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    Summary
    EudraCT Number:2016-002557-38
    Sponsor's Protocol Code Number:Allo-MM-PostCy-Study
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-10-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-002557-38
    A.3Full title of the trial
    Cyclophosphamide as graft-versus-host prophylaxis after allogeneic stem cell
    transplantation for multiple myeloma. A phase II study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cyclophosphamide as graft-versus-host prophylaxis after allogeneic stem cell
    transplantation for multiple myeloma. A phase II study.
    Cyclophosphamid zur Prophylaxe (Vorbeugung) der SPENDER-GEGEN-EMPFÄNGER-REAKTION nach allogener Stammzelltransplantation bei Patienten mit Multiplen Myelom
    A.4.1Sponsor's protocol code numberAllo-MM-PostCy-Study
    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 SponsorUniversity Medical Center Hamburg-Eppendorf
    B.1.3.4CountryGermany
    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 supportUniversity Medical Center Hamburg-Eppendorf
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportRiemser
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Stem Cell Transplantation University Medical Center Hamburg-Eppendorf
    B.5.2Functional name of contact pointStudy Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressMartinistrasse 52
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20246
    B.5.3.4CountryGermany
    B.5.4Telephone number0049407410-54851
    B.5.5Fax number0049407410-53795
    B.5.6E-mailnkroeger@uke.de
    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 Cyclophosphamid Trockensubstanz
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Oncology
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Powder for dispersion for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    Multiple myeloma
    Multiples Myelom
    E.1.1.1Medical condition in easily understood language
    Plasma cell myeloma; cancer of the blood-forming system
    Plasmozytom; Krebserkrankung des blutbildenden Systems
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000054086
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary endpoint of the study is chronic GvHD and progression-free
    survival at 2 years after transplantation.
    Das primäre Studienziel ist die chronische GvHD und das progressionsfreie Überleben 2 Jahre nach allogener Stammzelltransplantation
    E.2.2Secondary objectives of the trial
    - to evaluate the incidence of acute and chronic graft-versus-host disease at 2-years, the 2-year risk of non-relapse mortality, the 2-year progressive-free, and overall survival in patients who received a toxicity-reduced conditioning regimen combined of thiotepa and busulfan followed by allogeneic stem cell transplantation from matched or mismatched, related or unrelated donor,and cyclophosphamide as post-transplant GvHD prophylaxis

    - to determine toxicity and safety of cyclophosphamide as GvHD prophylaxis
    • Inzidenz einer akuten und chronischen GvHD nach 2 Jahren, Nicht-rezidiv bedingte Sterblichkeit nach 2 Jahren, progressionsfreies Überleben nach 2 Jahren und Gesamtüberleben bei Patienten, welche eine dosisreduzierte Konditionierung (Thiotepa und Busul-fan) vor einer allogenen Stammzelltransplantation (passender oder nichtpassender Familien- bzw. Fremdspender) und Cyclophosphamide als GvHD Prophylaxe nach der Stammzelltransplantation erhal-ten haben
    • Erfassen von Toxizität und Sicherheit von Cyclo-phosphamid als GvHD Prophylaxe
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Multiple myeloma newly diagnosed with deletion 17p or translocation
    4;14 or multiple myeloma with 1. or 2. relapse after autologous
    stem cell transplantation
    - Patients age: 18 - 65 years at time of inclusion (female and
    male)
    -Performance status ECOG < 2
    - Availability of haploidentical, matched or mismatched relative or
    unrelated donor
    - Patients understand and voluntarily sign an informed consent
    1. Neu diagnostiziertes Multiples Myelom mit Deletion 17p oder Translokation 4;14 oder Multiples Myelom im 1. oder 2. Rezidiv nach einer autologen Stamm-zelltransplantation
    2. Männer und Frauen zwischen 18 und 65 Jahren zum Zeitpunkt des Einschlusses
    3. ECOG-Leistungsstatus von ≤ 2
    4. Vorhandensein von einem haploidenten, passenden oder nicht passenden Familien - bzw. Fremdspender
    5. Fähigkeit des Patienten die Patienteninformation in-haltlich zu verstehen und die Einwilligungserklärung eigenständig und freiwillig zu unterschreiben.
    E.4Principal exclusion criteria
    -Multiple Myeloma newly diagnosed patients without detection of deletion 17p or translocation 4;14
    -Severe active infection or other uncontrolled severe condition-ing
    -Severe renal, hepatic, pulmonary or cardiac disease, such as:
    • Total bilirubin, SGPT or SGOT > 3 times upper the normal level
    • Left ventricular ejection fraction < 30 %
    • Creatinine clearance < 30 ml/min
    • DLCO < 35 % and/or receiving supplementary continuous ox-ygen
    -Positive serology for HIV
    -Pregnant or lactating women (positive serum pregnancy test)
    - Age < 18 and > 65 years.
    - Uncontrolled invasive fungal infection at time of screening (baseline)
    - Serious psychiatric or psychological disorders
    - Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment
    1. Neu diagnostiziertes Multiples Myelom ohne Deletion 17p oder Translokation 4;14
    2. Schwere aktive Infektionen oder andere unkontrol-lierte schwere Erkrankungen
    3. Schwere renale, hepatische, pulmonale oder kardiale Erkrankungen, wie z. B.
    • Total Bilirubin, SGPT oder SGOT > 3 x des oberen Normwertes
    • Linksventrikuläre Ejektionsfraktion < 30 %
    • Kreatinin Clearance < 30 ml/min
    • DLCO < 35 % und/oder ständige Sauerstoffzufuhr
    4. HIV – Positivität (Serologie)
    5. Schwangere oder stillende Frauen (positiver Serum Schwangerschaftstest)
    6. Patientenalter < 18 und > 65 Jahre zum Zeitpunkt des Einschlusses
    7. Unkontrollierte invasive Pilzinfektion zum Zeitpunkt des Screening (Baseline)
    8. Schwere psychiatrische oder psychologische Er-krankungen
    9. Teilnahme an einer anderen klinischen Studie mit ei-nem nichtzugelassenem Prüfpräparat 28 Tage vor Studieneinschluss
    E.5 End points
    E.5.1Primary end point(s)
    Chronic GvHD and progression-free survival at 2 years after allogeneic SCT
    chronische GvHD und das progressionsfreie Überleben 2 Jahre nach allogener Stammzelltransplantation
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years after allogeneic SCT
    2 Jahre nach allogener Stammzelltransplantation
    E.5.2Secondary end point(s)
    1. NRM at 2 years after allogeneic SCT
    2. Incidence of acute GvHD on Day +100 after allogeneic SCT
    3. Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT
    4. Toxicity according to NCI
    5. Complete remission rate (including sCR and MRD negativity)
    6. Overall and progression-free survival at 2 years
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. NRM at 2 years after allogeneic SCT
    2. Incidence of acute GvHD on Day +100 after allogeneic SCT
    3. Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT
    4. Toxicity according to NCI
    5. Complete remission rate (including sCR and MRD negativity)
    6. Overall and progression-free survival at 2 years
    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) 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.8.2.4Number of treatment arms in the trial1
    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
    LVLS
    Letzte Nachuntersuchung des letzten Patienten
    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: 50
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state50
    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 Decision2018-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-04
    P. End of Trial
    P.End of Trial StatusOngoing
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