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    Summary
    EudraCT Number:2011-004783-30
    Sponsor's Protocol Code Number:ARD12858-MOZ23510
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-15
    Trial results View 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 ConcernedEstonia - SAM
    A.2EudraCT number2011-004783-30
    A.3Full title of the trial
    A pilot, exploratory, randomized, phase 2 safety study evaluating tumor cell (plasma cell) mobilization and apheresis product contamination in plerixafor plus non-pegylated G-CSF mobilized patients and in non-pegylated G-CSF alone mobilized patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Exploratory Safety Study to Investigate the Extent of Tumor Cell Mobilization (TCM) After Use of G-CSF Alone or G-CSF Plus Plerixafor in Multiple Myeloma (MM) Patients Who May be Poor Mobilizers of Stem Cells
    A.4.1Sponsor's protocol code numberARD12858-MOZ23510
    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 SponsorSanofi aventis recherche et développement
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi aventis recherche et développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis Estonia OÜ
    B.5.2Functional name of contact pointClinical Study Unit
    B.5.3 Address:
    B.5.3.1Street AddressPärnu mnt 139E/2
    B.5.3.2Town/ cityTallinn
    B.5.3.3Post code11317
    B.5.3.4CountryEstonia
    B.5.4Telephone number+372 627 3496
    B.5.5Fax number+372 627 3491
    B.5.6E-mailclinicaltrialsinfo_ee@sanofi-aventis.com
    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 20 mg/ml solution for injection
    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/3/04/227
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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.3.9.2Current sponsor codeGZ316455
    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
    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 17.0
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate tumor cell mobilization (TCM) with non-pegylated G-CSF alone compared with non pegylated G-CSF plus plerixafor in patients with multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC).
    E.2.2Secondary objectives of the trial
    To evaluate survival and disease status of G-CSF alone compared with GCSF plus plerixafor.
    To evaluate the efficacy and safety of G-CSF plus plerixafor when used to mobilize stem cells for autologous transplantation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with a diagnosis of MM in partial or complete response, who are to undergo an autologous HSCT and could be considered potentially poor mobilizers.
    A potentially poor mobilizer is defined as a person who, in the judgment of the investigator prior to study entry, may not mobilize successfully for reasons such as prior lenalidomide use.
    E.4Principal exclusion criteria
    The patient does not have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
    The patient has a history of any acute or chronic leukemia (including myelodysplastic syndrome).
    The patient had prior allogeneic or autologous transplantation.
    The patient is less than 3 to 6 weeks since last anti-cancer therapy.
    Chemotherapy for mobilization is not allowed. Note: Treatment with thalidomide, dexamethasone, lenalidomide (Revlimid®), and/or bortezomib (Velcade®) is allowed up to 7 days prior to the first dose
    of G-CSF.
    The patient has bone marrow involvement >10% assessed based on the most recent bone marrow aspirate or biopsy performed prior to first dose of G-CSF.
    The patient was treated with G-CSF or other cytokine within 14 days prior to the first dose of GCSF
    for mobilization.
    The patient has previously received plerixafor.
    The patient is known to be HIV positive.
    The patient has active hepatitis B or hepatitis C.
    The patient has an acute infection (febrile, ie, temperature >38°C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of G-CSF.
    The patient has hypercalcaemia as evidenced by >1 mg/dL above ULN.
    The patient previously received investigational therapy within 4 weeks of screening in this protocol or currently enrolled in another investigational protocol during the mobilization phase.
    The patient has central nervous system involvement including brain metastases or leptomeningeal disease.
    The patient has an electrocardiogram (ECG) or study result (exercise study, scan) indicative of cardiac ischemia or a history of clinically significant rhythm disturbance (arrhythmias), or other
    conduction abnormality in the last year that in the opinion of the investigator warrants exclusion of the subject from the trial.
    The patient has co-morbid condition(s), which in the opinion of the investigator, renders the patient at high risk from treatment complications or impairs his/her ability to comply with the study treatment and protocol.
    The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study
    The patient has a white blood cell (WBC) count <2.5 x _109/L.
    The patient has an absolute neutrophil count (ANC) <1.5 x _109/L.
    The patient has a platelet count <100 x 109/L.
    The patient has an estimated creatine clearance ≤50 mL/min.
    The patient has aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT), and total bilirubin ≥2.5 x _upper limit of normal (ULN).
    The patient does not have adequate cardiac, and pulmonary function sufficient to undergo apheresis and transplantation, ie, eligible by institutional standards for autologous stem cell
    transplant.
    Pregnant or breastfeeding women
    The patient does not agree to use a highly effective method of contraception while on study treatment and for at least 3 months following study treatment (including both female patients of childbearing potential and male patients with partners of child-bearing potential). Effective birth control includes:
    a) birth control pills, depot progesterone, or an intrauterine device plus one barrier method, or
    b) two barrier methods. Effective barrier methods are: male and female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). For patients using a hormonal contraceptive method, information about any interaction of plerixafor with hormonal contraceptives is not known.
    E.5 End points
    E.5.1Primary end point(s)
    Peripheral blood parameters:
    1. The percentage of myeloma tumor cells/CD34+ cells
    2. The percentage of myeloma tumor cells/plerixafor cumulative dose/kg body weights
    3. The percentage of myeloma tumor cells/G-CSF cumulative dose/kg body weight
    4.The change in TCM in the peripheral blood
    Apheresis product parameters:
    5. The number/volume of myeloma tumor cells per patient at each apheresis
    6. The proportion of patients who mobilize at least 4.5x105 myeloma tumor cells/kg body weight as measured in each apheresis product
    E.5.1.1Timepoint(s) of evaluation of this end point
    Peripheral blood parameters:

    Variable Day 1 to Day 8 of the Apheresis/Treatment Period :
    1. The percentage of myeloma tumor cells/CD34+ cells
    5. The number/volume of myeloma tumor cells per patient at each apheresis

    Variable Day 5 to Day 8 of the Apheresis/Treatment Period :
    2. The percentage of myeloma tumor cells/plerixafor cumulative dose/kg body weights
    3. The percentage of myeloma tumor cells/G-CSF cumulative dose/kg body weight
    6. The proportion of patients who mobilize at least 4.5x105 myeloma tumor cells/kg body weight as measured in each apheresis product

    Up to Day 5 pre-G-CSF Apheresis product parameters:
    4.The change in TCM in the peripheral blood
    E.5.2Secondary end point(s)
    - CD34+ stem cell yield in the apheresis product
    - The proportion of patients that proceed to transplantation
    - Overall survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    - CD34+ stem cell yield in the apheresis product : Variable Day 1 to Day 8 of the Apheresis/Treatment Period
    - The proportion of patients that proceed to transplantation : Up to two months after final apheresis
    - Overall survival : At day 100 post transplant and up to 2 years post first G-CSF 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 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 No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA20
    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 years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days15
    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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state8
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-28
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