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    Summary
    EudraCT Number:2013-000795-15
    Sponsor's Protocol Code Number:MYVAC2
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-05
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-000795-15
    A.3Full title of the trial
    An open-label pilot clinical trial of MAGE-A3 and MAGE-C1 mRNA electroporated autologous dendritic cell vaccination in combination with lenalidomide maintenance therapy for multiple myeloma after first-line autologous stem cell transplantation.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label pilot clinical trial of MAGE-A3 and MAGE-C1 mRNA electroporated autologous dendritic cell vaccination in combination with lenalidomide maintenance therapy for multiple myeloma after first-line autologous stem cell transplantation.
    A.3.2Name or abbreviated title of the trial where available
    MYVAC2
    A.4.1Sponsor's protocol code numberMYVAC2
    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 SponsorUZ Brussel
    B.1.3.4CountryBelgium
    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 supportUZ Brussel
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZ Brussel
    B.5.2Functional name of contact pointRik Schots, MD,Phd
    B.5.3 Address:
    B.5.3.1Street AddressLaarbeeklaan 101
    B.5.3.2Town/ cityJette
    B.5.3.3Post code1090
    B.5.3.4CountryBelgium
    B.5.4Telephone number3224776211
    B.5.5Fax number3224776210
    B.5.6E-mailrik.schots@uzbrussel.be
    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 nameTriMix-DC
    D.3.2Product code TriMix-DC
    D.3.4Pharmaceutical form Solution for injection/infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    Intravenous use
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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 REVLIMID 5 and 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LTD
    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/3/03/177
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.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
    Symptomatic Multiple Myeloma after first-line autologous stem cell transplantation
    E.1.1.1Medical condition in easily understood language
    Symptomatic Multiple Myeloma after first-line autologous stem cell transplantation
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    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
    Immunotherapy with autologous messenger RNA-electroporated monocyte derived dendritic cells in combination with lenalidomide maintenance will induce significant anti-tumor cellular immune responses in multiple myeloma patients achieving very good partial response or complete response after autologous stem cell transplantation. This will result in an improvement in response quality which will eventually lead to improved progression-free and overall survival.
    E.2.2Secondary objectives of the trial
    1.To demonstrate the in-vivo immunogenicity of autologous MAGE-A3 and MAGE-C1 mRNA-electroporated monocyte derived dendritic cell vaccinations in combination with lenalidomide maintenance as evaluated by :
    -Ex-vivo functional analysis including the demonstration of specific anti-MAGE-A3 and MAGE-C1 T cell immunoreactivity.
    -In-vivo delayed type hypersensitivity response assessment with MAGE-A3 and MAGE-C1 protein.
    2.To determine progression-free survival and overall survival (OS).
    3.Assessment of safety and toxicity of lenalidomide maintenance and dendritic cell vaccination.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For the standard primary treatment phase:
    1.Able and willing to give valid written informed consent (IC1) before additional blood and bone marrow samples are collected.
    2.Patients must have newly diagnosed symptomatic multiple myeloma.
    3.Measurable disease.
    4.Age at diagnosis : 18- 65 years.
    5.Eligible for autologous stem cell transplantation.
    6.Collection of adequate bone-marrow samples to construct patient-specific PCR probes for minimal residual disease analysis

    For leukapheresis:
    1.Able and willing to give valid written informed consent (IC2) before leukapheresis.
    2.Having reached at least partial remission after autolous stem cell transplantation.

    For the experimental treatment phase:
    1.Able and willing to give valid informed consent (IC3) before the start of the experimental treatment
    2.At least in complete remission or very good partial response after autologous stem cell transplantation with or without consolidation
    3.Eastern Cooperative Oncology Group performance status of 0 or 1
    E.4Principal exclusion criteria
    EXCLUSION CRITERIA FOR STANDARD TREATMENT PHASE
    Patients will be excluded for enrolment if they fulfil any of the following criteria:
    1.Multiple myeloma of IgM subtype
    2.POEMS syndrome
    3.Plasma cell leukaemia or circulating plasma cells > 2 x 10E9/L.
    4.Waldenstrom’s macroglobulinemia
    5.Patients with known amyloidosis
    6.HIV, HbsAg or hepatitis C serology positivity
    7.History of other malignancy (other than basal cell carcinoma and carcinoma of the cervix in situ)
    8.Significant neuropathy (grades 3 to 4, or grade 2 with pain) within 14 days prior to start standard treatment phase.
    9.Female patients who are pregnant or lactating.
    10.Any other clinically significant medical disease or psychiatric condition that, in the investigator’s opinion, may interfere with protocol adherence or a patient’s ability to give informed consent.

    EXCLUSION CRITERIA FOR EXPERIMENTAL TREATMENT PHASE
    1.Concomitant chemotherapy or other antimyeloma treatment
    2.Concomitant immunosuppressive drugs including glucocorticosteroids
    3.Any other clinically significant medical disease or psychiatric condition that, in the investigator’s opinion, may interfere with protocol adherence or a patient’s ability to give informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    To demonstrate a significant improvement in the response quality after dendritic cell vaccination in combination with lenalidomide maintenance. Improvement in response quality is defined as :
    -Achieving complete response after dendritic cells vaccination for patients in very good partial response before vaccination.
    -Achieving a minimal residual disease negative state after dendritic cell vaccination for patients with complete remission having minimal residual disease positive state before vaccination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuously during the conduct of the trial
    E.5.2Secondary end point(s)
    1.To demonstrate the in-vivo immunogenicity of autologous MAGE-A3 and MAGE-C1 mRNA-electroporated monocyte derived dendritic cell vaccinations in combination with lenalidomide maintenance as evaluated by :
    -Ex-vivo functional analysis including the demonstration of specific anti-MAGE-A3 and MAGE-C1 T cell immunoreactivity.
    -In-vivo delayed type hypersensitivity response assessment with MAGE-A3 and MAGE-C1 protein.
    2.To determine progression-free survival and overall survival (OS).
    3.Assessment of safety and toxicity of lenalidomide maintenance and dendritic cell vaccination.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Continuously during the conduct of the trial
    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) 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 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 concerned3
    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
    The end of the study will occur at the time point when the last patient included in the experimental phase of the study will be off study either due to progression or due to unacceptable toxicity or withdrawal of patient’s consent.
    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
    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: 20
    F.1.3Elderly (>=65 years) No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-09-17
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