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    Summary
    EudraCT Number:2004-001178-13
    Sponsor's Protocol Code Number:26866138-MMY-3001
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-11-30
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2004-001178-13
    A.3Full title of the trial
    An International Single-Arm Protocol to Provide Expanded Access to VELCADE(TM) for Patients With Multiple Myeloma Who Have Received at Least Two Previous Lines of Therapy and are Refractory to or Have Relapsed After Their Last Therapy for Multiple Myeloma
    A.3.2Name or abbreviated title of the trial where available
    Expanded Access Program to VELCADE(TM) (EAP)
    A.4.1Sponsor's protocol code number26866138-MMY-3001
    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 N.V.
    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 NV
    D.2.1.2Country which granted the Marketing AuthorisationLithuania
    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 nameVELCADE3,5 mg powder for solution for injection
    D.3.2Product code PS-341
    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.3.9.3Other descriptive nameBoronic Acid: [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    Patients with multiple myeloma who have received at least 2 previous lines of therapy and are refractory to or have relapsed after their last therapy for 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
    The primary objective is to provide VELCADE to patients with multiple myeloma who have received at least 2 previous lines of therapy and are refractory to or have relapsed after their last therapy for multiple myeloma.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the safety and tolerability of VELCADE and to follow monoclonal paraprotein (M-protein) levels in patients receiving VELCADE as a measure of disease burden.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    The patient was previously diagnosed with multiple myeloma based on standard criteria.
    The patient has received at least 2 previous lines of therapy for multiple myeloma and, in the investigators opinion, is refractory to or has relapsed after the last therapy.
    The patient is of a legally consenting age, as defined by local regulations, and is >18 years of age.
    The patient is, in the investigators opinion, willing and able to comply with the protocol requirements.
    The patient has given voluntary written informed consent before performance of any studyrelated procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to his or her future medical care.
    If female, the patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) from Screening through the Final Visit.
    If male, the patient agrees to use an acceptable barrier method for contraception from Screening through the Final Visit.
    The patient has a Karnofsky performance status >60 (see Attachment 1).
    The patient meets the following pretreatment laboratory criteria at and within 21 days before baseline (Day 1 of Cycle 1, before study drug administration):
    Platelet count >30x 109/L, with or without transfusion support.
    Hemoglobin >7.0 g/dL, with or without transfusion support
    Absolute neutrophil count (ANC) >0.5 x 109/L.
    Serum calcium <3.5 mmol/L (14 mg/dL).
    Aspartate transaminase (AST): <2.5 x the upper limit of normal (ULN).
    Alanine transaminase (ALT): <2.5 x the ULN.
    Total bilirubin: <1.5 x the ULN.
    Calculated (see Attachment 2) or measured creatinine clearance:
    >30 mL/minute.
    E.4Principal exclusion criteria
    If the patient received VELCADE in a previous clinical trial, the patients best response to VELCADE was progressive disease.
    If the patient received VELCADE in a previous trial, the patient experienced one or more serious adverse events.
    Patient received nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks before enrollment.
    Patient received corticosteroids (>10 mg/day of prednisone or equivalent) within 3 weeks before enrollment.
    Patient received immunotherapy or antibody therapy within 4 weeks before enrollment.
    Patient has received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment.
    Patient had major surgery within 4 weeks before enrollment. (Kyphoplasty is not considered major surgery.)
    Patient has a history of allergic reaction attributable to compounds containing boron or mannitol.
    Patient has peripheral neuropathy of Grade 2 or greater intensity, as defined by the NCI Common Toxicity Criteria (NCI CTC), as follows: Grade 2: Objective sensory loss or paresthesia (including tingling), interfering with function, but not interfering with activities of daily living (ADLs); Grade 3: Sensory loss or paresthesia interfering with ADLs; Grade 4:Permanent sensory loss that interferes with function.
    Patient had a myocardial infarction within 6 months of enrollment or has New NYHA Class III or IV heart failure uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
    Patient has cardiac amyloidosis.
    Patient 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.
    Patient known to be HIV-positive.
    Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection.
    Patient has an active systemic infection requiring treatment.
    If female, the patient is pregnant or breast-feeding. Confirmation that the patient is not pregnant must be established by a negative serum -hCG pregnancy test during Screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
    E.5 End points
    E.5.1Primary end point(s)
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) 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 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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 750
    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 Decision2005-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-04-20
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