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    Summary
    EudraCT Number:2018-003258-25
    Sponsor's Protocol Code Number:X16120
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-03-22
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2018-003258-25
    A.3Full title of the trial
    Bone Study
    Bone Healing During Ninlaro Exposure.
    An open label phase 2 single centre clinical trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Bone Study
    Bone healing during Ninlaro treatment.
    A.4.1Sponsor's protocol code numberX16120
    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 SponsorOdense University Hospital
    B.1.3.4CountryDenmark
    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 supportOdense University Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOdense University Hospital
    B.5.2Functional name of contact pointOdense University Hospital
    B.5.3 Address:
    B.5.3.1Street AddressSdr. boulevard 29
    B.5.3.2Town/ cityOdense C
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4565411156
    B.5.5Fax number+4565413031
    B.5.6E-mailbirgitte.wolf.lundholm@rsyd.dk
    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 Ninlaro
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameNinlaro
    D.3.2Product code EMEA/H/C/003844
    D.3.4Pharmaceutical form Capsule
    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 INNIxazomib
    D.3.9.1CAS number 1072833-77-2
    D.3.9.3Other descriptive nameIXAZOMIB
    D.3.9.4EV Substance CodeSUB121332
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    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
    multiple myeloma
    Myelomatose
    E.1.1.1Medical condition in easily understood language
    multiple myeloma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the study is to investigate if treatment with ixazomib can cause healing of preexisting osteolytic bone lesions in Multiple Myeloma.
    E.2.2Secondary objectives of the trial
    Increased bone formation during Ixazomib treatment in NaF PET. Increased bone anabolism during Ixazomib treatment. Increased bone formation to bone degradation ratio during Ixazomib treatment. Increased bone formation using bone histomorphometric evaluation. Investigate safety and toxicities during Ixazomib treatment. Depth of cancer response to Ixazomib treatment. Adherence to therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Symptomatic Multiple Myeloma according to the IMWG criteria.

    • Detectable osteolysis on low dose CT (at least 5 mm in size).

    • Stable disease, defined as no signs of progressive disease for three months without anti myeloma treatment (appendix 1).

    • Achieved, partial response or better, during last line of therapy.

    • Signed informed consent.

    • Age ≥ 18 years.

    • Remaining life expectancy ≥ 6 months.

    • ECOG performance status 0-2 (see appendix 2).

    Female patients who:

    • Are postmenopausal for at least 1 year before the screening visit, OR
    • Are surgically sterile,
    OR
    • If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug,
    OR
    • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)

    Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following:

    • Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug,
    OR
    • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject (Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
    E.4Principal exclusion criteria
    • Treatment with denosumab within the last 4 weeks.

    • Known concurrent malignancy (last five years), excluding skin cancer.

    • Known hypersensitivity to Ixazomib.

    • Central nervous system involvement.

    • Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.

    • Pregnant or lactating women.

    • Absolute neutrophil count <1,000/mm3 without growth factor support.

    • Platelet count <75,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before inclusion -Total bilirubin >1.5 x the upper limit of the normal range.

    • Alanine aminotransferase >3 x upper limit of the normal range.

    • Calculated creatinine clearance < 30 mL/min (using the Cockcroft-Gault equation).

    • Total bilirubin > 1.5 x the upper limit of the normal range (ULN).

    • Radiotherapy within 14 days before inclusion.

    • Major surgery within 14 days before inclusion.

    • Evidence of current uncontrolled cardiovascular conditions, including uncontrolledhypertension, uncontrolled cardiac arrhythmias, uncontrolled congestive heart failure,unstable angina, or myocardial infarction within the past 6 months.

    • Systemic treatment with strong CYP3A inducers (rifampin, rifapentine, rifabutin,carbamazepine, phenytoin, phenobarbital) or use of St. John’s wort.

    • Peripheral neuropathy grade 1 with pain or grade 2.

    • Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.

    • Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of Ixazomibzomib including difficulty swallowing.

    • Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment.

    • Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Healing of preexisting osteolytic bone lesions in Multiple Myeloma.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 3 months and 2 years of therapy
    E.5.2Secondary end point(s)
    Increased bone formation during Ixazomib treatment in NaF PET. Increased bone anabolism during Ixazomib treatment. Increased bone formation to bone degradation ratio during Ixazomib treatment. Increased bone formation using bone histomorphometric evaluation. Investigate safety and toxicities during Ixazomib treatment. Depth of cancer response to Ixazomib treatment. Adherence to therapy.
    E.5.2.1Timepoint(s) of evaluation of this end point
    secondary endpoints will be evaluated continuously during the trial
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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
    30 patients will be included in the trial
    All patients will be treated for 24 months
    The trial will end when the last patient has received the last treatment
    An additional follow up of three months is planned
    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 months
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    Three months follow up
    After that none is planned
    Patients will be followed according to standard routine after than time point
    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 Decision2019-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-01-10
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