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    Summary
    EudraCT Number:2008-007157-12
    Sponsor's Protocol Code Number:CNTO328MMY2001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-31
    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 ConcernedFrance - ANSM
    A.2EudraCT number2008-007157-12
    A.3Full title of the trial
    A Randomized, Open label, Phase 2 Study of CNTO 328 (Anti-IL 6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone Compared With VELCADE-Melphalan-Prednisone for the Treatment of Previously Untreated Multiple Myeloma
    A.4.1Sponsor's protocol code numberCNTO328MMY2001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCentocor BV
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 nameCNTO 328
    D.3.2Product code CNTO 328
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCNTO 328
    D.3.9.3Other descriptive nameChimeric Murine Human anti-IL6 monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeMonoclonal antibody
    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
    Previously untreated symptomatic multiple myeloma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1
    To assess the safety of CNTO 328 at a dose of 11 mg/kg every 3 weeks when administered in combination with VMP.

    Part 2
    To demonstrate improved efficacy, as assessed by complete response (CR) rate using the European Group for Blood and Marrow Transplantation (EBMT) criteria, of CNTO 328 in combination with VMP.
    E.2.2Secondary objectives of the trial
    Part 1
    To explore the efficacy, pharmacokinetics, and pharmacodynamics of CNTO 328 in combination with VMP.

    Part 2
    To assess additional measures of clinical benefit, safety, pharmacokinetics, and biomarkers of CNTO 328 in combination with VMP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years old
    2. Subjects must have signed informed consent indicating that they understand the purpose of and procedures required for the study, and are willing to participate in the study.
    3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of < or = 2
    4. Confirmed diagnosis of multiple myeloma (International Myeloma Working Group [IMWG] criteria) requiring treatment
    5. Subject is not a candidate for high dose chemotherapy with stem cell transplantation due to:
    a. Age ≥ 65 years, or
    b. In subjects < 65 years: presence of important comorbid condition(s) likely to have a negative impact on the tolerability of high dose chemotherapy with stem cell transplantation. Sponsor review of these comorbid conditions and approval is required before randomization.
    6. Measurable secretory disease, defined as either serum monoclonal paraprotein (M protein) ≥ 1 g/dL or urine monoclonal (light chain) protein > 200 mg/24 hours
    7. Have pretreatment clinical laboratory values meeting the protocol criteria within 14 days before treatment
    8. Female subjects must be postmenopausal (at least 12 months since last menses),
    surgically sterile, abstinent, or, if sexually active, be practicing an effective method
    of birth control (eg, prescription oral contraceptives, contraceptive injections,
    intrauterine device, double-barrier method, contraceptive patch, male partner
    sterilization) before study entry, for the duration of study participation, and for
    6 months after the last administration of study agent, and must have a negative
    serum or urine pregnancy test within 1 week before beginning treatment. Men
    must be sterilized or agree to use a double-barrier method of birth control and must
    agree to not donate sperm during the study and for 6 months after the last
    administration of study agent.
    9. Subjects must be able to adhere to study visit schedule and all protocol requirements.
    10. The anticipated life expectancy is such that the subject will be able to participate for the duration of the study
    E.4Principal exclusion criteria
    1. Diagnosis of primary amyloidosis, asymptomatic or smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (MGUS)
    2. Diagnosis of Waldenström’s disease, or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
    3. Prior or current systemic therapy or stem cell transplantation for multiple myeloma (including, corticosteroids, clarithromycin, mAbs, immunotherapy, investigative therapy, or immunosuppressive therapy) with the exception of emergency use of a short course (maximum 4 days) of corticosteroids before treatment
    4. Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events
    5. Radiation therapy within 14 days before treatment
    6. Plasmapheresis within 14 days before treatment
    7. Major surgery within 14 days before treatment
    8. Transplanted solid organ, with the exception of a corneal transplant (≥ 3 months
    before treatment)
    9. History of allergic reaction or hypersensitivity to boron or mannitol, or known allergies or clinically significant reactions to murine, chimeric, or human proteins
    10. Concurrent medical condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study
    11. Serious concurrent illness or history of uncontrolled heart disease such as unstable angina, congestive heart failure, myocardial infarction within preceding 12 months, or clinically significant rhythm or conduction abnormality
    12. Prior or concomitant malignancy except adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancer for which the subject has undergone potentially curative therapy and has no evidence of that disease for ≥ 5 years
    13. Vaccinated with live, attenuated vaccines within 4 weeks of the first administration of CNTO 328
    14. Known infection with HIV, known hepatitis C infection, or known to be hepatitis B surface antigen positive
    15. Use of any investigational agents within 30 days or 5 half lives (whichever is
    longer) of treatment
    16. Pregnant or lactating women
    E.5 End points
    E.5.1Primary end point(s)
    Safety for Part 1 and CR rate, based on the EBMT criteria for Part 2
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    PRO
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Is provided in the protocol
    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 years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 116
    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 Decision2010-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-11
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