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    Summary
    EudraCT Number:2011-001775-39
    Sponsor's Protocol Code Number:BDT-01-2011
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-14
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-001775-39
    A.3Full title of the trial
    PHASE II MULTICENTER CLINICAL TRIAL TO INVESTIGATE THE EFFICACY AND
    SAFETY OF BENDAMUSTINE, DEXAMETHASONE AND THALIDOMIDE IN
    RELAPSED OR REFRACTORY MULTIPLE MYELOMA PATIENTS AFTER TREATMENT
    WITH LENALIDOMIDE AND BORTEZOMIB OR WHICH ARE INELIGIBLE TO ONE OF
    THESE DRUGS.
    STUDIO MULTICENTRICO DI FASE II PER VALUTARE L'EFFICACIA E LA SICUREZZA DI BENDAMUSTINA, DESAMETASONE E TALIDOMIDE IN PAZIENTI CON MIELOMA MULTIPLO RICADUTI O REFRATTARI POST TRATTAMENTO CON LENALIDOMIDE E BORTEZOMIB O RESISTENTI A UNA O ENTRAMBI DI ESSI.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BENDAMUSTINE, DEXAMETHASONE AND THALIDOMIDE IN
    RELAPSED OR REFRACTORY MULTIPLE MYELOMA PATIENTS.
    BENDAMUSTINA, DESAMETASONE E TALIDOMIDE IN PAZIENTI
    CON MIELOMA MULTIPLO RICADUTI O REFRATTARI.
    A.4.1Sponsor's protocol code numberBDT-01-2011
    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 SponsorAZIENDA SANITARIA DELL'ALTO ADIGE - COMPRENSORIO SANITARIO DI BOLZANO
    B.1.3.4CountryItaly
    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 PHARMACEUTICALS SRL
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAZIENDA OSPEDALIERA DI BOLZANO
    B.5.2Functional name of contact pointDIVISIONE DI EMATOLOGIA E TMO
    B.5.3 Address:
    B.5.3.1Street AddressVIA LORENZ BOEHLER 5
    B.5.3.2Town/ cityBOLZANO
    B.5.3.3Post code39100
    B.5.3.4CountryItaly
    B.5.4Telephone number0471908807
    B.5.5Fax number0471908703
    B.5.6E-mailmichael.mian@asbz.it
    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 Ribomustin
    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.3.4Pharmaceutical form Powder and solvent 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 3543757
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    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
    Relapsed or refractory active MM (according to the International Myeloma Working Group guidelines) after treatments containing bortezomib and lenalidomide or ineligible (intolerance or toxicity) to one of these drugs with detectable myeloma
    protein in blood or urine.
    Mieloma multiplo attivo ricaduto o refrattario (in accordo con le linee guida del International Myeloma Working Group) dopo trattamenti che includevano bortezomib o lenalidomide o ineleggibili (intolleranza o tossicità) a uno di questi farmaci con proteina monoclonale nel sangue o nelle urine.
    E.1.1.1Medical condition in easily understood language
    Relapsed or refractory Multiple Myeloma.
    Mieloma multiplo in recidiva o non rispondente alle terapie.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10051381
    E.1.2Term Myeloma recurrence
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of BDT in relapsed or refractory multiple myeloma as measured by the rate of responses (time frame 18 months).
    Valutare l’efficacia di Bendamustina, Desametasone e Talidomide (BDT) in pazienti con MM ricaduti o refrattari post trattamento con lenalidomide e bortezomib o resistenti ad una o entrambi di essi, misurata come percentuale di risposte.
    E.2.2Secondary objectives of the trial
    To assess:
    - tolerability and toxicity
    - Time to treatment failure and overall survival
    - Disease free survival
    Valutare:
    - tollerabilità e tossicità
    - sopravvivenzaq globale e tempo al fallimento della terapia
    -sopravvivenza libera da malattia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Relapsed or refractory active MM after treatments containing bortezomib and lenalidomide or
    ineligible to one of these drugs.
    • Age 18 years.
    • All previous multiple myeloma treatments, including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this
    study, except corticosteroids therapy.
    • ECOG performance status <2 at study entry, unless it is due to MM.
    • Mieloma multiplo attivo ricaduto o refrattario dopo trattamenti che includevano bortezomib o lenalidomide o ineleggibili (intolleranza o tossicità) a uno di questi farmaci
    • Età &gt; 18 anni.
    • Tutti trattamenti per mieloma multiplo, incluso radioterapia, terapia citostatica o
    chirurgia, eccetto steroidi devono essere stati terminati almeno 4 mesi prima.
    • ECOG performance status &lt; 2, ad eccezione se causato dal MM.
    E.4Principal exclusion criteria
    • Patients with contraindications for treatment with bendamustine, dexamethasone and
    thalidomide.
    • Uncontrolled or severe cardiovascular disease.
    • Known hypersensitivity to thalidomide or purine analogues
    • Concurrent use of other anti-cancer agents or treatments other stated in this treatment plan.
    • Peripheral neuropathy grade ≥2 according to WHO
    • Known positive for HIV or infectious hepatitis, type A, B or C.
    • Pregnant or breast feeding females.
    • Pazienti con controindicazioni al trattamento con bendamustina, desametasone e/o thalidomide.
    • Malattia cardiovascolare grave o incontrollata.
    • Uso di qualsiasi altro farmaco sperimentale o terapia entro 28 giorni dall’ingresso dello studio.
    • Ipersensibilità a talidomide o analoghi purinici.
    • Uso concomitanti di farmaci anti-neoplastici oltre a quelli previsti in questo protocollo.
    • Neuropatia periferica grado ≥2 secondo WHO
    • Infezione o positività sierologica per HIV or epatite tipo A, B or C.
    • Donne gravide o che allattano.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy as measured by the rate of responses
    Efficacia in termini di percentuale di risposte
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 18 months.
    18 mesi
    E.5.2Secondary end point(s)
    Time to treatment failure, overall survival and disease free survival at 18 months.
    Tempo al fallimento del trattamento, sopravvivenza globale e sopravvivenza libera da malattia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 months.
    18 mesi.
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned13
    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 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
    LVLS
    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.1.1Number of subjects for this age range: 0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state30
    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)
    Subjects will bel treated up to 6 months and then followed for a 18 months period.
    I soggetti verranno trattati per un massimo di 6 mesi e poi seguiti per il follow up per un periodo di 18 mesi.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Laboratorio di Ricerca Clinica C/O Centro Oncologico Modenese
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-08
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