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    Summary
    EudraCT Number:2011-003791-37
    Sponsor's Protocol Code Number:KFE2011.06
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-30
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2011-003791-37
    A.3Full title of the trial
    Pre-Clinical Phase 0 Microdose Study to evaluate the effect of Melphalan, Bortezomib and Dexamethasone on cellular gene-expression.
    Præklinisk fase 0 mikrodosisstudie til vurdering af Melphalans, Bortezomibs og Dexametasons påvirkning af cellulære genudtryk
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A scientific experiment on patients, to evaluate the effects of various treatments used for bonemarrowcancer, on cells and genes.
    Et videnskabeligt forsøg om behandlingens påvirkning af celler og gener hos patienter, der behandles for knoglemarvskræft.
    A.3.2Name or abbreviated title of the trial where available
    MM phase 0 protokol
    MM fase 0 protokol
    A.4.1Sponsor's protocol code numberKFE2011.06
    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 SponsorDepartment of Haematology, Aalborg University Hospital
    B.1.3.4CountryDenmark
    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 supportHenrik Gregersen, Department of Haematology, Aalborg University Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHenrik Gregersen, Department of Haematology, Aalborg University Hospital
    B.5.2Functional name of contact pointClinical Research Unit
    B.5.3 Address:
    B.5.3.1Street AddressHobrovej 18-22
    B.5.3.2Town/ cityAalborg
    B.5.3.3Post code9000
    B.5.3.4CountryDenmark
    B.5.4Telephone number4599326320
    B.5.5Fax number4599326321
    B.5.6E-maillit@rn.dk
    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 Alkeran 50mg Injection
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires GENOPHARM
    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/infusion
    D.3.4.1Specific paediatric formulation No
    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 INNMELPHALAN
    D.3.9.1CAS number 148-82-3
    D.3.9.3Other descriptive nameL-Phenylalanine Mustard
    D.3.9.4EV Substance CodeSUB08728MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 typeAlkylating cytostatic agent.
    D.IMP: 2
    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 1.0 pulver til injektionsvæske, opløsning.
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Pharmaceutica N.V.
    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 infusion
    D.3.4.1Specific paediatric formulation No
    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.3.9.3Other descriptive namePS341
    D.3.9.4EV Substance CodeSUB20020
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 typeCytostatic agent.
    D.IMP: 3
    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 DEXAVEN 4mg/ml, solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderPharmaceutical Company Jelfa SA
    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 Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 312-93-6
    D.3.9.3Other descriptive nameDEXAMETHASONE PHOSPHATE
    D.3.9.4EV Substance CodeSUB01612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 typeSynthetic glucocorticoid.
    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
    Multiple Myelomatosis (MM).
    Myelomatose.
    E.1.1.1Medical condition in easily understood language
    Bonemarrow Cancer.
    Knoglemarvskræft.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10028569
    E.1.2Term Myelomatosis multiple
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To identify the specific genes that is up- or downregulated in patiaents who receive a microdose of either Melphalan (Alkeran), Bortezomib (Velcade) or Dexamethasone (Dexaven).
    At identificere de enkelte gener der enten op- eller nedreguleres, hos patienter der får en mikrodosis af enten Melphalan, Bortezomib, eller Dexametason,
    E.2.2Secondary objectives of the trial
    Identify specific mechanisms of action and pathways for each individual drug, based on the genes found to be up- or down regulated during the experiment.
    Further, in the future, to combine results from this study with tecniques and use of biomarkers, in development of methods that can be used to predict the individual patient response to therapy.
    På baggrund af fundne gener der påvirkes, at identificere specifikke virkningsmekanismer og pathways for det enkelte lægemiddel.
    Endvidere, på sigt, at udnytte opnået viden fra dette studie, i kombination med viden om teknikker og biomarkører, til udvikling af metoder som kan prædiktere den individuelle patients respons på behandling.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Any patient who,
    • is set start a planned treatment for Multiple Myelomatosis (Newly diagnosed as well as relaps and refractory disease) with one of the following chemotherapy regimens: Highdose Alkeran (includes melphalan), or VEL-DEX/Velcade therapy alone (includes Bortezomib), or VEL-DEX/Dexaven therapy alone (Includes Dexaven).
    • is 18 years or older.
    • can understand and have the will to sign the informed consent.
    Enhver patient som,
    • skal opstarte et behandlingsforløb for myelomatose (nydiagnosticeret såvel som relaps og refraktær sygdom) med en af kemoterapiserierne, Højdosis Alkeran (hvor lægemidlet Melphalan indgår), eller VEL-DEX/Bortezomib alene (hvor lægemidlet bortezomib indgår), eller VEL-DEX/Dexametason alene (hvor lægemidlet Dexametason indgår).
    • er over 18 år gammel.
    • har evnen til at forstå og vilje til at underskrive informeret samtykkeerklæring
    E.4Principal exclusion criteria
    Any patient who,
    • have their planned treatment cancelled immediately prior to the experiment.
    • have received treatment with biphosphonates in the week prior to the experiment.
    Enhver patient som,
    • På forsøgsdagen får deres kemoterapiserie aflyst af tilseende læge i ambulatoriets modtagelse.
    • Har fået behandling med biphosphonater (Aredia®) i løbet af ugen forud for forsøgsdagen.
    E.5 End points
    E.5.1Primary end point(s)
    To identify the specific genes that is up- or downregulated in patiaents who receive a microdose of either Melphalan (Alkeran), Bortezomib (Velcade) or Dexamethasone (Dexaven).
    At identificere de enkelte gener, der enten op- eller nedreguleres hos patienter, der får en mikrodosis af enten Melphalan (Alkeran), Bortezomib (Velcade), eller Dexametason (Dexaven),
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before 01.12.2015
    Før 01.12.2015
    E.5.2Secondary end point(s)
    Identify specific mechanisms of action and pathways for each individual drug, based on the genes found to be up- or down regulated during the experiment.
    Further, in the future, to combine results from this study with tecniques and use of biomarkers, in development of methods that can be used to predict the individual patient response to therapy.
    At identificere specifikke virkningsmekanismer og pathways for det enkelte lægemiddel på baggrund af fundne gener, der påvirkes.
    På sigt, at anvende opnået viden fra dette studie, i kombination med viden om teknikker og biomarkører, til udvikling af metoder, som kan prædiktere den individuelle patients respons på behandling.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Before 01.12.2015
    Før 01.12.2015
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 0 microdose trial
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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
    Baseline genudtryk.
    Baseline gene expression level.
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVLS
    Sidste besøg af sidste forsøgsperson
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 21
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 21
    F.4.2.2In the whole clinical trial 21
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not different from the expected normal treatment of multiple myelomatosis.
    Ikke forskellig fra normal forventet myelomatosebehandling.
    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 Decision2011-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-31
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