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    EudraCT Number:2016-001737-27
    Sponsor's Protocol Code Number:54767414AMY3001
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-11-28
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2016-001737-27
    A.3Full title of the trial
    A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis
    A.4.1Sponsor's protocol code number54767414AMY3001
    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 SponsorJanssen-Cilag International N.V.
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International N.V.
    B.5.2Functional name of contact pointClinical Registry group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333
    B.5.4Telephone number+31715242166
    B.5.5Fax number+31715242110
    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/3/13/1153
    D.3 Description of the IMP
    D.3.1Product nameDaratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
    D.3.2Product code JnJ 54767414
    D.3.4Pharmaceutical form 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 INNDARATUMUMAB
    D.3.9.1CAS number 945721-28-8
    D.3.9.2Current sponsor codeJnJ 54767414
    D.3.9.3Other descriptive nameHUMAX-CD38
    D.3.9.4EV Substance CodeSUB175772
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 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
    AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
    E.1.1.1Medical condition in easily understood language
    Amyloidosis refers to a disease in which abnormally folded protein (amyloid) deposits in various organs and tissues in the body.
    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 PT
    E.1.2Classification code 10002022
    E.1.2Term Amyloidosis
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the efficacy of daratumumab plus CyBorD compared with CyBorD
    alone in the treatment of newly diagnosed AL amyloidosis patients.
    E.2.2Secondary objectives of the trial
    To evaluate the clinically observable endpoints for major organ deterioration (MOD-PFS) following treatment with daratumumab in combination with CyBorD compared with CyBorD alone
    To evaluate the following efficacy measures following treatment with daratumumab in combination
    with CyBorD compared with CyBorD alone:
    - Progression-free survival (PFS)
    - Organ response rate (OrRR)
    - Overall survival (OS)
    - Time and duration of response
    To evaluate fatigue, mental functioning, and health-related quality of life following treatment with
    daratumumab in combination with CyBorD compared with CyBorD alone
    To assess the safety and tolerability of daratumumab when administered in combination with
    To assess the pharmacokinetics of daratumumab and the immunogenicity of daratumumab and
    To explore minimal residual disease status in amyloidosis patients as a surrogate for PFS and OS or
    as a biomarker for relapse
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) or older.
    2) Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry and polarizing light microscopy of green bi-refringent material in congo red stained tissue specimens (in an organ other than bone marrow) or characteristic electron microscopy appearance
    Considerations for specific populations where other types of amyloidosis may be encountered:
    - For male subjects 70 years of age or older who have cardiac involvement only, and subjects of African descent (black subjects), mass spectrometry typing of AL amyloid in a tissue biopsy is recommended to rule out other types of
    amyloidosis such as age-related amyloidosis or hereditary amyloidosis (ATTR mutation)
    3) Measurable disease of amyloid light chain amyloidosis as defined by at least ONE of the following:
    -serum monoclonal protein ≥0.5 g/dL by protein electrophoresis (routine serum protein electrophoresis and immunofixation performed at central lab),
    -serum free light chain ≥5.0 mg/dL with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) ≥5mg/ dL.
    4) One or more organs impacted by AL amyloidosis according to consensus guidelines
    5) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
    6)Pre-treatment clinical laboratory values meeting the following criteria during the Screening Phase:
    a. Absolute neutrophil count ≥1.0 ×1000000000 /L;
    b. Hemoglobin level ≥8.0 g/dL (≥5 mmol/L); red blood cell transfusion allowed until 7 days before randomization
    c. Platelet count ≥50 × 1000000000/L; Platelet transfusions are acceptable without restriction during the screening period
    d. Alanine aminotransferase level (ALT) ≤2.5 times the ULN;
    e. Aspartate aminotransferase (AST) ≤2.5 times the ULN
    f. Total bilirubin level ≤1.5 × ULN except for subjects with Gilbert syndrome, in which case direct bilirubin ≤2 × ULN
    g. Estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73m2. Please note the eGFR is measured by using the CKD-epi equation
    7)Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse (if this is the preferred and usual lifestyle of the subject) or to use 2 methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device, hormonal [birth control pills, injections, hormonal patches, vaginal rings or implants] or partner’s vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin 4 weeks prior to dosing and continue for 1 year after discontinuation of cyclophosphamide or 3 months after discontinuation of daratumumab, whichever is longer. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy.
    8)During the study and for 1 year after stopping cyclophosphamide or 3 months after receiving the last dose of daratumumab, whichever is longer, a woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction.
    9)A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control; eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository during and up to 4 months after discontinuation of cyclophosphamide or 3 months after discontinuation of daratumumab, whichever is longer. All men must also not donate sperm during the study and for 4 months after discontinuation of cyclophosphamide or 3 months after discontinuation of daratumumab, whichever is longer.
    10) A woman of childbearing potential must have a negative serum or urine pregnancy test result within 14 days prior to randomization.
    11) Each subject, or legally acceptable representative, must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the
    E.4Principal exclusion criteria
    1.Prior therapy for AL amyloidosis or multiple myeloma including medications that target CD38, with the exception of 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to randomization
    2.Previous or current diagnosis of symptomatic multiple myeloma, including the presence of lytic bone disease, plasmacytomas, ≥60% plasma cells in the bone marrow, or hypercalcemia
    3.Evidence of significant cardiovascular conditions as specified below:
    a.NT-ProBNP >8500 ng/L
    b.New York Heart Association (NYHA) classification IIIB or IV heart failure
    c.Heart failure that in the opinion of the investigator is on the basis of ischemic heart disease (eg prior myocardial infarction with documented history of cardiac enzyme elevation and ECG changes)or uncorrected valvular disease
    and not primarily due to AL amyloid cardiomyopathy
    d.Inpatient admission to a hospital for unstable angina or myocardial infarction within the last 6 months prior to first dose or percutaneous cardiac intervention with recent stent within 6 months or coronary artery bypass grafting within
    6 months
    e.For subjects with congestive heart failure, cardiovascular-related hospitalizations within 4 weeks prior to randomization
    f.Subjects with a history of sustained ventricular tachycardia or aborted ventricular fibrillation or with a history of atrioventricular (AV) nodal or sinoatrial (SA) nodal dysfunction for which a pacemaker/ICD is indicated but not placed (Subjects who do have a pacemaker/ICD are allowed on study)
    g.Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia’s formula (QTcF) >500 msec.Subjects who have a pacemaker may be included regardless of calculated QTc interval
    h.Supine systolic blood pressure <90 mm Hg, or symptomatic orthostatic hypotension, defined as a decrease in systolic blood pressure upon standing of >20 mmHg despite medical management (eg, midodrine, fludrocortisones)in the absence of volume depletion
    4.Planned stem cell transplant during the first 6 cycles of protocol therapy are excluded.Stem cell collection during the first 6 cycles of protocol therapy is permitted
    5.History of malignancy (other than AL amyloidosis)within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin,carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)
    6.Chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) <50% of predicted normal.Note that FEV1 testing is required for subjects suspected of having COPD and subjects must be excluded if FEV1 <50% of predicted normal
    7.Moderate or severe persistent asthma within the past 2 years,or currently has uncontrolled asthma of any classification.(Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study)
    8.Seropositive for human immunodeficiency virus(HIV)
    9.Known to have hepatitis B surface antigen positivity,or known to have a history of hepatitis C
    10.Grade 2 sensory or Grade 1 painful peripheral neuropathy
    11.Known hypersensitivity to bortezomib,boron or mannitol
    12.Concurrent medical condition or disease (eg, active systemic infection)that is likely to interfere with study procedures or results,or that in the opinion of the investigator would constitute a hazard for participating in this study
    13.Any form of non-AL amyloidosis,including wild type or mutated (ATTR)amyloidosis
    14.Known allergies,hypersensitivity,or intolerance to monoclonal antibodies or human proteins,or their excipients (refer to Investigator Brochure),or known sensitivity to mammalian-derived products
    15.Known or suspected of not being able to comply with the study protocol (eg, because of alcoholism,drug dependency,or psychological disorder)or the subject has any condition for which,in the opinion of the investigator, participation would not be in the best interest of the subject (eg,compromise their well-being)or that could prevent,
    limit,or confound the protocol-specified assessments
    16. Woman who is pregnant or breast-feeding or planning to become pregnant while enrolled in this study or within 1 year after discontinuation of cyclophosphamide or 3 months following discontinuation of daratumumab,whichever is longer
    17.Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before Cycle1,Day 1
    18. Major surgery within 2 weeks before Cycle1,Day1,or will not have fully recovered from surgery,or has surgery planned during the time the subject is expected to participate in the study or within 2 weeks after the last dose of study drug administration.Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is overall complete hematologic response rate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During cycles 1 through 6 every 28 days, then Cycle 7+ and during the observation phase Every 8 weeks until disease progression according to MOD-PFS criteria.
    E.5.2Secondary end point(s)
    - Major Organ Deterioration Progression-Free Survival (MOD-PFS). This is a composite endpoint of clinically observable endpoints and will be defined from randomization to any one of the following events, whichever comes first:
    1. Death
    2. Clinical Manifestation of Cardiac Failure: Defined as development of dyspnea at rest (for at least 3 consecutive days) and due solely to amyloidosis cardiac deterioration, or need for cardiac transplant, left ventricular assist device (LVAD), or intra-aortic balloon pump (IABP)
    3. Clinical Manifestation of Renal Failure: Defined as the development of end stage renal disease (need for hemodialysis or renal transplant)
    4. Development of hematologic PD as per consensus guidelines From CHR, any detectable monoclonal protein or abnormal free light chain ratio (light chain ratio must double). Note: the development of a IgG Kappa spike on SPEP/IFE
    will not be considered disease progression for subjects who have received daratumumab, DIRA testing may be indicated.
    From PR, 50% increase in serum M-protein to > 0.5 g/dL or 50% increase in urine M-protein to >200 mg/day (a visible peak must be present) Free light chain increase of 50% to > 100 mg/L
    -Progression-free survival (PFS) is defined as the time from the date of randomization to the date of first documentation of hematologic disease progression, or organ (cardiac, renal, or liver) progression, or death due to any cause, whichever occurs first according to central laboratory results and judged by international consensus guidelines. For those subjects who are still alive and have not yet progressed, the subject’s data will be censored at the last disease assessment.
    - Organ response rate (OrRR) for kidney, heart, liver is defined as the proportion of baseline organ involved subjects who achieve organ response in each corresponding organ.
    -Overall survival (OS) is measured from the date of randomization to the date of the subject’s death. If the subject is alive or the vital status is unknown, then the subject’s data will be censored at the date the subject was last known to be alive.
    -Improvement in fatigue is defined as the change from baseline in the EORTC QLQ-C30 Fatigue scale score, improvement in mental functioning is defined as the change from baseline in the SF-36v2 MCS, and improvement in health-related quality of life is defined as change from baseline in the EORTC QLQ-C30 Global Health Status scale score.
    -Time to next treatment (TNT) defined as the time from the date of randomization to the start date of subsequent AL amyloidosis (non-protocol). Death due to PD prior to subsequent therapy is considered as an event. Otherwise, TNT is censored at the date of death or the last date known to be alive.
    - Hematologic VGPR or better rate is defined as the proportion of subjects who achieve hematologic CR or VGPR.
    -Time to complete hematologic response (or VGPR or better) is defined as the time between the date of randomization and the first efficacy evaluation at which the subject has met all criteria for hematologic CR (or VGPR or better). For subjects without a hematologic CR (or VGPR or better), data will be censored either at the date of progressive disease or, in the absence of progressive disease, at the last disease assessment.
    -Duration of complete hematologic response (or VGPR or better) is defined as the time between the date of initial documentation of CHR (or VGPR or better) to the date of first documented evidence of hematologic progressive disease. For subjects who have not progressed, data will be censored at the last disease assessment.
    -Time to organ response is defined as the time between the date of randomization and the first efficacy evaluation at which the subject has each corresponding organ response. For subjects without organ response, data will be censored either at the date of the corresponding organ progressive disease or, in the absence of organ progressive disease, at the last disease assessment.
    -Duration of organ response is defined as the time between the date of initial documentation of each corresponding organ response to the date of first documented evidence of the corresponding organ progressive disease. For subjects who have not had organ progression, data will be censored at the last disease assessment
    E.5.2.1Timepoint(s) of evaluation of this end point
    During cycles 1 through 6 every 28 days, then Cycle 7+ and during the observation phase Every 8 weeks until disease progression according to MOD-PFS criteria.

    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 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. 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    Active monitoring
    E.8.2.4Number of treatment arms in the trial2
    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 EEA71
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Korea, Republic of
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    The end of study is defined to be 5 years after the last subject is randomized. Please see Protocol Section 17.9.1.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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: 56
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 314
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 370
    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)
    Subjects will be instructed that study drug will not be available to them after they have completed/discontinued treatment and that they should return to their primary physician to determine standard ofcare (Prot Sect 9.1.5).Patients receiving daratumumab and who continue to benefit from the study treatment when study is over will have the option to continue on daratumumab treatment for a max of 2 year from the start of the study.Sponsor plans to provide study medication to these patients
    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 Decision2018-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-22
    P. End of Trial
    P.End of Trial StatusOngoing
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