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    Summary
    EudraCT Number:2011-004651-40
    Sponsor's Protocol Code Number:SNOXA12C301
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-09
    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 ConcernedAustria - BASG
    A.2EudraCT number2011-004651-40
    A.3Full title of the trial
    A multi-center, open label, uncontrolled, Phase IIa clinical trial evaluating the safety and efficacy of NOX-A12 in combination with a background therapy of bortezomib and dexamethasone (VD) in previously treated patients with multiple myeloma (MM)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial of NOX-A12 in patients with mutiple myeloma who have previously been treated and who will be receiving bortezomib and dexamethasone treatment.
    A.3.2Name or abbreviated title of the trial where available
    NOX-A12 in combination with bortezomib and dexamethasone in Multiple Myeloma.
    A.4.1Sponsor's protocol code numberSNOXA12C301
    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 SponsorNOXXON 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 supportNOXXON Pharma AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAMS Advanced Medical Services
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address1 Lyric Square
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW6 0NB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number440203751 1350
    B.5.5Fax number440203751 1351
    B.5.6E-mailoperations@ams-europe.com
    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.3.2Product code NOX-A12
    D.3.4Pharmaceutical form Solution for injection
    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 INNSpieglelmer A12
    D.3.9.2Current sponsor codeNOX-A12
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number14.66
    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
    Relapsed multiple myeloma
    E.1.1.1Medical condition in easily understood language
    Multiple Myeloma which has been previously treated and disease has returned
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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
    To assess the safety and tolerability of NOX-A12 alone (pilot group only) and in combination with VD

    To determine the overall response rate according to IMWG uniform response criteria (ORR = best response at least partial response(PR))
    E.2.2Secondary objectives of the trial
    • To determine the effect of NOX A12 alone and in combination with VD on the mobilization of peripheral blood CD34+ cells, plasma cells and myeloma cells
    • To determine additional response criteria adopted from the EBMT criteria such as minor response (MR), immunophenotypic CR and molecular CR after treatment with NOX-A12 combined with VD
    • To determine time to event endpoints such as progression free survival (PFS), time to progression (TTP) and duration of response (DOR) after treatment with NOX A12 combined with VD
    • To determine the plasma concentration of SDF-1 after treatment with NOX-A12 alone (pilot group only) and in combination with VD
    • To determine the pharmacokinetics of NOX A12 alone (pilot group only) and in combination with VD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female, aged ≥ 18 years
    2.Diagnosis of relapsed multiple myeloma for which bortezomib/dexamethasone would be given as standard of care.
    3.Bortezomib-naïve or bortezomib-sensitive patient (i.e. best response of PR or better, sustained for at least 6 months), who did not receive bortezomib during the last line of therapy for MM prior to this study.
    4.Progressive disease according to International Myeloma Working Group criteria.
    5.Pre-study WHO Performance Status ≤ 2 and modified CIRS score of less than 7
    6.Signed and dated, written informed consent.
    7.Men and women of reproductive potential must agree to follow accepted contraception methods during treatment and for 3 months after completion of treatment.
    8.Acceptable liver function: Bilirubin ≤ 1.5 x upper limit of normal (ULN) (according to the Summary of Product Characteristics of Velcade).
    9.Acceptable hematology and hemostasis status: Platelet count ≥ 75 x 109/L, ANC > 0.75x109/L.
    10.Acceptable renal function: Serum creatinine ≤1.5 ULN and/or calculated creatinine clearance ≥ 50 mL/min (calculated according to Cockroft & Gault formula).
    11.No clinically significant abnormalities of liver volume, liver hemodynamics or elasticity, measured by abdominal ultrasound.
    E.4Principal exclusion criteria
    1.The patient has a history of, or is clinically suspicious for, cancer-related Central Nervous System disease.
    2.Prior allogeneic stem cell transplant (alloSCT) or patients who are considered to be candidates for alloSCT as assessed by their treating physician.
    3.Patient has a history of other active malignancies within 3 years prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma of the skin; in situ carcinoma of the bladder; previous malignancy confined and surgically resected with curative intent.
    4.The patient exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection (viral, bacterial, or fungal); diagnosis of fever and neutropenia within 1 week prior to study drug administration.
    5.Female patient is pregnant or breast-feeding.
    6.Known infection with HIV, active Hepatitis B or Hepatitis C.
    7.The patient has a history of prior toxicity from bortezomib or dexamethasone that resulted in permanent discontinuation of respective treatments.
    8.Clinical evidence of a current significant (grade 2 or higher) or progressive neuropathy.
    9.Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to study drug administration.
    10.Uncontrolled hypertension (defined as systolic blood pressure [BP] > 160 mm Hg or diastolic BP > 100 mm Hg).
    11.Myocardial infarction or unstable angina within the past 6 months prior to study drug administration. Heart failure of New York Heart Association functional Class III or IV prior to study drug administration.
    12.Evidence of bleeding diathesis (greater than normal risk of bleeding) or coagulopathy (in the absence of therapeutic anticoagulation).
    13.Systemic illnesses or other severe concurrent disease or alcoholism, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and efficacy of the investigational treatments.
    14.Known or suspected of not being able to comply with the trial protocol.
    15.Having been previously enrolled in this clinical trial.
    E.5 End points
    E.5.1Primary end point(s)
    Safety
    The safety evaluation will be based on the following assessments:
    • adverse events
    • vital signs
    • 12 lead ECGs
    • laboratory parameters (CBC, platelets, differential WBC count, serum chemistry, coagulation parameters, urinalysis)
    • immunogenicity
    Efficacy
    Assessment of the overall tumor response - as measured by serum free light chain, serum and urinary M-protein, clonal plasma cell counts in blood and bone marrow, plasmacytoma size measurements and prescence of bone lesions.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety - throughout the treatment period and for 30 days post last dose.

    Efficacy - at the end of cycle 4 and cycle 8.
    E.5.2Secondary end point(s)
    • mobilisation of CD34+ cells, plasma cells and myeloma cells
    • immunophenotyping of CD34+ cells, plasma cells and myeloma cells
    • survival free of disease
    • pharmacokinetic analysis of SDF-1 in plasma
    • pharmacokinetic analysis of NOX-A12 in plasma
    E.5.2.1Timepoint(s) of evaluation of this end point
    Characteristation of blood circulating cells - Pilot group - Day1,2 and 4 post dose. All patients - Day 1 and 2 Cycle 1 and 4.

    SDF-1 and NOX-A12 pharmacokinetic analysis - pilot group Day1,2 and 4 post dose. With VD - Day1,4,8,11 and 21 of Cycle 1 and 4.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    End of trial will be the date of the Last Patient Last Visit in the follow up period for the expansion part of the trial.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 28
    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)
    Following completion of upto 8 cycles of NOX-A12 treatment prior to the receipt of VD, patients will continue under normal local tratment practices. Patients who have experienced a response will be followed for the duration of their response, but may recieve any care - including transplantation - which may be available to them locally.
    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 Decision2012-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-30
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