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    Summary
    EudraCT Number:2011-000366-35
    Sponsor's Protocol Code Number:RG_09-121
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-08-05
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-000366-35
    A.3Full title of the trial
    Tackling Early Morbidity and Mortality in myeloma: assessing the benefit of antibiotic prophylaxis and its effect on healthcare associated infections
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tackling early deaths and assessing quality of life in patients with myeloma: assessing the effect of preventative antibiotics on healthcare associated infections
    A.3.2Name or abbreviated title of the trial where available
    TEAMM: Tackling early morbidity and mortality in myeloma
    A.4.1Sponsor's protocol code numberRG_09-121
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN51731976
    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 of Birmingham
    B.1.3.4CountryUnited Kingdom
    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 supportNIHR HTA
    B.4.2CountryUnited Kingdom
    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
    B.Sponsor: 2
    B.1.1Name of SponsorUniversity of Warwick
    B.1.3.4CountryUnited Kingdom
    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 supportNIHR HTA
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Warwick, Clinical Trials Unit
    B.5.2Functional name of contact pointProfessor Janet Dunn
    B.5.3 Address:
    B.5.3.1Street AddressGibbet Hill Road
    B.5.3.2Town/ cityCoventry
    B.5.3.3Post codeCV4 7AL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02476575847
    B.5.5Fax number02476151586
    B.5.6E-mailJ.A.Dunn@warwick.ac.uk
    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 Prixoter 250mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderPharmathen S.A.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameLevofloxacin
    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 INNLevofloxacin
    D.3.9.1CAS number 100986-85-4
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number125 to 500
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Infections during early symptomatic multiple myeloma
    E.1.1.1Medical condition in easily understood language
    Cancer of bone marrow
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10028566
    E.1.2Term Myeloma
    E.1.2System Organ Class 100000004864
    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 risks, benefits and cost effectiveness of levofloxacin in newly diagnosed symptomatic myeloma by a prospective, multi-centre, randomised, double-blind, placebo-controlled trial.
    E.2.2Secondary objectives of the trial
    n/a
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥ 21 years and able to give informed consent
    • Patient with newly diagnosed symptomatic myeloma based on internationally agreed criteria, within 7 days of starting a program of anti-myeloma therapy (or within 14 days of starting anti-myeloma therapy if already on a broad spectrum antibacterial agent)
    • Provision of written informed consent
    E.4Principal exclusion criteria
    Patients with the following characteristics are ineligible for this trial:
    • Patients with contraindication to Levofloxacin:-
     known to have sensitivity / allergy to Levofloxacin or other quinolones
     Patients with a history of tendon disorders related to fluoroquinolone administration
     Patients receiving amiodarone or arsenic trioxide
     Patients on active antiepileptic treatment
    • Women of childbearing age who are not willing to use appropriate methods of contraception to prevent pregnancy or women that are breastfeeding
    • Patient thought to have mandatory requirement for antibacterial prophylaxis (with the exception of pneumocystis prophylaxis if regarded as essential)
    • Previous treatment for myeloma, except for the following:
     Local radiotherapy to relieve bone pain or spinal cord compression
     Prior bisphosphonate treatment
    • Previous (<5 years since diagnosis) or concurrent active malignancies except surgically removed basal or squamous cell carcinoma of the skin, treated carcinoma insitu of the breast or cervix, or incidental histologic finding of prostate cancer (TNM stage of T1a or 1b). Patients with remote histories (>5 years) of other cured malignancies may be entered.
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome from start of trial treatment to 12 weeks
    • Time to first febrile episode. A febrile episode is identified and counted by:
    • A single oral temperature ≥38° C (recorded EITHER by a health care professional OR by the patient/carer provided that the patient/carer has been trained and assessed as competent in temperature taking) AND that the patient is then given anti-infectives
    • A single febrile episode is defined as the initial febrile event and any subsequent fevers until that course of anti-infectives have been stopped
    • Capture of Febrile episodes will be via 1) documentation in hospital and 2) via patient diary cards. Patient diary cards will form part of the CRF returned four weekly.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Number of febrile episodes will be assessed at 4 weekly intervals up to 12 weeks. Patients will complete a daily diary with their oral temperature. This alongside any hospital documentation detailing febrile episodes within each of the 4 week periods will be summarised at 12 weeks. Patients will stop taking the trial drug at 12 weeks. Febrile episodes will be monitored actively up to 16 weeks.
    E.5.2Secondary end point(s)
    Secondary outcomes from start of trial treatment to 12 weeks
    • Carriage and invasive infections with S. aureus, C. difficile and ESBL coliforms between 12 and 16 weeks to assess for delayed affects from the intervention that is stopped at 12 weeks
    • Response to anti-myeloma therapy at 16 weeks. Because of the half life of paraproteins measurement of myeloma response cannot be undertaken until a minimum of 4 weeks after an intervention
    • Quality of life (4 weekly questionnaires up to 16 weeks)
    • Health economics (daily diary card which captures elements of health resource use in combination with information captured on the CRF)
    • Overall survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    Carriage and invasive infections with S.aureus, C. difficile and ESBL coliforms will be evaluated up to 16 weeks from start of trial treatment. This will be via samples collected 4 weekly until 16 weeks.

    Response to anti-myeloma therepy will be evaluated at 16 weeks post start of trial treatment.

    Quality of life will be evaluated 4 weekly until 16 weeks post start of trial treatment

    Health econmics questions will be delivered to patients daily via a patient diary card. These will be summarised and evaluated 4 weekly up until 16 weeks

    Overall survival will be evaluated at the end of the trial rather than the end of the treatment period.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned110
    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 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
    The end of the trial is the last visit if the last subject undergoing the trial drug treatment and questionnaires. The end of the treatment period is at 16 weeks when all patients have received their 12 weeks medication and had their end of treatment assessment. Patients will have 1 12 month follow-up appointment. The study will continue to assess patients at regular intervals and then flagged for long-term follow-up until death.
    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 months8
    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 months8
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 state1000
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1000
    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)
    n/a
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Myeloma UK
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-06
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