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    Summary
    EudraCT Number:2007-003968-22
    Sponsor's Protocol Code Number:ETFLCHD01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2007-003968-22
    A.3Full title of the trial
    European Trial of Free Light Chain Removal by Extended Haemodialysis in Cast Nephropathy
    A.3.2Name or abbreviated title of the trial where available
    EuLITE
    A.4.1Sponsor's protocol code numberETFLCHD01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Hospital Birmingham
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Velcade
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBortezomib
    D.3.9.1CAS number 179324-69-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDexamethasone
    D.3.9.1CAS number 500202
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8 pro 2ml
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDoxorubicin
    D.3.9.1CAS number 23214928
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeAntineoplastic cytotaxis agent
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with first diagnosis of multiple myeloma and dialysis dependent acute renal failure secondary to cast nephropathy
    Patienten mit neu diagnostiziertem Multiplen Myelom und dialysepflichtigem Nierenersagen bei Cast Nephropathie
    E.1.1.1Medical condition in easily understood language
    Patients with first diagnosis of multiple myeloma and dialysis dependent acute renal failure secondary to cast nephropathy
    Patienten mit neu diagnostiziertem Multiplen Myelom und dialysepflichtigem Nierenersagen bei Cast Nephropathie
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10028566
    E.1.2Term Myeloma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10038436
    E.1.2Term Renal failure acute
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10028569
    E.1.2Term Myelomatosis multiple
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10018875
    E.1.2Term Haemodialysis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to address the hypothesis that, in combination with trial chemotherapy, extended haemodialysis (HD), using the high cut-off protein permeable Gambro HCO 1100 dialyser, increases the percentage of patients with cast nephropathy becoming independent of dialysis, as compared to conventional HD
    E.2.2Secondary objectives of the trial
    1) Investigation of the efficacy of extended HD using the Gambro HCO 1100 to result in sustained reductions in sFLC concentrations versus conventional HD.
    2)It is proposed that patients with a cast nephropathy will recover their renal function more rapidly if their sFLC levels are reduced quickly. We will observe the duration of requirement for HD between the treatment and the control arms of the study.
    3)The management of patients with MM is limited by renal impairment. It is conceivable that patients who recover renal function will have an increased chance of being suitable for high dose melphalan and stem cell transplantation, which is the current standard of care after primary chemotherapy. Response to treatment of MM will be documented at 6 and 12 months. Whether patients have received a stem cell transplant will be recorded at 12 months.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age  18 years
    • Dialysis dependent acute renal failure (eGFR < 15 mls/min/1.73m²)
    • Fulfils criteria for the diagnosis of symptomatic de novo MM1
    • Abnormal sFLC ratio and sFLC concentration > 500 mg/L
    • Myeloma kidney demonstrated on a renal biopsy (cast nephropathy)
    • Pre-menopausal female patients of childbearing potential: negative pregnancy test at enrolment and willingness to use effective contraception during the study and for 3 months after the end-of- study visit
    • Ability to understand objectives and risks of the trial and to comply with protocol requirements
    • Signed written informed consent
    • Commencement of study within 10 days of presenting to enrolling unit
    E.4Principal exclusion criteria
    • Patients not meeting inclusion criteria
    • Known advanced chronic renal failure (CKD stage IV-V; 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 before this presentation with acute renal failure, except for dexamethasone
    • Haemodynamic instability that precludes unsupported 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)
    • Advanced disease or significant co-morbidity: with poor short term prognosis, necessitating palliation and no active or disease specific treatment.
    • History of allergic reaction attributable to compounds containing boron or mannitol
    • Peripheral neuropathy or neuropathic pain (grade 2 or higher as defined by NCI CTCAE version 3)
    • Clinically significant liver dysfunction (bilirubin > 1.8mg/dl (30 µmol/L))
    • Known HIV infection
    • Active uncontrolled infection
    • Participation in another investigational study within 90 days prior to enrolment
    • No contraception (men and pre-menopausal women)
    • Pregnancy and lactation
    • Any clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary analysis for the trial is to compare the experimental treatment to the control treatment in terms of independence of dialysis at three months. The proportion of patients independent of dialysis will be compared using relative risks and chi-square tests. The analysis will be carried out on an intention-to-treat basis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Independence of dialysis at three months after enrolment
    E.5.2Secondary end point(s)
    Efficacy of extended haemodialysis with respect to reduction of sFLC concentrations
    E.5.2.1Timepoint(s) of evaluation of this end point
    Daily measurement during bortezomib-treatment (max. 8 PAD cycles), afterwards single measurements at month 3, 6, 12 and 24 during follow up phase.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    conventional haemodialysis
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Regular termination of trial for each patient is completion of the last study visit at 24 months. The investigator will counsel the patient regarding continuation of follow-up outside the trial either in the regular outpatient clinic of the study site or by their local haematologist and or nephrologist. At regular termination of trial, patients have no trial related medication. The study is closed upon the last patient having completed the 24 month study visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 90
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-30
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