Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43889   clinical trials with a EudraCT protocol, of which   7298   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-005110-58
    Sponsor's Protocol Code Number:64024
    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:2018-05-14
    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 number2017-005110-58
    A.3Full title of the trial
    Efficacy of a predefined vitamin D dosing regimen in vitamin D-insufficient multiple myeloma patients.
    Effectiviteit van een vooraf gedefinieerd vitamine D-doseringsschema bij patiënten met vitamine D-insufficiëntie bij multipel myeloom.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of vitamin D supplementation in multiple myeloma patients.
    Effectiviteit van vitamine D-suppletie bij patiënten met multipel myeloom.
    A.3.2Name or abbreviated title of the trial where available
    Efficacy of vitamin D supplementation in multiple myeloma patients.
    Effectiviteit van vitamine D-suppletie bij patiënten met multipel myeloom.
    A.4.1Sponsor's protocol code number64024
    A.5.4Other Identifiers
    Name:Nederlands Trial RegisterNumber:NTR28251
    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 SponsorMedical Centre Leeuwarden
    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 supportMedical Centre Leeuwarden
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical Centre Leeuwarden
    B.5.2Functional name of contact pointBerdien Oortgiesen
    B.5.3 Address:
    B.5.3.1Street AddressPostbus 888
    B.5.3.2Town/ cityLeeuwarden
    B.5.3.3Post code8901 BR
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310582861918
    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 Cholecalciferol Mylan 800 IU tablets
    D.2.1.1.2Name of the Marketing Authorisation holderMylan B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameCholecalciferol Mylan 800 IE tablets
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 D-Cura 100.000 IU oral solution
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires SMB S.A.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Oral solution in single-dose container
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Hypovitaminosis D
    Hypovitaminose D
    E.1.1.1Medical condition in easily understood language
    vitamin D-insufficiency
    vitamine D-insufficiëntie
    E.1.1.2Therapeutic area Body processes [G] - Cell Physiological Phenomena [G04]
    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
    The primary objective of this study is to determine the efficacy of a predefined vitamin D dosing regimen on the prevalence of vitamin D insufficiency in MM patients.
    Het primaire doel van dit onderzoek is het bepalen van de effectiviteit van een vooraf gedefinieerd vitamine D-doseringsschema op de prevalentie van vitamine D-insufficiëntie bij patiënten met multipel myeloom.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to detect the influence of several variables (age, gender, cumulative dose, type of treatment, race, the use of alcohol and the presence of diabetes mellitus) on the chance of successfully increasing the vitamin D serum concentration; to determine the efficacy of vitamin D supplementation on the prevalence and severity of PN in MM patients; to determine differences between the effect of vitamin D supplementation on the prevalence and severity of PN for each subgroup: treatment and different drugs used for MM (drugs that can be used are bortezomib, carfilzomib, daratumumab, elotuzumab, ixazomib, lenalidomide, panobinostat, pomalidomide, thalidomide and vincristine).
    Secundaire doelen zijn het detecteren van de invloed van verschillende variabelen (leeftijd, geslacht, cumulatieve dosis, type behandeling, ras, het gebruik van alcohol en de aanwezigheid van diabetes mellitus) op de kans op het succesvol verhogen van de vitamine D-serumconcentratie; het bepalen de effectiviteit van vitamine D-suppletie op de prevalentie en ernst van perifere neuropathie in MM patiënten; het bepalen van verschillen in het effect van vitamine D-suppletie op de prevalentie en ernst van perifere neuropathie voor elke sungroep: behandeling en elk geneesmiddel dat bij multipel myeloom gebruikt wordt (bortezomib, carfilzomib, daratumumab, elotuzumab, ixazomib, lenalidomide, panobinostat, pomalidomide, thalidomide en vincristine).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects are (newly) diagnosed with smoldering or symptomatic multiple myeloma. Subjects must be over 18 years of age. Subjects must be able to give informed consent. Subjects with a 25-hydroxyvitamin D level ≤75 nmol/l.
    Patiënten die (nieuw) gediagnosticeerd zijn met asymptomatisch of symptomatisch multipel myeloom. Patiënten die 18 jaar of ouder zijn. Patiënten die in staat zijn om informed consent te geven. Patiënten met een 25-hydroxyvitamine D-spiegel ≤75 nmol/l
    E.4Principal exclusion criteria
    Contraindications for the use of vitamin D: Hypersensitivity to the active substance(s) or to any of the excipients; Hypercalcaemia and/or hypercalciuria; Nephrolithiasis and/or nephrocalcinosis; Serious renal impairment; Hypervitaminosis D; Pseudohypoparathyroidism.
    The use of vitamin D tablets or multivitamin tablets containing vitamin D
    Contra-indicaties voor het gebruik van vitamine D: Overgevoeligheid voor een actief bestanddeel of een hulpsstof; Hypercalcemie en/of hypercalciurie; Nephrolithiasis en/of nephrocalcinosis; Ernstige nierinsufficiëntie; Hypervitaminose D; Pseudohypoparathyroidisme.
    Het gebruik van vitamine D tabletten of multivitamine tabletten die vitamine D bevatten
    E.5 End points
    E.5.1Primary end point(s)
    The main endpoint is the proportion of patients with an adequate vitamin D level (> 75 nmol/L) after 6 months.
    De primaire uitkomstmaat is de proportie patiënten met aan adequaat vitamine D-level (> 75 nmol/l) na 6 maanden.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 months
    Na 6 maanden
    E.5.2Secondary end point(s)
    Secondary endpoints are the influence of several variables (age, gender, cumulative dose, type of treatment, race, the use of alcohol and the presence of diabetes mellitus) on the chance of successfully increasing the vitamin D serum concentration; the efficacy of vitamin D supplementation on the prevalence and severity of PN in vitamin D-deficient MM patients; differences between the effect of vitamin D supplementation on the prevalence and severity of PN for each subgroup: treatment and different drugs used for MM (drugs that can be used are bortezomib, carfilzomib, daratumumab, elotuzumab, ixazomib, lenalidomide, panobinostat, pomalidomide, thalidomide and vincristine)
    Secundaire eindpunten zijn de invloed van verschillende variabelen (leeftijd, geslacht, cumulatieve dosis, type behandeling, ras, het gebruik van alcohol en de aanwezigheid van diabetes mellitus) op de kans op het succesvol verhogen van de vitamine D-serumconcentratie; de effectiviteit van vitamine D-suppletie op de prevalentie en ernst van perifere neuropathie in vitamine D-deficiënte multipel myeloom patiënten; verschillen in het effect van vitamine D suppletie op de prevalentie en ernst van perifere neuropathie voor elke subgroep: behandeling en elk geneesmiddel dat bij multipel myeloom gebruikt wordt (bortezomib, carfilzomib, daratumumab, elotuzumab, ixazomib, lenalidomide, panobinostat, pomalidomide, thalidomide en vincristine).
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 6 months
    Na 6 maanden
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 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 concerned2
    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
    LVLS
    Laatste bezoek van laatste patiënt
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 29
    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 state40
    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)
    Patients may decide to continue the use of vitamin D at the end of the study in consultation with their physician.
    Patiënten mogen aan het einde van het onderzoek in overleg met de arts besluiten om het vitamine D-gebruik te continueren.
    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 Decision2018-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-14
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 25 18:09:38 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA