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    Summary
    EudraCT Number:2016-004122-41
    Sponsor's Protocol Code Number:1
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-02
    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 ConcernedAustria - BASG
    A.2EudraCT number2016-004122-41
    A.3Full title of the trial
    Plerixafor for stem cell mobilization in patients with multiple myeloma who mobilize moderate to optimize collection results - a randomized, placebo-controlled, double-blind study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Plerixafor for stem cell mobilization in patients with Multiple Myeloma to optimize collection results
    A.3.2Name or abbreviated title of the trial where available
    Plerixafor for moderate mobilizing myeloma patients
    A.4.1Sponsor's protocol code number1
    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 SponsorMedical University Vienna, Dept. f. Transfusion Medicine
    B.1.3.4CountryAustria
    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 supportSanofi-Aventis GmbH Österreich
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University Vienna, Dept. f. Transfusion Medicine
    B.5.2Functional name of contact pointOffice
    B.5.3 Address:
    B.5.3.1Street AddressWaehringer Guertel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+4314040053080
    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 Mozobil
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme 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/3/04/277
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPlerixafor
    D.3.9.1CAS number 110078-46-1
    D.3.9.3Other descriptive namePLERIXAFOR
    D.3.9.4EV Substance CodeSUB28849
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Stem cell mobilization with mozobil (plerixafor) in patients with multiple myeloma.
    E.1.1.1Medical condition in easily understood language
    Evaluation of the benefit of mozobil (plerixafor) induced stem cell mobilization.
    E.1.1.2Therapeutic area Body processes [G] - Cell Physiological Phenomena [G04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate efficacy of plerixafor in patients with multiple myeloma in comparison to G-CSF alone for stem cell mobilization, as measured by stem cell harvest results sufficient for tandem-transplantation in only one collection.
    E.2.2Secondary objectives of the trial
    To assess safety and tolerability of plerixafor in patients with multiple myeloma
    To assess effect of plerixafor on collection efficiency (CE1 and CE2)
    To assess differences in composition of stem cell grafts between patients with and without plerixafor treatment
    To assess differences in hematopoietic recovery, sustained engraftment an immunologic recovery after autologous transplantation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18 to ≤75 years.
    Patients with MM in whom for at least two HSCTs cells have to be collected.
    After steady state mobilization with G-CSF alone: if ≥20/µL and ≤40/µL CD34+ cells in the PB on day 4 of G-CSF administration.
    Written informed consent.
    Female patients must be one of the following: postmenopausal, surgically incapable of bearing children, practicing an acceptable method of birth control (effective contraception) during treatment and up to a minimum of 3 months after the last dose of treatment. If a female patient is of childbearing potential, she must have a negative pregnancy test prior to study entry and in monthly intervals up to 3 months thereafter.
    Patients must be able and willing to comply with all study procedures.
    Renal impairment: dosage adjustment in patients with CrCl ≤50 mL/min is recommended. Patients with moderate and severe renal insufficiency (CrCl ≤50 mL/min) should have their dose of plerixafor reduced by one-third to 0.16 mg/kg.
    E.4Principal exclusion criteria
    Acute and chronic leukemia.
    Myelodysplastic syndrome.
    Malignant lymphoma.
    Any active infection including Hepatitis B or C.
    HIV positivity.
    Fever>38.5C, or if >37 and <38.5, infection must be excluded.
    CBC abnormalities: ANC<0.75x109/L, Platelets<50x109/LCD34+ cell <20/µL or >40/µL in the PB on day 4 of G-CSF administration.
    Chemomobilization.
    Liver Function Test abnormalities: LFT>3x ULN (AST, ALT, T-Bil)
    History of clinically significant cardiac abnormality or arrhythmia
    Pregnant or breast feeding patients.
    Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of SmPC
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients who achieve ≥6.0x10E6 CD34+ cells/kg in 1 apheresis for a planned double autologous HSCT
    E.5.1.1Timepoint(s) of evaluation of this end point
    On the day of apheresis after end of stem cell collection (=one day after administration of the IMP).
    E.5.2Secondary end point(s)
    Percentage of patients who achieve 9.0x10E6 CD34+ cells/kg in 1 apheresis for three autologous HSCTs.
    Documentation of side-effects of plerixafor.
    Composition of leukapheresis product (all analysis performed at the CCRI Vienna).
    Collection efficiency (CE1 and CE2).
    Haematopoietic engraftment defined as absolute neutrophil counts above 0.5x10E9/L and platelet counts above 20x10E9/L without further transfusion requirements for first and second HSCT.
    Blood and differential counts at day 15, 28 and 3 and 6 months after HSCT (onsite).
    Assessment of immune reconstitution by analysis of CD3+, CD4+ and CD8+ cells and their cellular subsets, NK, DC, and B-cells in PB by flow cytometry at day 15, 28, and 3 and 6 months after HSCT.
    E.5.2.1Timepoint(s) of evaluation of this end point
    On the day of apheresis after end of stem cell collection and on day 15, 28 and 3 and 6 months after autologous transplantation.
    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 Yes
    E.6.13.1Other scope of the trial description
    Composition of stem cell grafts.
    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 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.8.2.3.1Comparator description
    IMP against no additional 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 concerned2
    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
    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
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state120
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 120
    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 Decision2017-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-28
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