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    Summary
    EudraCT Number:2006-001897-26
    Sponsor's Protocol Code Number:C0328T05
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-07-05
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2006-001897-26
    A.3Full title of the trial
    A Phase 2 Multicenter Study of CNTO 328 (Anti Interleukin 6 Monoclonal Antibody) in Subjects with Relapsed or Refractory Multiple Myeloma
    A.3.2Name or abbreviated title of the trial where available
    C0328T05 in relapsed/refractory MM patients
    A.4.1Sponsor's protocol code numberC0328T05
    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 B.V.
    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 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.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeCNTO 328
    D.3.9.3Other descriptive namechimeric murine human anti–IL-6 monoclonal antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    relapsed or refractory multiple myeloma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are to assess the safety and efficacy of CNTO 328 administered as an IV infusion in subjects with relapsed or refractory multiple myeloma
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the pharmacokinetics, pharmacodynamics, and immune response of CNTO 328 administered as an IV infusion in subjects with relapsed or refractory multiple myeloma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for the study, subjects must meet all of the following criteria:

    1. Male or female age ≥ 18 years

    2. Signed informed consent obtained prior to any study-specific screening procedures

    3. Genetic testing Subjects must have signed the informed consent for genetic testing indicating whether they do or do not wish to participate in the genetic part of the study. Participation in the genetic testing component is not mandatory for participation in the study

    4. Confirmed diagnosis of multiple myeloma

    5. Relapsed or refractory disease defined as:
    a. Failed at least 2 prior lines of therapy
    b. Documented relapse after completion of last treatment or no response to last prior therapy. Progression on prior therapy is defined according to EBMT criteria.
    c. Other acceptable prior lines of therapy include: High-dose corticosteroids, autologous stem cell transplant (high-dose corticosteroids followed by autologous stem cell transplant are considered 1 line of therapy), lenalinomide/thalidomide (alone or in combination with other agents), anthracycline and/or alkalylating agent (melphalan) (alone or in combination with other agents), and bortezomib (alone or in combination with other agents)

    6. Prior treatment regimen must have included bortezomib (alone or in combination with other agents)

    7. Measurable secretory disease defined as either serum monoclonal paraprotein (M protein) ≥ 1 g/dL or urine monoclonal (light chain) protein (> 200 mg/24 hours)

    8. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2

    9. Subjects experiencing toxicities resulting from previous therapy must have fully recovered or stabilized to ≤ Grade 1

    10. Subjects of childbearing potential must use adequate birth control measures. Female subjects of childbearing potential must have a negative serum pregnancy test at screening

    11. Adequate bone marrow, liver, and renal function prior to treatment:
    a. Hemoglobin ≥ 7.5 g/dL (4.7 mmol/L; 75 g/L) with or without transfusion dependency
    b. Platelets ≥ 50,000/mm3 without transfusion dependency.
    c. Absolute neutrophil count (ANC) ≥ 1000 mm3 without hematopoietic cytokine support
    d. AST, ALT, and alkaline phosphatase ≤ 3 x ULN
    e. Bilirubin ≤ 2 x ULN
    f. Calculated creatinine clearance ≥ 20 mL/min
    g. Corrected serum calcium ≤ 11.5 mg/dL (2.8 mmol/L)

    12. Able to adhere to study visit schedule and all protocol requirements
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria may not be enrolled in the study:

    1. Treatment with systemic cancer therapy (including clarithromycin) or radiotherapy within 30 days before the first dose of study agent

    2. Treatment with nitrosoureas within 42 days before the first dose of study agent

    3. Major surgery within 30 days before the first dose of study agent or planning to have surgery (except for minor surgical procedures) during the study

    4. Received any investigational drug/agent within 30 days or 5 half-lives, whichever is longer

    5. Received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant

    6. Has clinically significant residual toxicities associated with prior autologous bone marrow or peripheral blood stem cell transplant

    7. Administered platelet transfusion or neutrophil growth factor within 2 weeks prior to the collection of screening hematology laboratory sample

    8. Transplanted solid organ with the exception of a corneal transplant (≥ 3 months prior to screening)

    9. Received any mAb within 60 days of first dose of study agent

    10. Serious concurrent illness (medical or psychiatric), uncontrolled infection, or significant cardiac disease characterized by significant ischemic coronary disease or congestive heart failure not under medical control, or any uncontrolled medical condition (eg, uncontrolled diabetes), including the presence of clinical laboratory abnormalities, that places the subject at unacceptable risk by participating in the study or confounds the ability to interpret data from the study

    11. Prior or concomitant malignancy (other than multiple myeloma) 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 been disease-free for ≥ 3 years

    12. Any other concomitant disease-related treatment such as, immunotherapy, biotherapy, radiotherapy, chemotherapy, investigative therapy, or immunosuppressive therapy/corticoid steroids (other than study specific treatment with dexamethasone)

    13. Vaccinated with live or attenuated vaccines within 4 weeks of the first administration of CNTO 328

    14. Known to be seropositive for HIV, or active hepatitis A, B or C infection

    15. Pregnant or lactating women
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is overall response rate for CNTO 328 if Treatment Plan B is not used. Otherwise, the primary endpoint is the overall response rate of CNTO 328 plus dexamethasone (Treatment Plan B).
    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 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 Yes
    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.8.3 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 concerned2
    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 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 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
    Provided in the protocol
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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 10
    F.4.2.2In the whole clinical trial 40
    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)
    Not different from the expected normal treatment
    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 Decision2006-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-03
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