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    Summary
    EudraCT Number:2014-000130-37
    Sponsor's Protocol Code Number:MM-SDX-105-01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-02-06
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-000130-37
    A.3Full title of the trial
    Prospective, phase II study to evaluate the efficacy and the safety of a combination of bendamustine-melphalan as preparative regimen to autologous transplantation of hematopoietic cells for multiple myeloma who have relapsed after previous high-dose therapy
    STUDIO DI FASE II, PROSPETTICO PER VALUTARE L'EFFICACIA E LA SICUREZZA DELL'ASSOCIAZIONE DI BENDAMUSTINA-MELFALAN COME REGIME PREPARATORIO AL TRAPIANTO AUTOLOGO DI CELLULE EMATOPOIETICHE IN PAZIENTI AFFETTI DA MIELOMA MULTIPLO CHE SONO RECIDIVATI DOPO PRECEDENTI TERAPIE AD ALTE DOSI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the efficacy and the safety of a combination of bendamustine-melphalan as preparative regimen to autologous transplantation of hematopoietic cells for multiple myeloma who did not responded after previous high-dose therapy
    STUDIO CLINICO PER VALUTARE L'EFFICACIA E LA SICUREZZA DELL'ASSOCIAZIONE DI BENDAMUSTINA-MELFALAN COME REGIME PREPARATORIO AL TRAPIANTO AUTOLOGO DI CELLULE EMATOPOIETICHE IN PAZIENTI AFFETTI DA MIELOMA MULTIPLO CHE NON HANNO RISPOSTO A PRECEDENTI TERAPIE AD ALTE DOSI.
    A.4.1Sponsor's protocol code numberMM-SDX-105-01
    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 SponsorFONDAZIONE NEOPLASIE SANGUE ONLUS (FO.NE.SA. Onlus)
    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
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFONDAZIONE NEOPLASIE SANGUE ONLUS (FO.NE.SA. Onlus)
    B.5.2Functional name of contact pointUfficio Sperimentazioni Cliniche
    B.5.3 Address:
    B.5.3.1Street AddressVia Genova 3
    B.5.3.2Town/ cityTorino
    B.5.3.3Post code10126
    B.5.3.4CountryItaly
    B.5.4Telephone number390116336107
    B.5.5Fax number390116963737
    B.5.6E-mailgismm@yahoo.com
    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, Postfach 50 01 66, D-80971 München
    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 nameLevact ® i.v.
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Powder and solution for solution 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 Yes
    D.3.11.13.1Other medicinal product typeAntitumor alkylating agent
    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
    Mieloma multiplo
    E.1.1.1Medical condition in easily understood language
    Patients with multiple myeloma
    Pazienti con mieloma multiplo
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    EVALUATE THE EFFICACY AND THE SAFETY OF A COMBINATION OF BENDAMUSTINE-MELPHALAN AS PREPARATIVE REGIMEN TO AUTOLOGOUS TRANSPLANTATION OF HEMATOPOIETIC CELLS FOR MULTIPLE MYELOMA WHO HAVE RELAPSED AFTER PREVIOUS HIGH-DOSE THERAPY
    VALUTARE L'EFFICACIA E LA SICUREZZA DELL'ASSOCIAZIONE DI BENDAMUSTINA-MELFALAN COME REGIME PREPARATORIO AL TRAPIANTO AUTOLOGO DI CELLULE EMATOPOIETICHE IN PAZIENTI AFFETTI DA MIELOMA MULTIPLO CHE SONO RECIDIVATI DOPO PRECEDENTI TERAPIE AD ALTE DOSI.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥ 18 ≤ 70 years.
    • Multiple myeloma patients who have relapsed after first-line therapy including ASCT (single or tandem) with an interval between the last ASCT and clinical relapse of at least 12 months.
    • At least stable disease after ≥ 4-6 cycles of salvage treatment (see specific chapter in the protocol)
    • Performance of patient screening between 30 and 90 days after the end of salvage treatment
    • Measurable myeloma defined by M-protein > 1000 mg/dL if IgG or 500 mg/dL if IgA or Bence Jones protein > 200 mg/24 h or free light chain > 100 mg/L or measurable extramedullary plasmacytoma > 2 cm at the time of relapse and before the beginning of salvage treatment.
    • Collection of at least 3 x 106/Kg autologous hematopoietic stem cell (harvested at any time)
    • HCT-CI ≤ 5
    • Adequate cardiac function with left ventricular ejection fraction ≥ 50%.
    • Adequate renal function with Clearance creatinine ≥ 50 ml/min
    • Adequate hepatic function with serum bilirubin <1,5 mg/L and AST and ALT values < 100 UI/L.
    • Adequate pulmonary function with DLCO > 30% and/or no need of supplementary oxygen.
    • Able to adhere to the study visit schedule and other protocol requirement.
    • Disease free of prior malignancies for at least 2 years.
    • Women of child bearing potential and male patients whose partner is a woman of child bearing potential must be prepared to use effective methods of contraception both before and during protocol treatment, or commit to absolute and continuous abstinence. Men must not father a child for up to 6 months following cessation of treatment and must use condoms.
    • Written informed consent.
    • Età ≥ 18 e ≤ 70 anni.
    • Pazienti affetti da mieloma multiplo che sono recidivati dopo la terapia di prima linea incluso ASCT (singolo o doppio) con un intervallo di almeno 12 mesi tra l'ultimo ASCT e la recidiva clinica.
    • Almeno malattia stabile (SD) dopo ≥ 4-6 cicli di trattamento di salvataggio (vedere il capitolo specifico nel protocollo).
    • Screening tra 30 e 90 giorni dalla fine del trattamento di salvataggio
    • Malattia quantificabile definita da valori di proteina monoclonale > 1000 mg/dL se la malattia interessa le IgG o 500 mg/dL se la malattia interessa le IgA o proteina di Bence Jones > 200 mg/24 h o catene leggere libere > 100 mg/L o plasmocitoma extramidollare misurabile > 2 cm al momento della recidiva e prima dell'inizio del trattamento di salvataggio.
    • Raccolta di almeno 3 x 106/Kg di cellule staminali ematopoietiche autologhe (raccolte in qualsiasi momento)
    • HCT-CI ≤ 5
    • Funzione cardiaca adeguata con frazione di eiezione ventricolare sinistra ≥ 50%.
    • Funzione renale adeguata con clearance della creatinina ≥ 50 ml/min
    • Funzione epatica adeguata con bilirubina sierica <1,5 mg/L e transaminasi < 100 UI/L.
    • Funzione polmonare adeguata con DLCO > 30% e/o nessuna necessità di ossigeno supplementare.
    • Possibilità aderire alle visite programmate previste dello studio e ad altre richieste previste dallo studio.
    • Assenza di precedenti neoplasie per almeno 2 anni.
    • Donne potenzialmente fertili e pazienti di sesso maschile, la cui partner risulti potenzialmente fertile, che utilizzino efficaci metodi contraccettivi sia prima che durante il trattamento previsto dal protocollo o che accettino di astenersi dai rapporti sessuali per tutta la durata del trattamento. Gli uomini non dovranno procreare fino a 6 mesi dopo la sospensione del trattamento e dovranno usare il preservativo.
    • Consenso informato scritto.
    E.4Principal exclusion criteria
    • Early relapse defined by an interval between the last ASCT and clinical relapse requiring salvage treatment < 12 months.
    • Progression after ≥ 3 cycles of salvage treatment.
    • Plasma cell leukaemia.
    • SNC myeloma localization.
    • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
    • Any active infection (e.g. failure to resolve previous infections or new infections)
    • Pregnant or breast feeding females.
    • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
    • Positive serologic markers for human immunodeficiency virus (HIV).
    • Acute hepatitis B virus (HBV) with positive HBsAg and/or HBV-DNA. Patients having negative HBV-DNA, but with HBcAb positive serology, will not be excluded from the study and be given Lamivudine (100 mg /die) as prophylaxis starting one week before chemotherapy. HbsAg and AST/ALT and HBVDNA will be monitored every three weeks. Lamivudine therapy should be continued for one year after the end of therapy.
    • Acute hepatitis C virus (HCV) infection with positive HCV-RNA.
    • Major surgery less than 30 days before start of treatment.
    • Patients not agreeing to take adequate contraceptive measures during the study.
    • Any active, uncontrolled infection.
    • Recidiva precoce definita come intervallo tra l'ultimo ASCT e la recidiva clinica che richiede un trattamento di salvataggio <12 mesi.
    • Progressione dopo ≥ 3 cicli di trattamento di salvataggio.
    • Leucemia plasmacellulare.
    • Mieloma localizzato a livello del SNC.
    • Qualsiasi condizione medica seria, anomalie di laboratorio, o problemi psichiatrici che impedirebbero al soggetto di firmare il modulo di consenso informato.
    • Qualsiasi infezione attiva (es. Infezione precedente non risolta oppure nuove infezioni)
    • Donne in gravidanza o in allattamento.
    • Qualsiasi condizione, inclusa la presenza di anomalie di laboratorio, che possano porre il soggetto ad un rischio inaccettabile se lui/lei dovessero partecipare allo studio o che possano confondere la capacità di interpretare i dati dallo studio.
    • Markers sierologici positivi per infezioni da virus dell'immunodeficienza acquisita umana (HIV).
    • Infezione acuta da epatite B (HBV) con HBsAg e/o HBV-DNA positivi. Pazienti con HBV-DNA negativo, ma con HBcAb sierologico positivo, non saranno esclusi dallo studio e dovranno assumere Lamivudina (100 mg /die) come profilassi a partire da una settimana prima dell'inizio della chemioterapia. I parametri HbsAg, AST/ALT e HBV-DNA saranno monitorati ogni 3 settimane. La terapia con Lamivudina dovrebbe essere assunta per un anno dopo il termine della terapia.
    • Infezione acuta da epatite C (HCV) con HCV-RNA positivo.
    • Interventi chirurgici importanti entro 30 giorni prima dell'inizio del trattamento.
    • Pazienti che non accettano di assumere adeguati metodi contraccettivi durante la durata dello studio.
    • Qualsiasi infezione attiva non controllata.
    E.5 End points
    E.5.1Primary end point(s)
    • Rate of new VGPR+CR on day + 100 after transplant in comparison with pre-transplant evaluation
    • Toxicity rate evaluated as proportion of patients developing at least one event of grade 3 and 4 extrahematological toxicity
    • Tasso di VGPR + CR al giorno +100 dopo trapianto rispetto alla valutazione pre-trapianto
    • Tasso di tossicità valutato come proporzione di pazienti che hanno sviluppato almeno un evento di tossicità extra ematologiche di grado 3 e 4
    E.5.1.1Timepoint(s) of evaluation of this end point
    +100
    +100
    E.5.2Secondary end point(s)
    • Engraftment
    • Transplant-related.-mortality (TRM)
    • Rate of grade 3 and 4 mucositis
    • Rate of cumulative VGPR + CR on day +100 (after salvage treatment and after transplant)
    • Progression-free survival
    • Overall survival
    • Engraftment
    • Mortalità correlata al trapianto (TRM)
    • Tasso di mucositi di grado 3 e 4
    • Tasso di VGPR+CR cumulativa al giorno +100 (dopo il trattamento di salvataggio e il trapianto)
    • Progressione libera da malattia
    • Sopravvivenza globale
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 years
    3 anni
    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 Yes
    E.8.1.7.1Other trial design description
    Studio prospettico
    Prospective study
    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 concerned18
    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 years
    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: 26
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state73
    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
    Nessuno
    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 Decision2014-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-07
    P. End of Trial
    P.End of Trial StatusOngoing
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