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    Summary
    EudraCT Number:2013-005485-19
    Sponsor's Protocol Code Number:BPV
    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:2014-07-18
    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 number2013-005485-19
    A.3Full title of the trial
    Bendamustine, Prednisone and Velcade® for first-line treatment of patients with symptomatic multiple myeloma not eligible for high-dose chemotherapy followed by autologous stem cell transplantation (BPV).
    Bendamustine, Prednisone und Velcade® als Erstlinienbehandlung von Patienten mit symptomatischem Multiplen Myelom, die nicht für eine Hochdosis Chemotherapie und anschließender Stammzelltransplantation geeignet sind (BPV)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Combination of Bendamustine, Bortezomib and Velcade as preferred treatment of patients with newly diagnosed multiple myeloma not eligible for high dose chemotherapy followed by stem cell transplantation
    Kombination von Bendamustine, Prednisone und Velcade® als bevorzugte Behandlung von Patienten mit symptomatischem Multiplen Myelom, die nicht für eine Hochdosis Chemotherapie und anschließender Stammzelltransplantation geeignet sind
    A.3.2Name or abbreviated title of the trial where available
    BPV
    A.4.1Sponsor's protocol code numberBPV
    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 SponsorRuprecht-Karls-University Heidelberg, Med Faculty represented by University Clinic HD and its Comm. Director
    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 supportMundipharma GmbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportJanssen-Cilag GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCoordination Centre for Clinical Trials (KKS)
    B.5.2Functional name of contact pointBaerbel Schurich
    B.5.3 Address:
    B.5.3.1Street AddressMarsilius-Arkaden-Turm West, Im Neuenheimer Feld 130.3
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69120
    B.5.3.4CountryGermany
    B.5.4Telephone number+49622156 34512
    B.5.5Fax number+49622156 33508
    B.5.6E-mailbaerbel.schurich@med.uni-heidelberg.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 Levact
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma GmbH
    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.3.1Product nameBendamustine
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBENDAMUSTINE HYDROCHLORIDE
    D.3.9.1CAS number 3543-75-7
    D.3.9.4EV Substance CodeSUB00696MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 100
    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 Yes
    D.3.11.13.1Other medicinal product typeCytostatic drug
    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 Velcade
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG INTERNATIONAL NV
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBortezomib
    D.3.4Pharmaceutical form Powder for concentrate for solution for injection/infusion
    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 INNBORTEZOMIB
    D.3.9.1CAS number 179324-69-7
    D.3.9.4EV Substance CodeSUB20020
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    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 Yes
    D.3.11.13.1Other medicinal product typeCytostatic drug
    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.2.5The 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
    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 INNPrednisone
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 50
    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 Yes
    D.3.11.13.1Other medicinal product typeGlucocorticoid
    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 (symptomatic, newly diagnosed) not eligible for high dose chemotherapy and subsequent stem cell transplantaion
    symptomatisches Multiples Myelom, Neudiagnose, nicht geeignet für Hochdosischemotherapie und anschließender Stammzelltransplantation
    E.1.1.1Medical condition in easily understood language
    newly diagnosed multiple Myeloma not eligible for high dose chemotherapy and stem cell transplantation
    neu diagnostiziertes Multiples Myelom, Patient für Hochdosistherapie und anschließende Stammzelltransplantation nicht geeignet.
    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 19.1
    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
    The main purpose of the study is to demonstrate the efficacy of BPV to efficiently decrease myeloma tumour burden.
    Nachweis der therapeutischen Wirksamkeit von PBV bezüglich erfolgreicher Verringerung der Tumorlast
    E.2.2Secondary objectives of the trial
    - Number and percentage of patients achieving a complete response (CR)
    -Progression-free survival (PFS)
    -Overall survival (OS)
    -Time-to-progression (TTP)
    -Disease-free survival (DFS)
    -Duration of response (DOR)
    - Renal response according Criteria for the Definition of Renal Response to Antimyeloma Therapy (IMWG), (CRrenal, PRrenal, MRrenal),
    -Toxicity (with respect to adverse events of CTCAE grade ≧3 and SAEs)
    -Zahl und % Patienten, die ein komplettes Ansprechen erreichen (CR)
    -Progressionsfreies Überleben (PFS)
    -Gesamtüberleben (OS)
    -Zeit bis zum Progress (TTP)
    -Krankheitsfreies Überleben (DFS)
    -Dauer des Ansprechens (DOR)
    -Ansprechen bezüglich der Niereninsuffizienz entsprechend den IMWG Kritierien (CRrenal, PRrenal, MRrenal)
    -Toxizität (unerwünschte Ereignisse ab CTC Grad 3 und schwerwiegende unerwünschte Ereignisse)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Newly diagnosed multiple myeloma requiring systemic treatment (according to CRAB criteria as specified in the appendix) with following characteristics: Subject is not a candidate for high-dose chemotherapy and stem cell transplantation due to age, presence of comorbidities likely to have a negative impact on tolerability of HDT-SCT, or subject preference
    2. Measurable disease, defined as any quantifiable monoclonal protein value, defined by at
    least one of the following three measurements (International Working Group , 2003 and Durie et al, 2006) (see appendix II)
    a. Serum M-protein ≥ 10g/l
    b. Urine light-chain (M-protein) of ≥ 200 mg/24 hours
    c. Serum FLC assay: involved FLC level ≥ 10 mg/dl provided sFLC ratio is abnormal
    3. Age ≥18 years
    4. WHO performance status 0-3 (WHO=3 is allowed only when caused by MM and not by co-morbid conditions) 5. For women of childbearing potential: negative pregnancy test at inclusion
    6. All men and women of childbearing potential must be willing and capable to use highly effective contraception during the complete therapy. [CPMP/ICH/286/95 mod: Highly effective
    methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e.,less than 1% per year) when used consistently and correctly. Examples of Highly effective and additional
    methods:- Intrauterine device (IUD), Hormonal (birth control pills, injections, implants), Tubal ligation,Partner’s vasectomy. Additional effective methods: Male condom, Diaphragm, Cervical Cap]
    7. All patients must agree to abstain from donating blood while on study
    8. Ability to understand character and individual consequences of the clinical trial
    9. Written informed consent (must be available before enrolment in the trial)
    1. Neu diagnostiziertes behandlungsbedürftiges Multiples Myelom (CRAB Kriterien, Appendix I) wenn folgende Kriterien zutreffen: Der Patient ist altersbedingt oder aufgrund von Begleiterkrankungen nicht für eine Hochdosistherapie mit anschließender Stammzelltransplantation (HDT-SCT) geeignet, oder der Patient wünscht keine HDT-SCT)
    2. Messbare Erkrankung durch quantifizierbares monoklonales Protein, definiert durch mindestens einen der folgenden Befunde:
    a) Serum M-protein ≥ 10g/l
    b) Urin Leichtkette (M-protein) of ≥ 200 mg/24 Stunden
    c) Serum FLC Assay: betroffener FLC Wert ≥ 10 mg/dl vorausgesetzt der sFLC ratio ist abnormal.
    3. Alter≥18 Jahre
    4. WHO Performance Status 0-3 (WHO=3 ist nur erlaubt wenn -bedingt durch Multiples Myeloma und nicht durch Begleiterkrankung verursacht)
    5. Frauen in gebärfähigem Alter müssen vor Studienbeginn einen negativen Schwanger-schaftstest vorweisen.
    6. Alle Patienten müssen willens und fähig sein eine adäquate Schwangerschaftsverhütung während der gesamten Studienlaufzeit zu gewährleisten.
    7. Alle Patienten müssen zustimmen während der Studienlaufzeit kein Blut zu spenden.
    8. Der Patient muss fähig sein das Wesen und die individuellen Konsequenzen der Studie zu verstehen.
    9. Eine unterschriebene Einwilligungserklärung muss vor Studienbeginn vorliegen.
    E.4Principal exclusion criteria
    Subjects presenting any of the following criteria will not be included in the trial:
    1. Patient has known hypersensitivity to bortezomib, bendamustine, prednisone or to any of the constituent compounds (incl. boron and mannitol).
    2. Systemic AL amyloidosis (except for patients with AL amyloidosis of the skin or the bone marrow)
    3. Previous chemotherapy or radiotherapy during the past 5 years except patient’s local radiotherapy in case of local myeloma progression. (Note: patients may have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy within 3 weeks prior to study entry.)
    4. Plasma cell leukaemia which requires the presence of 20% of plasma cell in peripheral blood leukocytes and at least 2/nl.
    5. Severe cardiac dysfunction (NYHA classification III-IV)
    6. Significant hepatic dysfunction (serum bilirubin ≥ 2 mg/dl or ASAT and/or ALAT ≥ 2.5 times normal level), unless related to myeloma
    7. Patients known to be HIV-positive
    8. Patients with active, uncontrolled infections
    9. Patients with peripheral neuropathy or neuropathic pain, CTC grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0)
    10. Second malignancy within the past 5 years except:
    a. Adequately treated basal cell or squamous cell skin cancer,
    b. Carcinoma in situ of the cervix, or
    c. Prostate cancer < Gleason score 6 with undetectable prostate-specific antigen (PSA) over 12 months, or
    d. Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins), or
    e. Similar condition with an expectation of > 95 % 5-year disease free survival
    11. Patients with acute diffuse infiltrative pulmonary and pericardial disease
    12. Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia
    13. Platelet count < 50 x 109/l (transfusion support within 14 days before the test is not allowed), unless related to myeloma
    14. Hemoglobin < 7.5g/dl, unless related to myeloma
    15. Absolute neutrophil count (ANC) < 0.75 x 109/l (the use of colony stimulating factors within 14 days before the test is not allowed), unless related to myeloma
    16. Pregnancy and lactation
    17. Participation in other clinical trials within one month prior to enrolment except patients for supportive care studies and vaccination studies. (Note: This does not include long-term follow-up periods without active drug treatment of previous studies during the last 6 months).
    1. bekannte Überempfindlichkeit gegen Bortezomib, Bendamustin, Prednison oder einen der Inhaltsstoffe (incl. Bor und Mannitol).
    2. Systemische AL Amyloidose (mit Ausnahme von Patienten mit AL Amyloidose der Haut oder des Knochenmarks)
    3. Chemotherapie oder Radiotherapie während der letzten 5 Jahre mit Ausnahme lokaler Radiotherapie im Fall lokaler Myelom Progression. (Cave: Patienten können eine kumulative Dosis bis zu 160 mg Dexamethason oder Äquivalent als Notfalltherapie innerhalb drei Wochen vor Studienbeginn erhalten)
    4. Plasmazell-Leukämie mit einem Plasmazellgehalt von 20% in den peripheren Blut Leukozyten und mindestens 2 Plasmazellen/nl.
    5. Schwere kardiale Störung (NYHA Klassifikation III-IV)
    6. Signifikante hepatische Störung (Serum Bilirubin ≥ 2 mg/dl oder ASAT und/oder ALAT ≥ 2.5 mal Normwert), außer myelombedingt.
    7. Patienten mit bekannter HIV-Positivität
    8. Patienten mit aktiver unkontrollierter Infektion
    9. Patienten mit peripherer Neuropathie oder neuropatischem Schmerz von CTC Grad 2 oder höher (definiert in den NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0)
    10. Zweit-Malignom während der letzten 5 Jahre mit Ausnahme von:
    a. Adäquat behandeltes Basalzell- oder Plattenepithel Karzinom der Haut, oder
    b. Carcinoma in situ der Zervix, oder
    c. Prostata-Karzinom < Gleason score 6 mit nicht nachweisbarem PSA-Wert über einen Zeitraum von 12 Monaten, oder
    d. Ductales Brust Karzinom in situ nach kompletter chirurgischer Entfernung und R0-Resektion, oder
    e. Eine vergleichbare maligne Erkrankung wie a.- d. bei der zu 95% eine mind. 5 jährige Krankheitsfreiheit angenommen werden kann.
    11. Patienten mit akuten diffusen Infiltraten in Lunge und Perikard
    12. Autoimmunbedingte hämolytische Anämie mit positivem Coombstest oder Thrombozytopenie
    13. Thrombozytenzahl < 50 x 109/l (keine Transfusion innerhalb 14 Tage vor dem Test erlaubt), Ausnahme myelombedingt
    14. Hämoglobin < 7.5g/dl, Ausnahme myelombedingt
    15. Absolute Neutrophilen Zahl (ANC) < 0.75 x 109/l (der Einsatz von “colony stimulating factors” innerhalb von 14 Tagen vor der Untersuchung ist nicht erlaubt), Ausnahme myelombedingt
    16. Schwangerschaft und Stillen
    17. Teilnahme an anderen klinischen Studien innerhalb eines Monats vor Einschluss, mit Ausnahme von Begleittherapie-Studien und Impfstudien (gilt nicht für Langzeit-Follow Up Perioden ohne Behandlung mit aktiven Substanzen während der letzten 6 Monate)
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Rate (ORR) of BPV, ORR is defined as PR or better.
    Gesamtansprechrate (ORR) nach BPV (definiert als partielle Remission PR oder besser)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Response evaluation after 3, 6 and 9 cycles BPV treatment, after premature treatment termination and during Follow-up everry 3 months until first progression
    nach 3,6,9. Monaten, nach vorzeitigem Behandlungsende und im Follow-up alle 3 Monate (bis zur Progression) Ermittlung des Ansprechens
    E.5.2Secondary end point(s)
    -Number and percentage of patients achieving a complete response (CR)
    -Progression-free survival (PFS)
    -Overall survival (OS)
    -Time-to-progression (TTP)
    -Disease-free survival (DFS)
    -Duration of response (DOR)
    - Renal response according Criteria for the Definition of Renal Response to Antimyeloma Therapy (IMWG), (CRrenal, PRrenal, MRrenal),
    -Toxicity (with respect to adverse events of CTCAE grade ≧3 and SAEs)
    - Zahl (und %) der Patienten, die ein Komplettes Ansprechen (CR) erreichen
    -Progressionsfreies Überleben (PFS)
    -Gesamtüberleben (OS)
    -Zeit bis zum Progress (TTP)
    -Erkrankungsfreies Überleben (DFS)
    -Dauer des Ansprechens DOR
    - Verbesserung der Nierenfunktion gemäß IMWG (komplette Remission ® renal, partielle remission (PR) renal, minimale remission (MR) renal-
    -Toxizität (bzgl. unerwünschter Ereignisse von CTCAE grade ≧3 und SAEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    any time
    jederzeit
    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 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 concerned19
    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
    End of trial is defined defined as the last Visit of the last subject undergoing the trial
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 41
    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 state46
    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)
    Supportive care as required per local guidelines.
    In patients with relapsed myeloma the treatment options depend on the compounds used in prior therapy, the duration of response, performance status, type of relapse, and previous toxicity. The decision about relapse treatment for a patient should be made by the investigator considering these issues. It is recommended that relapse treatment will be performed within a clinical trial.
    Weitere Betreuung entsprechend den lokalen Richtlinien.
    Bei einem Rückfall der Erkrankung richtet sich die Behandlung nach den früheren Therapien, der Dauer des Ansprechens, des körperlichen Zustandes, der Art des Rückfalls und früheren Toxizitäten. Die Entscheidung über die Therapie bei Rückfall sollte der Behandler treffen, indem er diese Komponenten berücksichtigt. Es wird empfohlen die Behandlung eines Krankheitsrückfalles im Rahmen einer klinischen Studie durchzuführen
    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 Decision2014-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-01
    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
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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