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    Summary
    EudraCT Number:2006-004247-29
    Sponsor's Protocol Code Number:AMD3100-EU23
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-11
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-004247-29
    A.3Full title of the trial
    A Multicenter, Randomized, Comparative, Patient-blinded Study to Evaluate the Safety and Efficacy of G-CSF Alone Versus AMD3100 (240 µg/kg) Added to a G-CSF Mobilization Regimen in Adult Patients with Non-Hodgkin’s Lymphoma (NHL), Hodgkin’s Disease (HD) or Multiple Myeloma (MM) Who Have Previously Failed Stem Cell Collections.
    A.4.1Sponsor's protocol code numberAMD3100-EU23
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGenzyme Europe BV
    B.1.3.4CountryNetherlands
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/04/227
    D.3 Description of the IMP
    D.3.1Product nameAMD3100
    D.3.2Product code AMD3100
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 codeAMD3100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Mobilization of stem cells prior to autologous stem cell transplantation in patients with multiple myeloma, non-Hodgkin's lympoma, and Hodgkin's disease.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10029547
    E.1.2Term Non-Hodgkin's lymphoma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020206
    E.1.2Term Hodgkin's disease
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if patients reach a target of >= 2x10E6 cells/kg within 2 days of apheresis in NHL, HD or MM patients who are documented poor mobilizers that have received a mobilization regimen of G-CSF with placebo or a mobilization regimen of G-CSF with AMD3100.
    E.2.2Secondary objectives of the trial
    1. To examine and compare the safety of both mobilization regimens, G-CSF plus AMD3100 (240 µg/kg) and G-CSF plus placebo in NHL, MM and HD patients.
    2. To measure the daily and total number of CD34+ cells harvested during apheresis.
    3. To measure the number of days of apheresis needed to harvest > 2x10E6 CD34+ cells/kg.
    4. To measure the number of days of apheresis needed to harvest > 5x10E6 CD34+ cells/kg.
    5. To determine the times of PLT and PMN engraftment
    6. To evaluate the durability of PLT and PLM engraftment
    7. To determine if patients reach the Optimum Target of >= 5x10E6 CD34+ cells/kg within 4 days of apheresis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 to 78 years.
    2. Eligible to undergo autologous transplantation.
    3. Diagnosis of NHL, HD or MM [patients with plasma cell leukemia or other leukemias, including chronic lymphocytic leukemia (CLL), are excluded].
    4. In the last collection attempt prior to entry into this trial, the patient has failed to collect 0.8X10E6 cells/kg in at least 2 apheresis sessions or 2X10E6 cells/kg in 4 apheresis sessions using a mobilization regimen of chemotherapy, with or without G-CSF.
    NOTE: The complete history of the failed collection and/or collection attempts, including the mobilization regimen, apheresis yield(s), and/or peripheral blood (PB) CD34+ cell count(s) will be documented and submitted to Genzyme prior to enrollment and randomization.
    5. A minimum of a 7-day interval between last collection attempt and randomization.
    6. Performance status, Eastern Cooperative Oncology Group (ECOG) of 0 or 1 (see Appendix E).
    7. Cardiac, pulmonary and renal function deemed clinically adequate to be able to undergo mobilization and transplant.
    8. =/> 21 days between the last cycle of chemotherapy (e.g. cyclophosphamide) and randomization (thalidomide, dexamethasone, and other corticosteroids, Rituxan and Velcade are not considered prior chemotherapy for the purpose of this study).
    9. The patient has recovered from all acute toxic effects of prior chemotherapy.
    10. WBC > 2.5X10E9/l.
    11. Absolute neutrophil count >1.5X10E9/l.
    12. Platelet count > 75X10E9/l.
    13. Adequate renal function as demonstrated by serum creatinine </=2.2 mg/dl or creatinine clearance (24 hr urine collection) > 60 ml/min.
    14. Serum Glutamate Oxaloacetate Transaminase (SGOT), Serum Glutamate Pyruvate Transaminase (SGPT) and total bilirubin < 2.5 X upper limit of normal (ULN).
    15. No active Hepatitis A, B or C infection.
    16. Signed informed consent.
    17. All patients must agree to use a highly effective method of contraception (including both female patients of child-bearing potential and male patients with child-bearing potential partners). Effective birth control includes: a) birth control pills, depot progesterone, or an IUD 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 AMD3100 with hormonal contraceptives is not known.
    E.4Principal exclusion criteria
    1. A co-morbid condition which, in the view of the Investigators, renders the patient at high risk from treatment complications.
    2. A residual acute medical condition resulting from prior chemotherapy.
    3. Received thalidomide, dexamethasone or corticosteroids, Rituxan and Velcade within 7 days prior to randomization.
    4. Brain metastases or carcinomatous meningitis.
    5. Active acute or chronic infection or anti-infective therapy within 7 days of randomization.
    6. Fever (temperature > 38°C).
    7. Hypercalcaemia (> 1 mg/dl above the ULN).
    8. Known to be HIV-positive.
    9. Pregnant and nursing females.
    10. Patient unwilling to implement adequate birth control (including both femalepatients of child-bearing potential and male patients with child-bearing potential partners).
    11. Patients who previously received experimental therapy within 4 weeks of randomization or who are currently enrolled in another experimental protocol during the Mobilization phase.
    12. Patients who have failed a previous collection attempt within 7 days or less from randomization.
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy of AMD3100 is demonstrated by the ability to mobilize and collect stem cells. The primary efficacy endpoint is the binary response variable categorizing whether the patient was able to mobilize a minimum of at least 2x10E6 CD34+ cells/kg within 2 days of apheresis.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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 Yes
    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 concerned5
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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
    Last follow-up visit of the last patient undergoing the trial
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state5
    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 Decision2007-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-06-23
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