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    Summary
    EudraCT Number:2007-003945-33
    Sponsor's Protocol Code Number:RV-MM-PI-280
    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:2008-07-29
    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 number2007-003945-33
    A.3Full title of the trial
    A randomised comparison of daily 25 mg versus 5 mg lenalidomide as maintenance therapy after high-dose therapy and autologous stem cell transplantation in patients with multiple myeloma.
    Randomisierter Vergleich von 25 mg versus 5 mg Lenalidomid als Erhaltungstherapie nach Hochdosistherapie und autologer Blutstammzelltransplantation bei Patienten mit Multiplen Myelom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised comparison of daily 25 mg versus 5 mg lenalidomide as maintenance therapy after high-dose therapy and autologous stem cell transplantation in patients with multiple myeloma.
    Randomisierter Vergleich von 25 mg versus 5 mg Lenalidomid als Erhaltungstherapie nach Hochdosistherapie und autologer Blutstammzelltransplantation bei Patienten mit Multiplen Myelom
    A.3.2Name or abbreviated title of the trial where available
    LenaMain
    A.4.1Sponsor's protocol code numberRV-MM-PI-280
    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 SponsorGesellschaft für Medizinische Innovation –Hämatologie und Onkologie mbH (GMIHO)
    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 supportFa. Celgene
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGesellschaft für Medizinische Innovation –Hämatologie und Onkologie mbH (GMIHO)
    B.5.2Functional name of contact pointCRA - Clinical Research Associate
    B.5.3 Address:
    B.5.3.1Street AddressAlte Jakobstraße 77
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10179
    B.5.3.4CountryGermany
    B.5.4Telephone number+4935125933280
    B.5.5Fax number+4935125933289
    B.5.6E-mailinfo@gmiho.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 Revlimid (5 mg)
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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/3/03/177
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    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 (10mg)
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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/3/03/177
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 3
    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 (25mg)
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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/3/03/177
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    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.3.10 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
    Patients with multiple myeloma
    Multiples Myelom
    E.1.1.1Medical condition in easily understood language
    multiple myeloma
    Multiples Myelom
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level HLT
    E.1.2Classification code 10028229
    E.1.2Term Multiple myelomas
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the event-free survival (EFS) of patients with multiple myeloma who receive two different dose levels (25 vs. 5 mg daily) of lenalidomide as maintenance therapy after first line high-dose therapy and autologous stem cell transplantation.
    - Wirksamkeit durch Evaluation des ereignisfreien Überlebens (Event-free Survival, EFS) zwischen Hochdosis (25 mg) und Niedrigdosisarm (5 mg)
    E.2.2Secondary objectives of the trial
    - Evaluate safety, tolerability, and feasibility during consolidation (25 mg) and maintenance (25mg vs. 5 mg) therapy with lenalidomide.
    - Evaluate the improvement of remission rates during consolidation therapy with lenalidomide and compare remissions rates during maintenance therapy with two doses of lenalidomide.
    - Evaluate the quality of life of patients during consolidation and maintenance therapy with lenalidomide.
    - Evaluation der Sicherheit, Verträglichkeit und Machbarkeit
    - Evaluation Verbesserung der Remissionrate (RR)
    - Evaluation des Gesamtüberlebens (OS)
    - Evaluation der Lebensqualität (QoL)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Understand and voluntarily sign an informed consent form.
    - Age 18-75 years at the time of signing the informed consent form.
    - Able to adhere to the study visit schedule and other protocol requirements.
    - Patients with multiple myeloma who have received high-dose therapy and autologous stem cell transplantation as first-line therapy within the last 90 – 120 days and have not shown progressive disease afterwards. Patients may have received a second high-dose therapy in case of less than a vgPR or due to conditioning with intermediate dose melphalan because of an age of more than 65 years.
    - Patients may have received up to 6 cycles of prior induction therapy (e.g. idarubicine, dexamethasone) and up to 2 cycles of prior mobilisation chemotherapy (e.g. cyclophosphamide). A bortezomib or thalidomide containing induction therapy is allowed. Patients may also have received prior radiation therapy. The use of lenalidomide as monotherapy or as part of a combination treatment for induction therapy is not allowed.
    - Measurable levels of myeloma paraprotein in serum (>0.5 g/dL) or urine (>0.2 g/24hours) or measurable free light chains (FLC) in serum (>50 mg/l) with an abnormal FLC ratio must be documented at the time of first diagnosis.
    - ECOG performance status of £ 2 at study entry.
    - Laboratory and functional test results within these ranges: ANC ≥ 1,000/μL , Platelet count ≥ 100,000/μL, Total bilirubin £ 2.5 mg/dL, AST (SGOT) and ALT (SGPT) 3 x ULN, Patients with impaired renal function can be included
    - The patient must be able to adhere to the pregnancy precautions.
    Disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast.
    - Schriftliches Einverständnis
    - Alter 18-75 Jahre
    - Patienten mit Multiplen Myelom mit Hochdosischemotherapie und anschließender Transplantation von eigenen Blutstamm-zellen als Primärbehandlung innerhalb der letzten 90 – 120 Tage (ohne Progression). Eine zweite Hochdosistherapie im Anschluss an die erste ist erlaubt, wenn der Patient weniger als eine sehr gute partielle Remission erreicht hat oder aufgrund eines Alters von mehr als 65 Jahren eine intermediäre Melphalan-konditionierung gewählt wurde. Patienten dürfen bis Einschluss bis zu 6 Zyklen Induktions-Chemotherapie (z.B. mit Idarubicin, Dexamethason) und bis zu zwei Zyklen Mobilisations-Chemotherapie (z.B. mit Cyclophosphamid) erhalten haben. Patienten mit einer Induktions-Therapie die Bortezomib enthielt oder vorheriger Bestrahlung können eingeschlossen werden. Eine Vorbehandlung durch Thalidomid oder Lenalidomid führt zum Ausschluss des Patienten.
    - Ein messbarer Verlaufsparameter muss vorhanden sein. Ein Paraprotein im Serum >0.5 g/dl) oder im Urin (>0.2 g/24Std) oder eine freie Leichtkette (FLC) im Serum (>50 mg/l) mit einem pathologischen FLC-Quotienten muss zum Zeitpunkt der Erstdiagnose vorliegen
    - ECOG Allgemeinzustand < oder gleich 2
    - Labor-Ergebnisse müssen innerhalb folgender Grenzwerte liegen:
    - Gesamtbilirubin < oder gleich 2.5 mg/dl
    - AST (SGOT) and ALT (SGPT) < oder gleich 3 x oberer
    Normbereich
    - Patienten mit eingeschränkter Nierenfunktion können nach
    Prüfplan (Dosismodifikationen) eingeschlossen werden.
    - Patienten müssen sich an die Schwangerschaftsverhütungs-massnahmen innerhalb der Studien halten. Diese sehen vor, dass weibliche Patienten einen Schwangerschaftstest vor Studienteilnahme durchführen Männliche und weibliche Patienten müssen vor, während und nach Studienteilnahme unbedingt einer sicheren Verhütungsmethode zustimmen und dies schriftlich bestätigen. Patientinnen, die während der Studie schwanger werden, müssen dem besonderen Vorgehen zu Schwangerschaften in der LenaMain-Studie schriftlich zustimmen.
    - Patienten dürfen in den letzten 5 Jahren an keiner malignen Erkrankung gelitten haben, mit Ausnahme eines Basalzellkarzinoms oder eines squamösen Zellkarzinoms der Haut oder eines “carcinoma in situ” der Zervix oder der Brust.
    E.4Principal exclusion criteria
    - Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
    - Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
    - Any condition or laboratory abnormality which places the subject at an unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
    - Known hypersensitivity to thalidomide.
    - The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
    - Any prior use of thalidomide or lenalidomide.
    - Known positive for HIV or active infectious hepatitis, type A, B or C.
    - Alle medizinischen Zustände, laborchemischen Veränderungen oder psychiatrischen Zustände, die eine Unterzeichnung der Einverständniserklärung nicht möglich machen.
    - Schwangere oder Stillende Teilnehmerinnen
    - Alle laborchemischen Veränderungen, die ein nicht akzeptables Risiko für den Patienten bei einer Studienteilnahme bedeuten würden oder die Studienauswertung beeinflussen könnte.
    - Bekannte Überempfindlichkeit gegenüber Thalidomid oder Thalidomidabkömmlinge
    - Entwicklung eines Erythema nodosum während der Gabe von Thalidomid oder ähnlichen Medikamenten.
    - Vorherige Gabe von Thalidomid oder Lenalidomid
    - Aktive HIV oder Hepatitis, A, B oder C Infektion
    E.5 End points
    E.5.1Primary end point(s)
    - Compare the event-free survival of patients with multiple myeloma who receive two different dose levels (25 vs. 5 mg daily) of lenalidomide as maintenance therapy after first line high-dose therapy and autologous stem cell transplantation.
    Evaluation und Vergleich des ereignisfreien Überlebens zwischen Hochdosis (25 mg) und Niedrigdosisarm (5 mg) bei Patienten nach Hochdosistherapie und autologer Blutstammzelltransplantation
    E.5.1.1Timepoint(s) of evaluation of this end point
    disease progession
    Eintritt des Krankheitsprogress
    E.5.2Secondary end point(s)
    - Safety and tolerability number of SAE
    - remission rate
    - overall survival
    - Quality of life (QoL)
    - progression-free Survival 2 (PFS2)
    -Sicherheit, Verträglichkeit und Machbarkeit
    -Remissionsrate (RR)
    -Gesamtüberleben (OS)
    - Lebensqualität (QoL)
    - progressionsfreies Überleben 2 (PFS2)

    E.5.2.1Timepoint(s) of evaluation of this end point
    every visit until disease progression
    Routinevisiten bis zur Krankheitsprogression
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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
    Hoch- und Niedrigdosisarm
    Highdose and Lowdosearm
    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 concerned4
    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 Information not present in EudraCT
    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
    disease progression
    Krankheitsprogression
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months6
    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: 94
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state194
    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)
    In the follow-up phase all subjects will be followed for survival and post anti-myeloma treatment.
    Alle Patienten erhalten eine umfassende Nachsorge und eine spezielle Therapie.
    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 Decision2009-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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