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    Summary
    EudraCT Number:2012-002335-28
    Sponsor's Protocol Code Number:UMCGABR40641
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-07-10
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-002335-28
    A.3Full title of the trial
    Evaluation of VEGF expression with 89Zr-bevacizumab PET scan in patients with relapsing multiple myeloma; a feasibility study
    Evaluatie van VEGF expressie met 89Zr-bevacizumab PET scan in patienten met een recidief multipel myeloom, een pilot studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of protein expression with labeled-bevacizumab scan in patients with relapsing multiple myeloma.
    Evaluatie van eiwit expressie met gelabeld-bevacizumab scan in patienten met hernieuwde ziekte activiteit van het multipel myeloom.
    A.3.2Name or abbreviated title of the trial where available
    89Zr-bevacizumab PET MM
    89Zr-bevacizumab PET MM
    A.4.1Sponsor's protocol code numberUMCGABR40641
    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 SponsorUniversity medical centre groningen
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity medical centre groningen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity medical centre groningen
    B.5.2Functional name of contact pointDepartment of hematology
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31503612354
    B.5.5Fax number+31503614862
    B.5.6E-maile.g.m.de.waal@umcg.nl
    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 No
    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 name89Zr-bevacizumab
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNnot applicable
    D.3.9.1CAS number none
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive name89-Zr-sucDf-bevacizumab
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number37
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeBevacizumab is a monoclonal antibody
    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 relapsing multiple myeloma
    patienten met een recidief van het multipel myeloom
    E.1.1.1Medical condition in easily understood language
    patients with relapsing multiple myeloma
    patienten met een hernieuwde ziekte activiteit van het multipel myeloom
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In the present study we will perform a feasibility study to demonstrate that VEGF PET imaging by using 89Zr-bevacizumab as tracer can be used to detect multiple myeloma lesions
    In deze studie willen we kijken of het mogelijk is om multipel myeloma afwijking zichtbaar te maken met een PET scan waarbij gebruikt wordt gemaakt van 89Zr-bevacizumab tracer.
    E.2.2Secondary objectives of the trial
    the comparison of 89Zr-bevacizumab PET imaging with the FDG-PET scan to demonstrate whether increased angiogenesis is associated with enhanced FDG uptake. Furthermore bone marrow material will be stained to for micro vessel density (MVD) and VEGF levels. In addition we will see if there is a correlation between lesion found on the 89Zr-bevacizumab PET scan and expression of VEGF and MVD.
    Er zal een vergelijk worden gemaakt tussen 89Zr-bevacizumab PET scans en FDG-PET scans om te zien of verhoogde angiogenese ook gerelateerd is aan verhoogde FDG uptake. Daarnaast zal er op beenmergmateriaal tevens gekeken worden naar de expressie van micro vessel density (MVD) en VEGF levels en ook of er een relatie is tussen MVD en VEGF levels en de mate van afwijkingen op de 89Zr-bevacizumab PET scans.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with relapsing multiple myeloma according to international defined guidelines:

    Relapse after having achieved complete remission:
    1. Reappearance of paraprotein
    2. More than 5% plasma cells in bone marrow.
    3. New lytic lesions or progression of old lesions.
    4. New hypercalceamia.

    Relapse after having achieved partial remsission
    1. Increases of paraprotein with more than 25%
    2. Increase of urine paraprotein with more than 25%
    3. Increase of plasma cells in bone marrow with 10%
    4. New lytic lesions or progression of old lesions
    5. New hypercalceamia
    Patienten met een recidief multipel myeloom volgens de internationale richtlijnen:

    Recidief na een complete remissie:
    1. Terugkeer van het paraproteine
    2. Meer dan 5% plasma cellen in het beenmerg.
    3. Nieuwe lytische botlaesie of toename van oude laesies.
    4. Nieuwe hypercalceamie

    Recidief na een partiele remissie
    1. Toename van paraproteinemet meer dan 25%
    2. Toename van urine paraproteinemet meer dan 25%
    3. Toename van plasma cellen in het beenmerg met 10%
    4. Nieuwe lytische botlaesie of toename van oude laesies
    5. Nieuwe hypercalceamie
    E.4Principal exclusion criteria
    - Radiotherapy in the last 3 months.
    - Ineligible to lay supine during the PET scan.
    - Age ≤18 years.
    - Pregnancy.
    - Claustrophobia
    - Severe kidney dysfunction; serum-creatinine ≥250 µM
    - Radiotherapie in de laatste 3 maanden.
    - Onmogelijkheid om plat te liggen in de PET scan.
    - Leeftijd ≤18 jaar.
    - Zwangerschap.
    - Claustrofobie
    - Ernstige nierfunctiestoornis; serum-kreatinine ≥250 µM
    E.5 End points
    E.5.1Primary end point(s)
    89Zr-bevacizumab tracer uptake in multiple myeloma lesions
    89Zr-bevacizumab tracer uptake in multipel myeloom afwijkingen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    89Zr-bevacizumab tracer uptake in multiple myeloma lesions
    89Zr-bevacizumab tracer uptake in multipel myeloom afwijkingen
    E.5.2Secondary end point(s)
    • The correlation between positive lesions found on the FDG-PET and lesions found on 89Zr-bevacizumab PET.
    • The correlation between VEGF levels and MVD in bone marrow samples of multiple myeloma patients and lesions found on 89Zr-bevacizumab PET.
    • The correlatie tussen positieve afwijkingen op de FDG-PET scan en afwijkingen gevonden op de 89Zr-bevacizumab PET scan.
    • The correlatie tussen VEGF levels and MVD in beenmergmateriaal van multipel myeloom patienten en afwijkingen op de 89Zr-bevacizumab PET scan.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The scans and bone marrow samples will be evaluated directly (after they are peformed).
    Direct na verrichten van de scans en de kleuring van het beenmerg zullen de resultaten bekeken worden.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    The end of the trail will be when20 patients with relapsing myeloma are included.
    De studie is afgerond als er 20 patienten met een recidief multipel myeloom geincludeerd zijn.
    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 months6
    E.8.9.1In the Member State concerned 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 20
    F.4.2.2In the whole clinical trial 20
    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)
    none
    geen
    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 Decision2012-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-07
    P. End of Trial
    P.End of Trial StatusOngoing
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