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    Summary
    EudraCT Number:2016-002771-10
    Sponsor's Protocol Code Number:MP0250-CP201
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-11-29
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-002771-10
    A.3Full title of the trial
    A Phase II open-label, single-arm, multicenter trial of MP0250 plus bortezomib+dexamethasone in patients with refractory and relapsed multiple myeloma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II open-label (non-blinded), single-arm (same treatment for all participants) multicenter trial of MP0250 plus bortezomib+dexamethasone in patients with multiple myeloma whose disease did not respond to/has recurred after standard treatments
    A.3.2Name or abbreviated title of the trial where available
    A single arm study of MP0250+bortezomib+Dexamethasone in patients with Refractory and relapsed MM
    A.4.1Sponsor's protocol code numberMP0250-CP201
    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 SponsorMolecular Partners AG
    B.1.3.4CountrySwitzerland
    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 supportMolecular Partners AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMolecular Partners AG
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressWagistrasse 14
    B.5.3.2Town/ citySchlieren
    B.5.3.3Post code8952
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMP0250.CP201@molecularpartners.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.3.1Product nameMP0250
    D.3.2Product code MP0250
    D.3.4Pharmaceutical form Concentrate and solvent for 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 INNMP0250
    D.3.9.2Current sponsor codeMP0250
    D.3.9.3Other descriptive nameMP0250 (DS)
    D.3.9.4EV Substance CodeSUB166230
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 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 Yes
    D.3.11.13.1Other medicinal product typeMP0250 is a novel biological therapeutic agent
    D.IMP: 2
    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 VELCADE
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG INTERNATIONAL NV
    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 nameVELCADE
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBORTEZOMIB
    D.3.9.1CAS number 179324-69-7
    D.3.9.4EV Substance CodeSUB20020
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    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.IMP: 3
    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 Dexamethasone
    D.2.1.1.2Name of the Marketing Authorisation holdermibe GmbH Arzneimittel
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameDexamethason 4 mg JENAPHARM®
    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 INNDEXAMETHASONE
    D.3.9.1CAS number 50-02-2
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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.IMP: 4
    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.3.1Product nameMP0250
    D.3.2Product code MP0250
    D.3.4Pharmaceutical form Concentrate and solvent for 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 INNMP0250
    D.3.9.2Current sponsor codeMP0250
    D.3.9.3Other descriptive nameMP0250 (DS)
    D.3.9.4EV Substance CodeSUB166230
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 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 Yes
    D.3.11.13.1Other medicinal product typeMP0250 is a novel biological therapeutic agent
    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 (MM) is a relatively rare (114 000 new cases worldwide in 2012, i.e. 0.8% of total cancer cases [Cancer Research UK Incidence Statistics 2016]) blood cancer for which there is no cure. Treatment options rather mitigate symptoms and defer end-stage disease. MM cells have a tendency to clonally evolve which results in development of drug resistance, and patients eventually relapse.
    E.1.1.1Medical condition in easily understood language
    Multiple myeloma is a blood cancer characterized by expansive growth of plasma cells which leads to anemia, bleedings, severe infections, kidney-injuries and other complications and finally to death
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary
    Part 1 (Part 1 is completed)
    - Estimate the efficacy of MP0250 plus bortezomib+dexamethasone,
    based on overall response rate (ORR), in patients with MM who have
    received ≥2 lines of therapy, including bortezomib and an
    Immunomodulatory Drug (IMiD), and have shown no response to, or
    have progressed on the most recent treatment, or within 60 days of the
    most recent therapy.
    Part 2
    - To assess the preliminary efficacy of MP0250 in combination with
    bortezomib plus dexamethasone in patients with refractory MM who
    have received ≥2 lines of therapy including a proteasome inhibitor
    (bortezomib, carfilzomib or both) and an IMiD (thalidomide,
    lenalidomide and/or pomalidomide) either alone or in combination and
    whose last line of therapy is either a bortezomib-or carfilzomib-based
    regimen.
    E.2.2Secondary objectives of the trial
    -Determine the safety profile of MP0250 plus bortezomib+dexamethasone

    -Characterize the immunogenicity of MP0250

    -Estimate the efficacy of MP0250 in combination with bortezomib+dexamethasone in terms of progression free survival (PFS) and duration of response (DOR)

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the
    following criteria apply:
    Type of Participant and Disease Characteristics
    1. Patients with MM who have received:
    Part 1 (Completed)
    - ≥2 lines of therapy (including bortezomib and an IMiD), and
    - Have shown no response (i.e. stable disease) to, or
    - Have progressed in the most recent treatment, or
    - Have progressed within 60 days of the most recent therapy.
    Part 2
    - ≥2 lines of prior therapy that included a proteasome inhibitor
    (bortezomib, carfilzomib or both) and an IMiD (thalidomide,
    lenalidomide and/or pomalidomide) either alone or in combination and,
    - a response no better than SD lasting at least 4 months on a
    bortezomib- or carfilzomib-based, regimen as last line of therapy or,
    - progression on treatment or within 60 days of stopping a bortezomibor
    carfilzomib-based regimen as last line of therapy.
    Note: For transplant-eligible patients enrolled to Part 1 or Part 2,
    induction plus conditioning chemotherapy/ASCT +/- maintenance
    therapy constitute one regimen.
    2. Presence of a measurable disease with at least one of the following
    criteria:
    - Serum M protein ≥0.5 g/dL, or
    - Urine M protein ≥200 mg/24 h, or
    - Involved serum free light chain (FLC) levels >100 mg/L and abnormal
    kappa/lambda (κ/λ) ratio in patients without detectable serum or urine
    M protein, or
    - For patients with immunoglobulin A (IgA) myeloma whose disease can
    only be reliably measured by quantitative immunoglobulin measurement, a serum IgA level ≥0.5g/dL.
    3. Eastern Cooperative Oncology Group (ECOG) performance status (0 to 1)
    4. Life expectancy >3 months
    5. Adequate hepatic function at Screening, with aspartate
    aminotransferase (AST) and alanine aminotransferase (ALT) <3x ULN
    and total bilirubin <2 x upper limit of normal (ULN). For patients with
    Gilbert's syndrome (Gilbert-Meulengracht syndrome), higher bilirubin of
    5 x ULN is acceptable
    6. Absolute neutrophil count (ANC) ≥1000/mm3 at Screening. Screening
    ANC must be independent of growth factor support for ≥1 week
    7. Hemoglobin ≥8.0 g/dL at Screening. Use of erythropoietic stimulating
    factors and red blood cell (RBC) transfusions per institutional guidelines
    is allowed, however most recent RBC transfusion must not have been
    done within 7 days prior to obtaining screening hemoglobin
    8. Platelet count ≥50 000/mm3 at Screening. Patients must not have
    received platelet transfusions for at least 1 week prior to obtaining the
    screening platelet count
    9. Measured or calculated creatinine clearance (CrCl) of ≥ 45 mL/min at
    Screening based on the Cockcroft and Gault formula:
    (140 - Age) x Mass (kg) / (72 x Creatinine mg/dL); multiply result by
    0.85 if female
    10. Serum albumin concentration ≥ 25 g/L Note: Patients with lower
    levels of serum albumin at baseline may receive albumin
    supplementation to comply with this criterion.
    Sex
    11. Males and females ≥18 years of age
    NOTE: The reliability of sexual abstinence for male and/or female enrollment eligibility needs to be evaluated in relation to the duration of
    the clinical study and the preferred and usual lifestyle of the participant.
    Periodic abstinence (for example, calendar, ovulation, symptothermal, or
    postovulation methods) and withdrawal are not acceptable methods of
    contraception.
    12. Male Participants: A male participant must agree to use a highly
    effective contraception from the Screening visit, during the treatment
    period and for at least 3 months after the last dose of study treatment
    and refrain from donating sperm during this period.
    13. Female Participants: A female participant is eligible to participate if
    she is not pregnant, not breastfeeding, and at least one of the following
    conditions applies:
    a. Not a woman of childbearing potential (WOCBP)
    OR
    b. A WOCBP who agrees to follow the contraceptive guidance from the
    Screening visit, during the treatment period and for at least 3 months
    after the last dose of study treatment
    Informed Consent
    14. Capable of giving signed informed consent which includes
    compliance with the requirements and restrictions listed in the patient
    information sheet (PIS)/informed consent form (ICF) and in this
    protocol.
    E.4Principal exclusion criteria
    Patients are excluded from the study if any of the following criteria
    apply:
    Medical Conditions
    1. Patients with the following diseases:
    - Monoclonal gammopathy of undetermined significance (MGUS) of nonimmunoglobulin (Ig)M and IgM subtypes
    - Light chain MGUS
    - Solitary plasmacytoma (alone or with minimal marrow involvement)
    - Systemic Ig light chain amyloidosis
    - Waldenstrom's Macroglobulinemia
    - Myelodysplastic syndrome
    - Plasma cell leukemia defined as a plasma cell count >2000/mm3
    - Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein,
    and skin changes (POEMS) syndrome
    2. Peripheral neuropathy Grade 2 or higher at Screening or patients with
    a history of Grade 3/4 neuropathy or Grade 2 with pain
    3. Prior or concurrent malignancy, except for:
    - Adequately treated basal cell or squamous cell skin cancer, carcinoma
    in-situ of the cervix or breast or very low and low risk prostate cancer in
    active surveillance
    - Or any other cancer from which the patient has been disease-free for
    >5 years
    4. Active congestive heart failure (New York Heart Association [NYHA]
    Class III to IV), symptomatic cardiac ischemia, or conduction
    abnormalities uncontrolled by conventional intervention. Myocardial
    infarction within 6 months prior to screening
    5. Uncontrolled, hypertension (defined as systolic blood pressure (SBP)
    >150 mm Hg, diastolic blood pressure (DBP) >100 mm Hg despite
    antihypertensive medication)
    6. Stroke, or transient ischemic attack within 6 months of Screening,
    clinically significant bleeding and vascular disease
    7. Abdominal fistula, gastrointestinal perforation, or intra-abdominal
    abscess within the past 6 months
    8. Significant concurrent, uncontrolled medical condition including, but not limited to, severe wound healing complication, renal (except related
    to MM), hepatic, hematological except MM, gastrointestinal, endocrine,
    pulmonary, neurological, cerebral or psychiatric disease
    9. Acute active infection requiring systemic antibiotics, antiviral (except
    antiviral therapy directed at hepatitis B) or antifungal agents within 14
    days prior to screening
    10. Clinical signs of or documented leptomeningeal or cerebral
    involvement of MM
    Prior/Concomitant Therapy
    11. Treatment with ixazomib as last line of therapy in Part 2
    12. Therapy with approved or investigational anticancer therapeutics
    within 21 days (or in the case of nitrosureas, within 6 weeks) prior to
    treatment (except anti-myeloma treatment with a carfilzomib- or
    bortezomib-based regimen in Part 2) Note: Patients must have
    recovered from pre-existing, treatment-related adverse events to Grade
    1 or lower
    13. Autologous stem cell transplantation (ASCT) within 12 weeks before
    the date of enrollment
    14. Prior allogeneic stem cell transplantation with active graft-versus-host-disease
    15. Major surgery within 21 days prior to Screening
    16. Immunotherapy within 21 days prior to Screening
    17. Newly initiated therapy with bisphosphonate or RANKL (within two
    months prior to Screening). Patients on stable regimen with
    bisphosphonate or receptor activator of nuclear kappa-B ligand
    (RANKL)-inhibitor therapy over 2 months can continue these treatments at the same dose. No new therapy with bisphosphonate/RANKL inhibitor is allowed during the study
    18. Radiation therapy within 2 months of Cycle 1, Day 1 is not permitted.Except for local low-dose, palliative radiation to bone lesions for pain control.
    Prior/Concurrent Clinical Study Experience
    19. Patients who have received treatment with any non-marketed
    product within 21 days prior to treatment start
    20. Current participation in any other interventional clinical study
    21. Patients known or suspected of not being able to comply with a
    study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)

    Diagnostic Assessments
    22. Known infection with human immunodeficiency virus or serologic
    status reflecting active hepatitis B or hepatitis C virus infection as
    follows:
    Eligible:
    HIV: Antibody (-)
    HBV: HBsAg (-) and anti-HBc (-): anti-HBs (-)/anti-HBc (+); Responding
    to approved anti-viral therapy with documented reductions in HBV viral
    titers.
    HCV: Antibody (-) or Antibody (+); HCV RNA "not detected" (<15
    IU/mL); monthly monitoring of HCV RNA recommended
    Not Eligible:
    HIV: Antibody (+)
    HBV: HBsAg (+) and/or anti-HBs (-)/anti-HBc (+); Not receiving or not
    responding to anti-viral therapy.
    HCV: Antibody (+); HCV RNA detected
    Other Exclusions
    23. Patients with contraindication to dexamethasone or bortezomib
    according to the applicable local product label
    24. Known hypersensitivity to components of the investigational
    product, for example, histidine buffer or the Tween diluent
    E.5 End points
    E.5.1Primary end point(s)
    Part 1
    - ORR defined as the proportion of patients achieving a complete response (CR), very good partial response (VGPR), or partial response (PR) during treatment with MP0250 plus bortezomib+dexamethasone determined by the Investigator
    (Response subcategories: as defined by the International Myeloma Working Group [IMWG])
    Part 2
    - The primary efficacy endpoint is ORR defined as the proportion of
    patients achieving a complete response (CR), very good partial response
    (VGPR), or partial response (PR) during treatment with MP0250 in
    combination with bortezomib+dexamethasone as determined by the
    Investigator (Response subcategories: as defined by the International
    Myeloma Working Group [IMWG])
    E.5.1.1Timepoint(s) of evaluation of this end point
    evaluations - on day 1 of each treatment cycle and after 8th cycle of treatment (week 24)
    E.5.2Secondary end point(s)
    Type, frequency and severity of adverse events (AEs) based on Common
    Terminology Criteria for Adverse Events (CTCAE) version 4.03; changes
    from baseline in selected laboratory analytes, vital signs and
    electrocardiogram (ECG) findings
    Incidence, titer and time-course of anti-drug antibodies (ADAs)
    PFS (time from first study treatment until progression or death from
    myeloma with deaths from other causes censored) and DOR (duration
    from first observation of PR or better until disease progression or death
    from myeloma with deaths from other causes censored)
    E.5.2.1Timepoint(s) of evaluation of this end point
    evaluations - on day 1 of each treatment cycle and after 8th cycle of treatment (week 24)
    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 Yes
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    EoT Visit will occur between 28 and 35 days after the last study treatment. Patients who discontinue study treatment for reasons other than progression will continue to undergo every 28-day response assessments until they progress, withdraw consent or initiate new antimyeloma therapy. The EoS will occur when the last patient enrolled in Part 2 has completed 8 cycles or discontinued study treatment. Patients will be FU for OS until death, loss to FU or for 2 years after the last dose of MP0250
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 27
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 54
    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)
    Patients who are continuing to derive clinical benefit after the End of Study date may continue study treatment at the discretion of the Investigator. In this case, data from the Day 1 visit of their next cycle will be documented as the EoT Visit for analysis of efficacy and safety endpoints.
    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 Decision2017-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-27
    P. End of Trial
    P.End of Trial StatusOngoing
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