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    Summary
    EudraCT Number:2008-003213-27
    Sponsor's Protocol Code Number:26866138MMY3022
    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:2008-08-25
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-003213-27
    A.3Full title of the trial
    Randomized Phase III Study on Bortezomib and Low-Dose Dexamethasone with or without Continuous Low-Dose Oral Cyclophosphamide for Primary Refractory or Relapsed Multiple Myeloma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of two strategies to treat refractory or relapsed Multiple Myeloma. All patients receive Bortezomib and Dexamethasone, one half receives additional Cyclophosphamide.
    A.3.2Name or abbreviated title of the trial where available
    VelKom
    A.4.1Sponsor's protocol code number26866138MMY3022
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorORTHO BIOTECH, Division of JANSSEN-CILAG GmbH
    B.1.3.4CountryGermany
    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 supportORTHO BIOTECH Division of Janssen-Cilag GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationORTHO BIOTECH Division of Janssen-Cilag GmbH
    B.5.2Functional name of contact pointProjektleiter Dr. Carsten Gerdemann
    B.5.3 Address:
    B.5.3.1Street AddressJohnson & Johnson Platz 1
    B.5.3.2Town/ cityNeuss
    B.5.3.3Post code41470
    B.5.3.4CountryGermany
    B.5.4Telephone number00492137955 242
    B.5.5Fax number00492137955488
    B.5.6E-mailcgerdema@its.jnj.com
    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 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.3.2Product code PS-341, 26866138-AAA-PB-001
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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-[(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 to mg
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 2
    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 Endoxan
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Oncology GmbH, Kantstr. 2, 33790 Halle
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namecyclophosphamide
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCYCLOPHOSPHAMIDE
    D.3.9.1CAS number 50180
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 3
    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 Fortecortin 4 mg Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Pharma GmbH, Alsfelder Str. 17, 64289 Darmstadt
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namedexamethasone
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDEXAMETHASONE
    D.3.9.1CAS number 50022
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Refractory or relapsed multiple myeloma after 1 to 3 previous lines of therapy, including high-dose therapy
    E.1.1.1Medical condition in easily understood language
    Refractory or relapsed multiple myeloma after 1 to 3 previous lines of therapy, including high-dose therapy
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determination of efficacy as time to progression of the standard therapy of bortezomib and low dose dexamethasone in combination with or without continuous low dose oral cyclophosphamide in patients with primary refractory or relapsed myeloma (1st - 3rd relapse).
    E.2.2Secondary objectives of the trial
    Determination of
    · overall survival
    · progression free survival
    · best response rate according to IMWG 2006 criteria
    · safety
    · change in Karnofsky Performance Status Score and the quality of life by EQ-5D
    questionnaire
    · the health economic impact by rate of skeletal related events (SRE) and necessity
    for dialysis due to renal insufficiency
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female ≥18 years of age
    2. Informed consent
    3. Diagnosis of multiple myeloma and measurable disease (serum M-protein
    ≥1g/dL (10g/L, urine light-chain excretion ≥200mg/24h, involved FLC level
    ≥10mg/dL provided sFLC ratio is abnormal)
    4. Relapse or refraction of multiple myeloma following 1-3 previous lines of therapy and requires treatment. The subject has undergone or is not eligible for bone marrow transplantation.
    5. Karnofsky status ≥60%
    6. Life expectancy estimated at screening of at least 6 months
    7. Willingness or ability to comply in the investigator's opinion
    8. Women must be postmenopausal or surgically sterilized; women of childbearing
    potential must use a safe method of contraception before entry and throughout
    the study and have a negative pregnancy test at screening. Accepted is also a
    male partner vasectomized
    9. Male patients must use a reliable method of contraception from screening up to
    6 months after trial completion.
    E.4Principal exclusion criteria
    1. More than three previous lines of therapy for multiple myeloma
    2. Known allergy or hypersensitivity to bortezomib, dexamethasone and/or cyclo-
    phosphamide or to any of the constituent compounds containing boron, mannitol,
    or lactose
    3. Progressive disease or stable disease under bortezomib in a previous line of
    therapy
    4. Oligosecretory or non-secretory multiple myeloma
    5. Reception of nitrosoureas or any other chemotherapy within 6 weeks before
    enrolment
    6. Reception of corticosteroids (>10 mg/day prednisone or equivalent) within 3
    weeks before enrolment
    7. Immunotherapy or antibody therapy for multiple myeloma within 8 weeks
    before enrolment (Ig substitution therapy is not excluded)
    8. Plasmapheresis within 2 weeks before enrolment
    9. Major surgery within 4 weeks before enrolment (kyphoplasty is not considered
    major surgery)
    10. Peripheral neuropathy or neuropathic pain of grade 2 or greater intensity, as
    defined by NCI CTCAE, version 3.0
    11. Uncontrolled or severe cardiovascular disease, including myocardial infarction
    within 6 months before enrolment or NYHA Class III or IV heart failure, uncon-
    trolled angina, acute diffuse infiltrative pulmonary and pericardial disease,
    severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of
    acute ischemia, active conduction system abnormalities or cardiac amyloidosis
    12. Clinically relevant or poorly controlled vascular, pulmonary, gastrointestinal,
    endocrine, neurological, psychiatric or metabolic diseases, which could potentially
    interfere with the completion of treatment according to protocol
    subject has urinary tract obstruction or cystitis before start of therepy
    Subject has liver or renal insufficiency indicated by one or more of the following
    pre-treatment laboratory values within 14 days before and at baseline:
    · platelet count < 50×109/L (transfusion support within 14 days before the test
    is not allowed)
    · haemoglobin ≤ 7,5 g/dL
    · calculated or measured creatinine clearance < 20 mL/min
    · absolute neutrophil count (ANC) < 0,75×109/L (the use of colony stimulating
    factors within 14 days before the test is not allowed)
    · adjusted serum calcium ≥14 mg/dL (3,5 mmol/L)
    · aspartate transaminase (AST) > 2,5 × the upper limit of normal (ULN)
    · alanine transaminase (ALT) > 2,5 × ULN
    · total bilirubin > 1,5 × ULN
    13. Malignancy other than multiple myeloma within 5 years before enrolment:
    Exceptions for the following if treated and not active: basal cell or nonmetastatic
    squamous cell carcinoma of the skin, cervical carcinoma in situ or FIGO Stage 1 of
    the cervix
    14. HIV positive status. When assessed by the investigator to be at risk for HIV
    testing in accordance with local policies
    15. Positive status of hepatitis B surface antigen or known active hepatitis C. When
    assessed by the investigator to be at risk for hepatitis B or C testing in
    accordance with local regulations
    16. Systemic infection requiring treatment
    17. Use of disallowed concomitant medication
    18. Participation in other clinical studies conducted in parallel and participation in a
    clinical study, i.e. subject has received an experimental drug or used an ex-
    perimental medical device, within 30 days prior to enrolment in this study. This
    does not exclude long-term follow-up periods without drug treatment of previous
    studies.
    19. Pregnancy or breast-feeding status
    20. Previously enrolment in this study
    21. Personal or financial dependence on the investigator or the institution con-
    ducting the study
    22. Currently known known alcohol and drug abuse and/or
    dependence
    E.5 End points
    E.5.1Primary end point(s)
    Time to progression (TTP), defined as time from randomisation to first observation of disease progression, censoring for death or drop out without progression.
    Patients who died or dropped out due to any other reason without progression will be censored with the day of death or drop-out, respectively. Patients who are alive at the end of the study and have no progression will be censored with the last available date.
    For review of the primary endpoint a central expert panel will be implemented.
    E.5.1.1Timepoint(s) of evaluation of this end point
    defined as time from randomisation to first observation of disease progression, censoring for death or drop out without progression
    E.5.2Secondary end point(s)
    Overall survival, Progression free survival, Best response rate according to IMWG criteria, Safety parameters, Change in Karnofsky Index from baseline to EoT, Quality of life assessed by EQ-5D, Rate of sceletal related events, Rate of necessity for dialysis due to renal insufficiency
    E.5.2.1Timepoint(s) of evaluation of this end point
    study end, End of Treatmenmt
    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) 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    combination of bortezomib and dexamethasone with or without cyclophosphamide
    E.8.2.4Number of treatment arms in the trial2
    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 concerned32
    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 No
    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
    Last visit of last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    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.1.2.1Number of subjects for this age range: 21
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 89
    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 No
    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 state270
    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 patients have completed treatment according to the protocol there will be a follow-up phase without treatment. VELCADE is commercially available. It lies in the discretion of the investigator to decide to administer another course with VELCADE in case of relapse.
    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 Decision2008-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-01-08
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