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    The EU Clinical Trials Register currently displays   38153   clinical trials with a EudraCT protocol, of which   6266   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2013-003789-15
    Sponsor's Protocol Code Number:NMSG#20/13
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-03-26
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNorway - NOMA
    A.2EudraCT number2013-003789-15
    A.3Full title of the trial
    Phase II study of carfilzomib- cyclophosphamide-dexamethasone and high-dose melphalan followed by randomization between observa-tion or maintenance with carfil-zomib and dexamethasone in pa-tients with relapsed multiple myeloma after high-dose melphalan with autologous stem cell support
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study of carfilzomib- cyclophosphamide-dexamethasone and high-dose melphalan followed by randomization between observa-tion or maintenance with carfil-zomib and dexamethasone in pa-tients with relapsed multiple myeloma after high-dose melphalan with autologous stem cell support
    Et klinisk prospektivt fase II forsøg - Induktionsbehandling med Carfilzomib, Cyclophosphamid, og Dexamethason, og højdosisbehandling med stamcellestøtte til patienter med tilbagefald af myelomatose efter tidligere højdosisbehandling. Efterfølgende åben, randomiseret vedligeholdelsesbehandling med Carfilzomib/Dexamethason eller observation.
    A.4.1Sponsor's protocol code numberNMSG#20/13
    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 SponsorNordic Myeloma Study Group
    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 supportNordic Myeloma Study Group
    B.4.1Name of organisation providing supportNordic Myeloma Study Group
    B.4.1Name of organisation providing supportNordic Myeloma Study Group
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNordic Myeloma Study Group
    B.5.2Functional name of contact pointClinical Trial Unit Hematology
    B.5.3 Address:
    B.5.3.1Street AddressMoelleparkvej 4
    B.5.3.2Town/ cityAalborg
    B.5.3.3Post code9000
    B.5.4Telephone number004599326320
    B.5.5Fax number004599326321
    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 No
    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.3.1Product namecarfilzomib
    D.3.4Pharmaceutical form Concentrate and solvent 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.3.9.1CAS number 868540-17-4
    D.3.9.3Other descriptive nameCARFILZOMIB
    D.3.9.4EV Substance CodeSUB32911
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 No
    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 Myeloma
    E.1.1.1Medical condition in easily understood language
    Multiple Myeloma
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10067095
    E.1.2Term Multiple myeloma progression
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of our study is to evaluate the effect of the combination of carfilzomib, cyclophosphamide and dexamethasone in the induction regimen and carfilzomib in the conditioning regimen of salvage HDT. In addition to evaluate the potential effect of carfilzomib/dexamethasone maintenance treatment.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Myeloma diagnosis according to IMWG criteria
    • First treatment demanding relapse after HDT according to IMWG criteria
    • More than 2.0 x 106 CD34+ stem cells / kg body weight in the freezer for stem cell support
    • Signed informed consent given prior to any study related activities have been performed
    • Age > 18 years
    E.4Principal exclusion criteria
    • Allogeneic transplantation scheduled as a part of the treatment
    • Treatment demanding relapse less than one year after HDT
    • Myeloma treatment after the first HDT, except radiotherapy, bisphosphonates, denosumab and corticosteroids less than 6 days for symptom control
    • Patients not having received HDT as first line treatment
    • Previous treatment with carfilzomib
    • Expected survival of less than six months
    • Performance status (WHO) ≥ 3

    • Serum M-component < 5 g/l and urine M-component < 200 mg/l
    • Any of the following laboratory abnormalities:
    o Absolute neutrophil count (ANC) < 1.0 × 109/L
    o Hemoglobin < 5 mmol/L (<80 g/L) (prior RBC transfusion or recom-binant human erythropoietin use is permitted)
    o Platelet count < 50 × 109/L (< 30 × 109/L if myeloma involvement in the bone marrow is > 50%)
    o Serum ALT or AST > 3.5 times the upper limit of normal and serum direct bilirubin > 34 µmol/L (2 mg/dL)
    o Creatinine clearance (CrCl) < 15 mL/minute, either measured or cal-culated using a standard formula

    Concurrent conditions
    • Concurrent disease making treatment with carfilzomib, cyclophosphamide or dexamethasone unsuitable
    • Significant neuropathy (Grades 3–4, or Grade 2 with pain) within 14 days prior to enrolment
    • Major surgery within 21 days prior to enrolment
    • Acute active infection requiring treatment
    • Known or suspected hypersensitivity or intolerance to melphalan, dexa-methasone or Captisol® (a cyclodextrin derivative)
    • Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, NYHA Class III or IV heart failure, uncon-trolled angina, clinically significant pericardial disease, uncontrolled severe arrhytmias, or cardiac amyloidosis
    • LVEF <40%, determined by 2-D transthoracic echocardiogram (ECHO) or Multigated Acquisition Scan (MUGA)
    • Pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrolment
    • Serious hepatic disorder, including active hepatitis B or C infection
    • Other serious medical or psychiatric illness likely to interfere with participation in this clinical study
    • Use of any investigational agents or experimental medical device within 28 days prior to enrolment into the study

    • Pregnant or lactating females
    • Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception
    • Male subjects must agree to practice contraception
    E.5 End points
    E.5.1Primary end point(s)
    Primary end-points:
    • Comparison of time to progression (TTP) after first high-dose melphalan with stem cell support (HDT) and TTP after a second HDT combined with carfilzomib-cyclophosphamide-dexamethasone (CAR-CY-DEX).
    • Comparison of TTP between carfilzomib-dexamethasone maintenance and observation in patients treated with a second HDT.

    E.5.1.1Timepoint(s) of evaluation of this end point
    After induction treatment, two months after highdose therapy and after maintenance therapy
    E.5.2Secondary end point(s)
    Secondary end-points:
    • Toxicity of CAR-CY-DEX as induction regime and carfil-zomib as part of the high-dose melphalan conditioning
    • Response rates of induction therapy and HDT
    • Time to marrow regeneration (neutrophil- and platelet recov-ery) after the HDT
    • Toxicity of maintenance treatment with carfilzomib-dexamethasone
    • Comparison of overall survival between carfilzomib-dexamethasone maintenance and observation in patients treated with a second HDT • Quality of life
    E.5.2.1Timepoint(s) of evaluation of this end point
    After induction treatment, two months after highdose therapy and after maintenance therapy
    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 No
    E.6.5Efficacy No
    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. trial type description
    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 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. description
    observation without treatment
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Nordic Myeloma Study Group
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusOngoing
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