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    Summary
    EudraCT Number:2005-003264-38
    Sponsor's Protocol Code Number:ML18508
    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:2005-10-05
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-003264-38
    A.3Full title of the trial
    COMPARE: Comparison Ibandronate - Zoledronate regarding nephrotoxicity in patients with multiple myeloma
    A.3.2Name or abbreviated title of the trial where available
    COMPARE
    A.4.1Sponsor's protocol code numberML18508
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRoche Pharma AG
    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 support
    B.4.2Country
    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
    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 Bondronat 6mg/6ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
    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.3.1Product nameBondronat 6 mg/6 ml
    D.3.2Product code Ro 200-5450
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNIbandronic acid
    D.3.9.3Other descriptive nameIbandronate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6 mg/ to 6 ml
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 RoleComparator
    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 Zometa 4 mg/5 mg concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited, Wimble Hurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom
    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.3.1Product nameZometa 4 mg/5 ml
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNZoledronic acid
    D.3.9.3Other descriptive nameZoledronate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4 mg/ to 5 ml
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Patients with confirmed multiple myeloma stage II-III according to Salmon and Durie, where treatment with bisphosphonate is indicated.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of renal safety under treatment with 6 mg Ibandronate or 4 mg Zoledronate i.v. over 15 min. The only primary target variable is the ratio of patients with deterioration of the renal function. Considered as a relevant deterioration is a decrease of creatinine clearance (calculated according to Cockcroft-Gault) of 30 % or a decline to ≤ 30ml/min.
    E.2.2Secondary objectives of the trial
    1. Time until the first skeletal event (SRE, skeletal related events).
    2. Number of skeletal events in the respective treatment group.
    3. Number of patients with at least one skeletal event.
    4. Number of osteonecrosis of the jaw.
    5. Frequency of dose reduction under Zoledronate as absolute value.
    6. Percentage deterioration baseline at 44 week value and baseline at 92 week value of N-acetyl-β-D-glucosaminidase, α1-microglobulin and γ-glutamyl-transferase.
    7. Percentage of patients with an increase of the serum creatinine value of more than 0.5 mg/dl (in patients with an inital serum creatinine level < 1.4 mg/dl) or 1.0 mg/dl (in patients with an initial serum creatinine level ≥1.4 mg/dl) versus baseline after 44 or 92 weeks (measured in the central laboratory).
    8. Evaluation of the percentage drop in creatinine clearance baseline at 44 week value and baseline at 92 week value.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Confirmed multiple myeloma stage II-III according to Salmon and Durie, where treatment with bisphosphonate is indicated.
    2. Willingness to give written informed consent, written consent for data protection (legal requirement in Germany: datenschutzrechtliche Einwilligung) and willingness to participate and to comply with the study.
    3. Age ≥ 18 years.
    E.4Principal exclusion criteria
    1. Previous treatment with Ibandronate or Zoledronate within the last 12 months; previous treatment with other bisphosphonates is permissible (in case of intravenous bisphosphonate treatment: period between last infusion and screening ≥ 3 weeks).
    2. Renal insufficiency with a serum creatinine > 3.0 mg/dl or > 265 µmol/l or a creatinine clearance < 30 ml/min (Cockcroft-Gault formula) based on the values determined by the central laboratory.
    3. Hypersensitivity to Ibandronate, Zoledronate or other bisphosphonates.
    4. The presence of secondary malignant neoplasms, except for basalioma or cervical carcinoma in situ.
    5. Serious concomitant organic disease.
    6. Difficult to control insulin-dependent diabetes mellitus.
    7. Glaucoma or phaeochromocytoma.
    8. Acute myocardial infarction within the last six months.
    9. Patients proven to have HIV infection.
    10. As the following medication(s) can have interactive effects and may interfere with the patient's ability to meet the study requirements, they cannot be administered during the clinical study: Aminoglycosides.
    11. Chemotherapy with Cisplatin or Methotrexate at study start.
    12. Osteonecrosis of the jaw at study start.
    13. Planned invasive dental intervention (e.g. extraction).
    14. Life expectancy of <= 12 months.
    15. Women lactating, pregnant or of childbearing potential not using a highly effective contraceptive method (allowed methods of birth control, i.e. with a failure rate of less than 1 % per year, are implants, injectables, combined oral contraceptives, IUDs (only hormonspirals), secual absti-nence or vasectomized partner). Women of childbearing potential must have a negative pregnancy test (serum, β HCG) at visit 1.
    16. Treatment with a medicinal product that has not yet been approved (with the exception of Thalidomide) during the study or within the last 30 days or 7 half lives, whichever is the longer.
    17. Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
    18. Patients who participates currently in another clinical trial or patients who participated in another clinical trial during the study or within the last 30 days or 7 half lives, whichever is the longer.
    19. Patients who have participated in this study before.
    20. Patients who are underage or patients who are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and § 41 Abs. 2 und Abs. 3 AMG).
    21. Patients who possibly are dependent on the sponsor or investigator.
    22. Patients who are scheduled for allogenic stem cell transplantation.
    E.5 End points
    E.5.1Primary end point(s)
    The renal safety will be evaluated by the number of patients with increase in serum creatinine value by more than 0.5 mg/dl (in patients with an initial serum creatinine level of < 1.4 mg/dl) or 1.0 mg/dl (in patients with an initial serum creatinine level ≥ 1.4 mg/dl).
    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 Yes
    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) Yes
    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 concerned60
    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 Information not present in EudraCT
    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
    End of the study ist defined as last patient last out.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state94
    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)
    Upon completion of the study, patients will be transferred to the routine therapy. The investigator is responsible for the decision about the subsequent treatment (e.g. subsequent treatment with Zoledonic acid (approved for this indication) or with another approved bisphosphonate or treatment within an expanded access program with Ibandronic acid upon its approval (at most for a further year)).
    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 Decision2005-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-04-03
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    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
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