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    The EU Clinical Trials Register currently displays   43931   clinical trials with a EudraCT protocol, of which   7307   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-001178-13
    Sponsor's Protocol Code Number:NMSG#24/15
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-07-18
    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 ConcernedSweden - MPA
    A.2EudraCT number2016-001178-13
    A.3Full title of the trial
    Phase 2 study of carfilzomib + elotuzumab + dexamethasone for relapsed or progressed multiple myeloma after 1-3 prior treatment lines
    Fas 2-studie med carfilzomib + elotuzumab + dexametason för behandling av myelom vid återfall eller progress efter 1 till 3 tidigare behandlingslinjer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 study of carfilzomib + elotuzumab + dexamethasone for relapsed or progressed multiple myeloma after 1-3 prior treatment lines
    A.4.1Sponsor's protocol code numberNMSG#24/15
    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 SponsorHelsinki University Central Hospital
    B.1.3.4CountryFinland
    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 supportHelsinki University Central Hospital
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelsinki University Central Hospital
    B.5.2Functional name of contact pointRaija Silvennoinen
    B.5.3 Address:
    B.5.3.1Street AddressHaartmaninkatu 4, Kolmiosairaala 7th floor
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post code00029
    B.5.3.4CountryFinland
    B.5.4Telephone number358503276348
    B.5.5Fax number358947172351
    B.5.6E-mailraija.silvennoinen@helsinki.fi
    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 Kyprolis
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/08/548
    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 INNCarfilsomib
    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 number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 No
    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 Empliciti
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 concentrate 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 INNElotuzumab
    D.3.9.3Other descriptive nameELOTUZUMAB
    D.3.9.4EV Substance CodeSUB121695
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 No
    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.2.5The 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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXAMETHASONE
    D.3.9.3Other descriptive nameDexamethasone
    D.3.9.4EV Substance CodeSUB07017MIG
    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 No
    D.IMP: 4
    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 Empliciti (400 mg)
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameElotuzumab
    D.3.2Product code BMS-901608
    D.3.4Pharmaceutical form Powder for concentrate 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 INNElotuzumab
    D.3.9.2Current sponsor codeBMS-901608
    D.3.9.3Other descriptive nameHuLuc63
    D.3.9.4EV Substance CodeSUB121695
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 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] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    To investigate the safety and feasibility of carfilzomib + elotuzumab +
    dexamethasone combination and initial efficacy in relapsed or progressed multiple myeloma patients.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients at the age of 18 to below 75 years with the life
    expectancy of at least three months.
    2. Prior confirmed diagnosis of multiple myeloma and measurable disease in
    blood or urine with at least one of the following: Serum M-protein ≥ 5g/l,
    Urine M-protein ≥ 200 mg/24 hours, In subjects without detectable serum
    or urine M-component, serum free light chain (S-FLC) > 100 ml/l
    (involved light chain) and an abnormal serum kappa/lambda ratio
    3. Relapse or progression after 1 to 3 prior treatment lines, which have
    included proteasome inhibitors (PI, bortezomib and/or ixazomib) and/or
    lenalidomide. Refractoriness to PI´s and/or lenalidomide is allowed in the
    preceding cycle. Patients must be carfilzomib naíve. Patients with
    previous autologous transplantation can be included.
    4. Need of treatment of relapse or progression: IMWG criteria for
    relapse/progression (paraprotein or CRAB criteria or both). (Appendix 5)
    5. Voluntary written consent must be given before performance of any study
    related procedure not part of standard medical care, with the
    understanding that the patient may withdraw consent at any time without
    prejudice to future medical care.
    6. Females of childbearing potential (FCBP) must have a confirmed negative
    serum pregnancy test within the 7 days prior to inclusion
    7. Females of childbearing potential must use one effective method of
    contraception and their partners condom during the study and for 120 days
    following the last study drug treatment dose and male subjects who are
    sexually active with FCBP must agree to use condom during the study and
    for 180 days following the last study drug treatment dose.
    8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2, or
    Karnofsky at least 60. (Appendix 1)
    9. Patients must meet the following adequate organ and bone marrow
    function within 21 days prior to inclusion:
    • Absolute neutrophil count (ANC) 1,000/mm3 (≥ 1.0 x 109/L) and
    platelet count 75 x 109/L. Platelet transfusions to help patients
    meet eligibility criteria are not allowed within 3 days before study
    enrollment. Granulocyte growth factors are allowed to meet the
    inclusion criteria?
    • Hemoglobin (Hb) ≥ 80 g/l (use of erythropoietin and red blood cell
    transfusions allowed by institutional guidelines, however the most
    recent RBC may not have given within 7 days prior to obtaining
    screening Hb
    • Total bilirubin < 1.5 times the upper limit of the normal range (ULN).
    • Alanine aminotransferase (ALT) and aspartate aminotransferase
    (AST) < 3 times the ULN.
    • Calculated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault
    estimation of creatinine clearance (CRcl): CRcl (mL/min) = (140 -
    age) x (weight [kg]) / 72 x (serum creatinine [mg/dL]); for females,
    multiply by 0.85 (Cockcroft DW. 1976, Luke DR. 1990)(Appendix 2).
    10. Patient must be willing and able to adhere to the study protocol visit
    schedule and other protocol requirements.
    11. Negative pregnancy test at inclusion if applicable
    E.4Principal exclusion criteria
    1. Female patients who are lactating or have a positive serum pregnancy
    test during the screening period.
    2. Major surgery within 28 days before enrollment.
    3. Radiotherapy within 14 days before enrollment, but if the involved field
    is small, 7 days will be considered a sufficient interval before onset of
    the treatment.
    4. Glucocorticoid therapy within the 14 days prior to inclusion that
    exceeds a cumulative dose of 160 mg dexamethasone or 1000 mg
    prednisone.
    5. Central nervous system involvement.
    6. Infection requiring systemic antibiotic therapy or other serious infection
    within 14 days before study enrollment.
    7. Active congestive heart failure (NYHA III-IV) (Appendix 3),
    symptomatic ischemia, conduction abnormalities uncontrolled by
    conventional intervention, acute diffuse infiltrative pulmonary disease,
    pericardial disease or myocardial infarction within 6 months prior to
    enrollment or left ventricular ejection fraction (LVEF) <40% within one
    month before randomization.
    8. Ongoing or active systemic infection, active hepatitis A, B or C virus
    infection, or known human immunodeficiency virus (HIV) positivity.
    9. Any other serious medical or psychiatric illness that could, in the
    investigator’s opinion, potentially interfere with the completion of
    treatment according to this protocol.
    10. Known allergy to Captisol (a cyclodextrin derivative used to solubilize
    carfilzomib) or to any of the study medications, their analogues, or
    excipients in the various formulations of any agent.
    11. Contraindication to dexamethasone or any of the required concomitant
    drugs or supportive treatments, including hypersensitivity to antiviral
    drugs, or intolerance to hydration due to pre-existing pulmonary or
    cardiac impairment.
    12. Diagnosed or treated for another malignancy within 5 years before study
    enrollment or previously diagnosed with another malignancy and have
    any evidence of residual disease. Patients with nonmelanoma skin
    cancer or carcinoma in situ of any type are not excluded if they have
    undergone complete resection.
    13. Patient has ≥ Grade 3 peripheral neuropathy, or Grade 2 with pain on
    clinical examination within the 14 days prior to inclusion.
    14. Participation in another interventional study within the 28 days before
    this study inclusion.
    15. Patients that have been previously treated with elotuzumab or
    carfilzomib.
    16. Primary plasma cell leukemia, systemic AL amyloidosis, Waldenström
    macroglobulinemia, rare IgM multiple myeloma, POEMS syndrome,
    myelodysplasia
    17. Allogeneic or autologous stem cell transplantation planned
    18. Participants receiving any other investigational agents or received
    within 60 days
    19. Pleural effusions requiring thoracocentesis within the 14 days prior the
    inclusion.
    20. Ascites requiring ascitespunction within the 14 days prior to inclusion.
    21. Previous allogeneic transplantation
    22. Uncontrolled hypertension or uncontrolled diabetes despite medication
    23. Known hepatic cirrhosis
    24. Severe autoimmune disease
    25. Positive direct antiglobulin test (DAT), Coombs test
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR) with carfilzomib + elotuzumab + dexamethasone
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint (ORR) together with the relevant secondary
    endpoints will be assessed after the minimum follow-up of one year
    has been reached with the last included patient.
    E.5.2Secondary end point(s)
    • Complete response rate (CR)
    • Quality of response (proportion of minimal residual disease (MRD) negativity in patients
    with at least VGPR response)
    • Duration of responses
    • Progression-free survival (PFS)
    • Time to next treatment (TTNT)
    • Safety (Adverse events)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Primary endpoint (ORR) together with the relevant secondary
    endpoints will be assessed after the minimum follow-up of one year
    has been reached with the last included patient.
    To assess PFS and TTNT all patients will be followed until 4 years
    after first dose.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    The patients are followed (PFS and TTNT) are followed until 4 years after first dose (two years after LPFV). All patients are followed 2 years after end of treatment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    None
    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 Decision2018-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-20
    P. End of Trial
    P.End of Trial StatusOngoing
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