCO 1100 | Device | 1 |
| Standard dialysis on a high flux ployflux dialyserStandard dialysis on a high flux ployflux dialyser at a frequency determined by the duty nephrologist | Procedure or surgery | 2 |
Primary outcome
Independence of haemodialysis at 3 months from enrollment (eGFR > 15mls/min/1.73m2 at 2 weeks after last dialysis session)
Time frame: 3 months from enrollment
1 secondary outcome
Efficiency of extended HD with respect to reduced sFLC concentrations; duration of HD before renal recovery; multiple myeloma response to chemotherapy and suitability for stem cell transplantation; mortality over 24 months observation period
Time frame: 24 months
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 5 Oct 2016.
- Background: 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.
- Background: PubMed 19133018Hutchison CA, Harding S, Mead G, Goehl H, Storr M, Bradwell A, Cockwell P. Serum free-light chain removal by high cutoff hemodialysis: optimizing removal and supportive care. Artif Organs. 2008 Dec;32(12):910-7. doi: 10.1111/j.1525-1594.2008.00653.x.
- Background: PubMed 18822172Hutchison CA, Cook M, Heyne N, Weisel K, Billingham L, Bradwell A, Cockwell P. European trial of free light chain removal by extended haemodialysis in cast nephropathy (EuLITE): a randomised control trial. Trials. 2008 Sep 28;9:55. doi: 10.1186/1745-6215-9-55.
- Individual participant dataSharing planned: Undecided. Under consideration
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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.
Paul Cockwell, PhD FRCP principal investigator
University Hospital Birmingham
Mark Cook, PhD FRCPath principal investigator
University Hospital Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLC removal HD (Gambro HCO 1100) and Standard dialysis on a high flux ployflux dialyser in people with Multiple Myeloma and Cast Nephropathy, run by University Hospital Birmingham at 1 site in United Kingdom.
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 17 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 5 Oct 2016. 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 United Kingdom. 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 (eGFR > 15mls/min/1.73m2 at 2 weeks after last dialysis session) (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 NCT00700531, which also lists 3 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 5 Oct 2016.