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    EudraCT Number:2006-001709-27
    Sponsor's Protocol Code Number:26866138MMY2038
    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:2006-06-29
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedLithuania - SMCA
    A.2EudraCT number2006-001709-27
    A.3Full title of the trial
    A Phase 2, Multicentre, Randomised, Open-Label, Parallel Group Study to Evaluate the Safety and Efficacy of Velcade® when added to Adriamycin-Dexamethasone Treatment versus Vincristine-Adriamycin-Dexamethasone Standard Treatment in Subjects with Multiple Myeloma who are Refractory to or Have Relapsed after Primary Therapy for Multiple Myeloma.
    A.3.2Name or abbreviated title of the trial where available
    PAD versus VAD in 2nd line multiple myeloma
    A.4.1Sponsor's protocol code number26866138MMY2038
    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.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.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. name VELCADE
    D. of the Marketing Authorisation holderJanssen-Cilag International N.V.
    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.3.1Product 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 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 9.0
    E.1.2Level LLT
    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 assess the safety and efficacy of replacing vincristine with Velcade® (bortezomib, also named PS341) in the standard therapy vincristine, adriamycin and dexamethasone (VAD) in subjects with multiple myeloma who are refractory to or have relapsed after their primary therapy for multiple myeloma. The efficacy response will be measured by the response rate of the disease.
    E.2.2Secondary objectives of the trial
    To assess the duration of response, event free survival, the time to progression, the one year survival and the overall survival of the subjects treated with Velcade® in combination with the adriamycin and dexamethasone (PAD) therapy versus the VAD standard therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subject, aged >= 18 years.
    2. The 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 his or her 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 e 200 mg/24 hours.
    4. The subject has relapsed or is refractory for multiple myeloma following 1 previous line of therapy and is scheduled by the investigator to be treated with vincristine, adriamycin and dexamethasone (VAD) combination treatment. PD or relapse are defined as one or more of the following criteria:
    Criteria for PD:
    Criteria for PD for subjects not in CR
    ·>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.
    5.Subject has a Karnofsky performance status of >= 60 (see Attachment 1: Karnofsky Performance Status Scale).
    6. Subject has a life expectancy estimated at screening of at least 6 months.
    7. The subject meets the following pretreatment laboratory criteria at and within 14 days before baseline (Day 1 of Cycle 1, before study drug administration):
    -platelet count >= 50x 109/L;
    -haemoglobin >7.5 g/dl without transfusion support within 7 days before the test;
    -creatinine clearance >= 20 mL/min (calculated or measured, see Attachment 2: Creatinine Clearance Calculation for formula).
    -absolute neutrophil count (ANC) >= 0.75 x 10 9/L without the use of colony stimulating factors.

    -corrected serum calcium < 14 mg/dL (3.5 mmol/L).
    -aspartate transaminase (AST): <= 2.5 x the upper limit of normal (ULN).
    -alanine transaminase (ALT): <= 2.5 x ULN.
    -total bilirubin: <= 1.5 x ULN.
    8. The subject is, in the investigators opinion, willing and able to comply with the protocol requirements.
    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. Subject received more than one previous line of therapy for multiple myeloma.
    2. Subject has known allergy or hypersensitivity to bortezomib, boron or mannitol.
    3. Use of Velcade® in the previous line of therapy and/or the subject received Velcade® in a previous trial.
    4. Subject has oligosecretory or non-secretory multiple myeloma.
    5. Subject received nitrosoureas or any other chemotherapy (including thalidomide), clarithromycin, interferon within 6 weeks.
    6. Subject received corticosteroids (> 10 mg/day prednisone or equivalent) within 3 weeks before enrolment.
    7. Subject received immunotherapy or antibody therapy within 8 weeks before enrolment.
    8. Subject received plasmapheresis within 4 weeks before enrolment.
    9. Subject had major surgery within 4 weeks before enrolment (kyphoplasty was not considered major surgery).
    10. Subject has peripheral neuropathy or neuropathic pain of grade 2 or greater intensity, as defined by the National Cancer Institute Common Terminology Criteria of Adverse Events (NCI CTCAE), version 3.0 (see Attachment 6 for link).
    11. Subject had a myocardial infarction within 6 months of enrolment or had New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
    12. 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.
    13. Subject was treated for a cancer other than multiple myeloma within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ.
    14. 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.
    15. Subject was known to be hepatitis B surface antigen-positive or had known active hepatitis C infection. (Subjects assessed by the investigator to be at risk for hepatitis B or C infection are to be tested in accordance with local regulations.)
    16. Subject had an active systemic infection requiring treatment.
    17. Subject uses disallowed medication (see section 8.2).
    18. Subject has received an experimental drug or used an experimental medical device within 4 weeks before enrolment.
    19. If female, the subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum pregnancy test at screening. Pregnancy testing is not required for postmenopausal or surgically sterilised women.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is Response Rate as defined by the combination of subjects with CR and PR according to the EBMT (European Group for Blood and Marrow Transplantation) criteria. It will be analysed by a stratified Mantel-Hanszel test at a 2-sided level where a = 5%. The stratification variables will be primary therapy (high dose versus conventional dose therapy and whether or not stem cells were transplanted), age groups and country.
    The primary analysis will be based on the best response obtained during the treatment period.
    Subjects who discontinue the treatment period without reaching a PR or CR will be analysed as non-responders.
    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. 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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    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 concerned3
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    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 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 2006-06-29. 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 195
    F.4.2.2In the whole clinical trial 212
    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 Decision2006-09-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-01-18
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