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    Summary
    EudraCT Number:2012-004884-29
    Sponsor's Protocol Code Number:12-BI-505-02
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-12-06
    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 ConcernedSweden - MPA
    A.2EudraCT number2012-004884-29
    A.3Full title of the trial
    A single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With BI-505, a Human Anti–Intercellular Adhesion Molecule 1 Monoclonal Antibody, In Patients With Smoldering Multiple Myeloma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-label Phase 2 Study in Patients with Asymptomatic Multiple Myeloma
    A.4.1Sponsor's protocol code number12-BI-505-02
    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 SponsorBioInvent International AB
    B.1.3.4CountrySweden
    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 supportBioInvent International AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioInvent International AB
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressSölvegatan 41
    B.5.3.2Town/ cityLund
    B.5.3.3Post codeSE-22370
    B.5.3.4CountrySweden
    B.5.4Telephone number46462868646
    B.5.5Fax number46462110806
    B.5.6E-mailelisabeth.sonesson@bioinvent.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/08/600
    D.3 Description of the IMP
    D.3.1Product nameBI-505
    D.3.2Product code BI-505
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNNot assigned
    D.3.9.3Other descriptive nameBI-505
    D.3.9.4EV Substance CodeSUB31198
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant human monoclonal antibody directed against intercellular adhesion molecule-1 (ICAM-1)
    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
    Smoldering (asymptomatic) multiple myeloma
    E.1.1.1Medical condition in easily understood language
    Multiple myeloma is a cancer of white blood cells responsible for producing antibodies. Abnormal plasma cells accumulate in the bone marrow, interfering with the production of normal blood cells.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 tumor response rate (defined according to the IMWG uniform response criteria)
    E.2.2Secondary objectives of the trial
    To further assess clinical safety of BI-505
    To further assess the pharmacokinetic profile of BI-505
    To further assess the pharmacodynamics of BI-505
    To further assess the immunogenicity profile of BI-505
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of Smoldering multiple myeloma based on the International Myeloma Working Group criteria:
    a. Serum M-protein greater than or equal to 3 g/dl and/or bone marrow plasma cells greater than or equal to 10 percent.
    b. Absence of end-organ damage such as lytic bone lesions, anemia, hypercalcemia or renal failure that can be attributed to a plasma cell proliferative disorder.
    2. Male or female, 18 years or older.
    3. Ability to understand and willingness to sign an informed consent form.
    4. Measurable disease defined by any one of the following:
    a. Serum monoclonal protein ≥1.0 g/dL.
    b. Serum immunoglobulin free light chain > 10 mg/dl and abnormal kappa/lambda ratio.
    5. ECOG Performance status of 0-1.
    6. Adequate hepatic function with aspartate transaminase and alanine transaminase ≤2.5 times the ULN; direct bilirubin ≤1.5 times the ULN.
    7. Adequate renal function with calculated serum creatinine clearance ≥50mL/min.
    8. Females of childbearing potential and males (and respective partners) must use adequate contraception during the study and at least for 12 weeks after discontinuation. Adequate contraception is defined as oral/systemic contraception, intrauterine device, diaphragm in combination with spermicide, or condom for male partner in combination with spermicide, or had her last natural menstruation at least 24 months prior to baseline, or have been surgically sterilized prior to baseline, or have had a hysterectomy prior to baseline.
    9. No concurrent systemic corticosteroid use within four weeks prior to screening.
    E.4Principal exclusion criteria
    1. Patients with a diagnosis of symptomatic multiple myeloma or a clinical suspicion of an ongoing progression into symptomatic multiple myeloma.

    2. Prior treatment having a proven or potential impact on myeloma cell proliferation or survival (including conventional chemotherapies, biological therapies, immunomodulatory drugs, or proteasome inhibitors).

    3. Use of any investigational agent within the last 3 months.

    4. Current active infectious disease or positive serology for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), or Hepatitis B Surface Antigen.

    5. History of allograft or solid organ transplantation.

    6. Prior malignancy within 2 years, excluding smoldering multiple myeloma, adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, prostate cancer Gleason < 6 and PSA < 10 ng/mL, radically excised LCIS/DCIS < 15 mm breast cancer in women > 40 yr, or any malignancy for which subject has undergone potentially curative therapy with no evidence of that disease for three years, or for which the treating physician deems the subject to be at low risk for recurrence.
    7. A history of cerebrovascular disease or atrial fibrillation unless cerebrovascular disease > 2 years ago and adequately treated with statins, antihypertensive and antithrombotic therapy; or atrial fibrillation, well controlled with medication.
    8. Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure > NYHA (New York Heart Association) grade 3, unstable coronary disease or oxygen-dependent COPD.
    9. Clinical findings indicating cardiac or renal AL amyloidosis.
    10. Evidence of significant active infection, requiring intravenous antibiotics, within 14 days before enrollment.
    11. Substance abuse or other concurrent medical conditions that, in the investigator’s opinion, could confound study interpretation or affect the patient’s ability to tolerate or complete the study.
    12. Significant autoimmune disease requiring systemic treatment with steroids or other immunosuppressive drugs during the last 24 months. This includes rheumatoid arthritis, systemic lupus erythematosis, inflammatory bowel disease, psoriasis, multiple sclerosis, hemolytic anemia and glomerulonephritis or other condition that has required such therapy. Mild autoimmune phenomena or inactive disease are not exclusion criteria.
    13. Breast feeding women or women with a positive pregnancy test.
    E.5 End points
    E.5.1Primary end point(s)
    Tumor response rate according to the IMWG criteria (Complete response, Partial response, Minimal response) assessed by measurements of serum M-protein, serum free light chains, and bone marrow plasma cells
    E.5.1.1Timepoint(s) of evaluation of this end point
    At screening, on Days 1, 22, 36, 50, 64, 78, 92, 106, 120, 134 and EOS
    E.5.2Secondary end point(s)
    Clinical safety parameters (Adverse events, clinical laboratory tests, ECG and vital signs)
    Pharmacokinetic parameters (AUC0-168h, CL, Cmax, Ctrough, tmax, t½, Vz)
    Immunogenicity of BI-505 by measuring antibodies against BI-505
    Pharmacodynamic parameters (including ICAM-1 saturation on bone marrow plasma cells)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Adverse events: At screening, on Days 1, 8, 22, 36, 50, 64, 78, 92, 106, 120, 134 and EOS
    clinical laboratory tests: At screening, on Days 1, 22, 50, 92, 134 and EOS
    ECG: At screening and EOS
    vital signs: At all visits, i.e. At screening, on Days 1, 8, 22, 36, 50, 64, 78, 92, 106, 120, 134 and EOS
    Pharmacokinetic parameters: At Day 1 predose and +30min, Day 8 predose and +30 min, +2h and +6h, Days 22, 36, 50, 64, 78, 92, 106, 120, 134 predose and +30min and EOS
    Immunogenicity: At Day 1 predose and EOS
    Pharmacodynamic parameters: At screening, on Days 1, 22, 36, 50, 64, 78, 92, 106, 120, 134 and EOS
    ICAM-1 saturation on bone marrow plasma cells: At screening and on Day 50. In addition a sample will be taken to confirm response as meassured by M-component/free light chain.
    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 No
    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 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 Yes
    E.8.1.7.1Other trial design description
    single arm
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 10
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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)
    None
    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 Decision2013-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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