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    Summary
    EudraCT Number:2005-005819-26
    Sponsor's Protocol Code Number:26866138-MMY-2036
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-09-27
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-005819-26
    A.3Full title of the trial
    A Phase II, Open-Label Trial Using VELCADE for Re-Treatment of Multiple Myeloma Subjects Following an Initial Response to VELCADE
    A.4.1Sponsor's protocol code number26866138-MMY-2036
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 Yes
    D.2.1.1.1Trade name VELCADE 3,5 mg Pulver zur Herstellung einer Injektionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 for solution for injection
    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 INNbortezomib
    D.3.9.1CAS number 179324-69-7
    D.3.9.2Current sponsor code26866138
    D.3.9.3Other descriptive nameBoronic Acid: [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2[(pyrazinylcarbonyl)amino]propyl]amino]butyl
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3,5
    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) 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 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
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine best response to VELCADE re-treatment in multiple myeloma subjects who have previously responded to a VELCADE based therapy.
    E.2.2Secondary objectives of the trial
    · Determine the incidence of SAEs, Grade 3 and 4 AEs, and all grades of neuropathy
    from each subject at baseline and every 6 weeks during treatment.
    · Determine best confirmed M-protein response to VELCADE re-treatment in multiple
    myeloma subjects who have previously responded to VELCADE.
    · Determine the duration of response and time to progression.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subject, aged 18 or more years.
    2. Subject has given voluntary written informed consent before performance of any
    study related procedure not part of normal medical care, with the understanding
    that consent may be withdrawn by the subject at any time without prejudice to
    future medical care.
    3. Subject was previously diagnosed with multiple myeloma based on standard
    criteria and measurable disease. Measurable disease for secretory multiple
    myeloma is defined as any quantifiable serum monoclonal protein value
    (generally, but not exclusively, greater than 1 g/dl of immunoglobulin G (IgG)
    M-Protein and greater than 0,5 g/dl immunoglobulin A (IgA) or urine light-chain
    excretion of 200 mg or more in 24 hours.
    4. Subject previously tolerated 1,0 or 1,3 mg/m²/dose of VELCADE alone or in com-
    binationwith other agents and CR or PR upon completion of VELCADE therapy.
    5. It has been 6 months or more since the subject's last VELCADE dose and the
    subject has Progressive Disease (PD) if prior response to VELCADE was PR or
    subject has relapsed from CR. PD or relapse are defined as one or more of the
    following criteria: Criteria for PD for subjects that had PR to previous VELCADE
    course:
    - >25% increase in either serum or urine M-protein;·
    - >25% increase in plasma cells on bone marrow;
    - Definite increase in size of bone lesion or plasmacytoma;
    - Development of new bone lesion or plasmacytoma; or
    - Development of hypercalcemia (corrected serum calcium >11,5 mg/dl or
    2,8 mmol/l) not attributable to other causes.
    Criteria for relapse from CR:
    - Reappearance of serum or urinary paraprotein on immunofixation or routine
    electrophoresis, confirmed by at least one further investigation and excluding
    oligoclonal immune reconstitution
    - >5% plasma cells in bone marrow aspirate or on trephine bone biopsy
    - Development of new lytic bone lesions or soft tissue plasmacytomas or definite
    increase in the size of residual bone lesions
    - Development of hypercalcemia (corrected serum calcium >11,5 mg/dl or
    2,8 mmol/l) not attributable to any other cause.
    6. Subject has a Karnofsky performance status of 60% or more.
    7. Subject has a life-expectancy >3 months.
    8. Subject has the following laboratory values within 14 days before enrolment
    (Day 1, Cycle 1, before drug administration):
    - Platelet count >=50 x 10 exp. 9/l without transfusion support within the 7 days
    before the test;
    - Hemoglobin of 7,5 g/dl or more without transfusion support within 7 days
    before the test;
    - Absolute neutrophil count (ANC) 0,75 x 10 exp.9/l ore more without the use of
    growth factors within 14 days before the test;
    - Corrected serum calcium <14 mg/dl (3,5 mmol/l);
    - Aspartate aminotransferase (AST) 2,5 x the upper limit of normal (ULN) or less;
    - Alanine aminotransferase (ALT) 2,5 x the ULN or less;
    - Total bilirubin 1,5 x the ULN or less;
    - Calculated or measured creatinine clearance 20 ml/minute or more
    9. If female, the subject is either postmenopausal or surgically sterilised or willing
    to use an acceptable method of birth control from screening through at least 30
    days after completion of the last treatment cycle.
    10. If male, the subject agrees to use an acceptable barrier method for contra-
    ception from screening through at least 30 days after completion of the last
    treatment cycle.
    E.4Principal exclusion criteria
    1. Subject with a history of PD, minimal response, or stable disease (SD) on last
    exposure to VELCADE.
    2. Subject has received chemotherapy, radiotherapy, antibody, immunotherapy, or
    experimental therapy to treat multiple myeloma since last dose of VELCADE.
    Note: Subjects can have received localized palliative radiotherapy for
    complications due to osteolytic bone lesions. Subjects can have received steroids
    (dexamethasone or equivalent) or thalidomide or interferon as maintenance
    therapy since their last dose of VELCADE. Subjects can have received high dose
    therapy/stem cell transplantation after VELCADE containing induction regimen,
    only if PR or CR was observed during VELCADE containing induction therapy.
    3. Subjects who achieved CR or PR but relapse while on therapy.
    4. Subject has oligosecretory or non-secretory multiple myeloma.
    5. Subject had major surgery within 4 weeks before enrolment. (Kyphoplasty is not
    considered major surgery.)
    6. Subject has history of allergic reaction to VELCADE or compounds containing
    boron or mannitol.
    7. Subject has peripheral neuropathy or neuropathic pain of Grade 2 or higher, as
    defined by NCI CTCAE Version 3.0.
    8. Subject has cardiac amyloidosis.
    9. Subject has an uncontrolled or severe cardiovascular disease, including myo-
    cardial infarction within 6 months of enrolment or has NYHA class III or IV heart
    failure, uncontrolled angina, clinically significant pericardial disease, severe
    uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
    ischemia or active conduction system abnormalities.
    10. Subject has poorly controlled hypertension, diabetes mellitus, or other serious
    medical or psychiatric illness that could potentially interfere with the completion
    of treatment according to this protocol.
    11. Subject had another malignancy within the past 5 years. Exceptions if treated
    and not active:
    basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical
    carcinoma in situ or International Federation of Gynecology and Obstetrics
    (FIGO) Stage 1 carcinoma of the cervix.
    12. Subject is known to be HIV-positive (Subjects assessed by the investigator to be
    at risk for HIV infection should be tested in accordance with local policies).
    13. Subject is known to be hepatitis B surface antigen-positive or has known active
    hepatitis C. (Subjects assessed by the investigator to be at risk for hepatitis B or
    C infection should be tested in accordance with local policies).
    14. Subject has an active systemic infection requiring treatment.
    15. Female subject is gregnant or breast feeding. Confirmation that the subject is
    not pregnant must be established by a negative B-HCG pregnancy test result
    obtained during the Screening period. Pregnancy testing is not required for post-
    menopausal or surgically sterilized women.
    16. Subjects that have been previously enrolled in this trial
    17. Subjects that have taken an experimental therapy or used any experimental
    device within 30 days prior to enrolment.
    E.5 End points
    E.5.1Primary end point(s)
    Determination of best response to VELCADE re-treatment in multiple myeloma with previous response to a VELCADE based therapy.
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    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 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
    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 months6
    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 months6
    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 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 2006-09-27. Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 125
    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)
    After the longterm follow-up (end of the clinical trial) the patient must not be treated further on, as long as there is no relapse. In case of relapse, the patient can receive a standard therapy of choice at the treating doctor's own discretion.
    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 Decision2006-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-08
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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