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    Summary
    EudraCT Number:2006-000026-31
    Sponsor's Protocol Code Number:ML18704
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-01-18
    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 ConcernedAustria - BASG
    A.2EudraCT number2006-000026-31
    A.3Full title of the trial
    Bevacizumab as treatment for patients with relapsed/refractory multiple myeloma
    A.3.2Name or abbreviated title of the trial where available
    Avastin in MM
    A.4.1Sponsor's protocol code numberML18704
    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 SponsorRoche Austria GmbH
    B.1.3.4CountryAustria
    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 Information not present in EudraCT
    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 nameBevacizumab
    D.3.2Product code RO4876646
    D.3.4Pharmaceutical form Concentrate 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.3.8INN - Proposed INNBevacizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25mg/ml
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 typerecombinant humanised monoclonal 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
    Multiple myeloma, relapsed/refractory after at least 2 lines of prior therapy
    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
    To evaluate the activity of Bevacizumab as measured by overall response (complete and partial response) in patients with relapsed/refractory multiple myeloma
    E.2.2Secondary objectives of the trial
    • To evaluate the safety of bevacizumab in this patient population
    • To evaluate the activity of bevacizumab on progression free survival and overall survival
    • To evaluate the activity of bevacizumab in multiple myeloma as measured by surrogate parameters of angiogenesis (bone marrow microvessel density, vascular endothelial growth factor expression by myeloma cells; serum levels of angiogenic cytokines)
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Histologically confirmed diagnosis of multiple myeloma with evaluable disease parameters. Measurable secretory disease defined as either:
    - Quantifiable serum monoclonal immunoglobulin > 1 g/dl for IgG, > 0.5 g/dl for IgA or > 0.05 g/dl for IgD
    - Measurable urine levels of Bence-Jones protein (> 200mg/24 hours)
    2. Progressive disease after 2 lines of prior therapy: This includes progressive disease after an initial response (complete, partial or minimal) to a salvage regimen or progression during such therapy. A single line of therapy may consist of one or more cytotoxic/biological agents such as melphalan plus prednisone; vincristine plus adriamycin plus dexamethasone (VAD); pulsed high-dose dexamethasone; thalidomide + dexamethasone; bortezomib. A single line of therapy is also defined as induction therapy (such as VAD) followed by high-dose melphalan with autologous stem cell transplantation plus maintenance treatment.
    Progressive disease as defined by one of the following criteria:
    - > 25% increase in M-protein
    - development of new or worsening lytic bone lesions
    - development of new or worsening plasmacytoma
    - development of new or worsening hypercalcemia despite appropriate medical treatment
    3. Age 19 – 80 years.
    4. ECOG performance status 0 or 1 or 2.
    5. Life expectancy greater than 3 months.
    6. At the time of screening, hematologic values within the following limits:
    - Absolute neutrophil count >/= 1’000/µl
    - Platelet count >/= 75’000/µl
    - Hemoglobin >/= 8.0 g/dl without transfusion support for 7 days
    7. Adequate liver function:
    - AST/ALT < 2.5 x ULN
    - Serum bilirubin < 1.5 xULN
    8. Adequate renal function:
    - Creatinine clearance of >/= 30 ml/min

    9. Urinalysis: Urine dipstick of proteinuria < 2+. Patients discovered to have >2+ proteinuria on dipstick urinalysis at baseline should undergo a 24–hour urine collection and must demonstrate < 1 g of protein / 24 hours

    10. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR, or appropriate monitoring test is within therapeutic limits and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of enrolment. Patients not receiving anti coagulant medication must have an INR </= 1.5 and aPTT </= 1.5 x ULN within 7 days of enrollment.
    11. Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to the administration of the study drug. Fertile women and men of childbearing potential (< 2 years after last menstruation in women) should prevent pregnancy (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) up to at least 6 months after last treatment completion or the last drug dose, whatever happens first.
    12. Signed written informed consent according to ICH/GCP and the local regulations (approved by the Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) will be obtained prior to any study specific screening procedures.
    13. Patient must be able to comply with the protocol
    E.4Principal exclusion criteria
    1. Non-secretory myeloma
    2. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery), or anticipation of need for major surgical procedure during the course of the study.
    3. Clinical or radiological evidence of CNS involvement or spinal cord compression.
    4. Planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed).
    5. Past or current history (within the last 5 years) of malignancies except for the indication under this study and curatively treated:
    - Basal and squamous cell carcinoma of the skin
    - In-situ carcinoma of the cervix
    6 Serious non-healing wound, ulcer or bone fracture.
    7. Evidence of any severe active acute or chronic infection.
    8. Evidence of bleeding diathesis or coagulopathy.
    9. Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤ 6 months), myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.
    10 Uncontrolled hypertension
    11. Chronic, daily treatment with aspirin (>325mg/day) or clopidogrel (>75mg/day).
    12. Treatment with any investigational drug or participation in another investigational study within 30 days prior to enrolment.
    13. Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications
    14. A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drug.
    15. HIV-positive, Hbs-antigen positive or HCV-RNA-positive patients.
    16. Pregnancy (positive serum pregnancy test) and lactation.
    E.5 End points
    E.5.1Primary end point(s)
    complete and partial response rate
    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 No
    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 Information not present in EudraCT
    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 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.8.3 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.8.5The 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    In the first stage 18 patients will be recruited, if there are less than 3 responders in the first stage recruitment will be stopped. In case of an unexpected rate of severe adverse events, the study will be closed prematurely.

    The trial ends when the last patients has performed his final visit and 6 months follow up period for targeted adverse events and when all SEAs and related adverse events have been resolved.
    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 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 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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-01-18. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 43
    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
    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 Decision2006-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-07-31
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