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    Summary
    EudraCT Number:2005-005819-26
    Sponsor's Protocol Code Number:26866138-MMY-2036
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-25
    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 ConcernedSpain - AEMPS
    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 EMEA Medical Affairs
    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 Information not present in EudraCT
    D.2.1.1.1Trade name VELCADE
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International N.V.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameVELCADE 3.5 mg powder for solution for injection
    D.3.2Product code PS-341, 26866138-AAA-PB-001
    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/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.3
    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 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 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.1.2Classification code 10028228
    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 DOR and TTP.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Male or female subject, aged >= 18 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 has 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 0.5g/dL immunoglobulin A (IgA)) or urine light-chain excretion of >= 200 mg/24 hours.
    4. Subject previously tolerated 1.0 or 1.3 mg/m2/dose of VELCADE alone or in combination with other agents and had CR or PR upon completion of VELCADE therapy.
    5. It has been >= 6 months 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 >=60% (see Attachment 1: Karnofsky Performance Status Scale).
    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 >=7.5 g/dL without transfusion support within 7 days before the test;
    · Absolute neutrophil count (ANC) >=0.75 x 10 exp.9/L without the use of growth factors;
    · Corrected serum calcium <14 mg/dL (3.5 mmol/L);
    · Aspartate aminotransferase (AST) <=2.5 x the upper limit of normal (ULN);
    · Alanine aminotransferase (ALT) <=2.5 x the ULN;
    · Total bilirubin <=1.5 x the ULN; and
    · Calculated or measured creatinine clearance >=20 mL/minute (see Attachment 2: Creatinine Clearance Calculation for formula to calculate clearance from serum creatinine).
    9. If female, the subject is either postmenopausal or surgically sterilised or willing to use an acceptable method of birth control (i.e., total abstinence - periodic abstinence can not be allowed -, a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide) 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 contraception from screening through at least 30 days after completion of the last treatment cycle.
    E.4Principal exclusion criteria
    1. Subjects 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 their last dose of VELCADE. Note: Subjects can have received localized palliative radiotherapy for complications due to osteolytic bone lesions. Subjects can have received steroids (cumulative exposure of up to 160 mg of 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 a CR or PR but relapsed 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 a history of allergic reaction to VELCADE or attributable to compounds containing boron or mannitol.
    7. Subject has peripheral neuropathy or neuropathic pain of >= Grade 2, as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0.
    8. Subject has cardiac amyloidosis.
    9. Subject has an uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months of enrolment or had New York Heart Association (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 for the following 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 human immunodeficiency virus (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 infection. (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 pregnant or breast feeding. Confirmation that the subject is not pregnant must be established by a negative serum B-HCG pregnancy test result obtained during the Screening period. Pregnancy testing is not required for post-menopausal
    16. Subjects that have been previously enrolled in this trial
    17. Subjects that have taken any experimental therapy or used any experimental device within 30 days prior to the enrolment.
    E.5 End points
    E.5.1Primary end point(s)
    To determine best response to VELCADE re-treatment in multiple myeloma subjects who have previously responded 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 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 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 Yes
    E.8.1.7.1Other trial design description
    single arm
    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.8.5The 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 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
    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 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.1.3Elderly (>=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 No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 125
    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 Decision2006-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-08
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