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    Summary
    EudraCT Number:2021-000987-31
    Sponsor's Protocol Code Number:35RC17_8825_IMMUNO-MYELO
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-03-15
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-000987-31
    A.3Full title of the trial
    Immunomonitoring and multiple myeloma: impact of lenalidomide on immune checkpoint expression
    Immunomonitoring et myélome multiple: impact du lénalidomide sur l'expression des immune checkpoint
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of lenalidomide on immune cell expression in multiple myeloma
    Impact du lénalidomide sur l'expression des cellules immunitaires dans le myélome multiple
    A.3.2Name or abbreviated title of the trial where available
    IMMUNO-MYELO
    A.4.1Sponsor's protocol code number35RC17_8825_IMMUNO-MYELO
    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 SponsorCHU Rennes
    B.1.3.4CountryFrance
    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 supportCelgene International II, sarl
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportFrench-speaking Myeloma Intergroup
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Rennes
    B.5.2Functional name of contact pointHaematology
    B.5.3 Address:
    B.5.3.1Street Address2 avenue Henri Le Guilloux
    B.5.3.2Town/ cityRennes
    B.5.3.4CountryFrance
    B.5.4Telephone number+33299284321
    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 Revlimid
    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 nameRevlimid
    D.3.4Pharmaceutical form Capsule
    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 INNLENALIDOMIDE
    D.3.9.1CAS number 191732-72-6
    D.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Multiple Myeloma
    Myélome multiple
    E.1.1.1Medical condition in easily understood language
    Multiple Myeloma
    Myélome multiple
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    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
    To assess the activation of medullary lymphocytes after a lenalidomide-dexamethasone cycle in patients with newly diagnosed multiple myeloma.
    Evaluer l’activation des lymphocytes médullaires après un cycle de lénalidomide-dexaméthasone chez des patients atteints de myélome multiple nouvellement diagnostiqué.
    E.2.2Secondary objectives of the trial
    *Characterize the phenotypic modulations of the immune subpopulations induced by Lenalidomide in the marrow of multiple myeloma patients.
    *Characterize the phenotypic modulations of lenalidomide induced tumor plasma cells in the marrow of multiple myeloma patients.
    *Identify biomarkers in circulating blood to assess the impact of new therapies on the immune response.
    *Caractériser les modulations phénotypiques des sous-populations immunitaires induites par le Lénalidomide dans la moelle des patients atteints de myélome multiple.
    *Caractériser les modulations phénotypiques des plasmocytes tumoraux induites par le Lénalidomide dans la moelle des patients atteints de myélome multiple.
    *Identifier des biomarqueurs présents dans le sang circulant et permettant d’évaluer l'impact des nouvelles thérapeutiques sur la réponse immunitaire.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient with newly diagnosed multiple myeloma;
    - Patient not eligible for intensive treatment;
    - Patient for whom first-line treatment with Lenalidomide-Dexamethasone will be initiated;
    - Patient accepting the performance of an additional myelogram at the end of the 1st treatment cycle.
    - Patient aged 18 years or older;
    - Patient who has given free, informed and written consent;
    - Patient affiliated to a social security scheme
    - For women of childbearing age, use of effective contraception
    - Patient atteint d’un myélome multiple nouvellement diagnostiqué ;
    - Patient non éligible à un traitement intensif ;
    - Patient pour lequel un traitement de première ligne par Lénalidomide-Dexaméthasone va être initié ;
    - Patient acceptant la réalisation d’un myélogramme supplémentaire à la fin du 1er cycle de traitement.
    - Patient âgé de 18 ans ou plus ;
    - Patient ayant donné un consentement libre, éclairé et par écrit ;
    - Patient affilié à un régime de sécurité sociale
    - Pour les femmes en âge de procréer, utilisation d’une contraception efficace
    E.4Principal exclusion criteria
    - Patient with relapsed multiple myeloma;
    - Patient eligible for intensive treatment;
    - Patient for whom chemotherapy involves treatment other than Lenalidomide-Dexamethasone;
    - Patient with a contraindication to lenalidomide treatment
    - Pregnant or breastfeeding woman;
    - Person subject to legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty.
    - Patient ayant un myélome multiple en rechute ;
    - Patient éligible à un traitement intensif ;
    - Patient pour lequel la chimiothérapie comporte d’autre traitement que l’association Lénalidomide-Dexaméthasone ;
    - Patient présentant une contre-indication au traitement par lénalidomide
    - Femme enceinte ou allaitante ;
    - Personne faisant l'objet d'une protection légale (sauvegarde de justice, curatelle, tutelle) ou personne privée de liberté.
    E.5 End points
    E.5.1Primary end point(s)
    Increased expression of HLA-DR on medullary T-lymphocytes after exposure to lenalidomide-dexamethasone.
    Augmentation de l’expression de HLA-DR sur les lymphocytes T médullaires après exposition au lénalidomide-dexaméthasone.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    28 jours
    E.5.2Secondary end point(s)
    *Assessment of the expression of activation/maturation markers and immune checkpoints by medullary immune cell subpopulations.
    *Assessment of the expression of activation/maturation markers and immune checkpoints by medullary tumour plasma cells.
    *Assessment of the expression of activation/maturation markers and immune checkpoints by blood immune cell subpopulations.
    *Evaluation de l’expression des marqueurs d’activation/maturation et des immune checkpoints par les sous-populations cellulaires immunitaires médullaires.
    *Evaluation de l’expression des marqueurs d’activation/maturation et des immune checkpoints par les plasmocytes tumoraux médullaires.
    *Evaluation de l’expression des marqueurs d’activation/maturation et des immune checkpoints par les sous-populations cellulaires immunitaires sanguines.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days
    28 jours
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 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
    LVLS
    LVLP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    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: 2
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state22
    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 Decision2021-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-12-13
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