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    Summary
    EudraCT Number:2018-001545-13
    Sponsor's Protocol Code Number:54767414MMY3019
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-09-03
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-001545-13
    A.3Full title of the trial
    A Phase 3 Study Comparing Daratumumab, VELCADE (bortezomib), Lenalidomide, and Dexamethasone (D-VRd) with VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects with Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to Compare Daratumumab, VELCADE (bortezomib), Lenalidomide, and Dexamethasone (D-VRd) with VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects with Untreated Bone Marrow Cancer and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy
    A.4.1Sponsor's protocol code number54767414MMY3019
    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.1.3.4CountryBelgium
    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.5.3.4CountryNetherlands
    B.5.4Telephone number+31715242166
    B.5.5Fax number+31715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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/3/13/1153
    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.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 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
    Multiple Myeloma
    E.1.1.1Medical condition in easily understood language
    Bone marrow cancer
    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 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
    The primary objective is to determine if the addition of daratumumab to VRd will improve overall minimal residual disease (MRD) negativity rate compared with VRd alone.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    ● To determine if the addition of daratumumab to VRd will improve clinical outcome as measured by:
    - Progression-free survival (PFS)
    - MRD negativity rate at 1 year
    - Durability of MRD negativity
    - Overall response rate (ORR) of very good partial response (VGPR) or better, and rate of complete response (CR) or better
    - Time to response
    - Duration of response
    - Time to next treatment
    - Progression-free survival on the next line of therapy (PFS2; defined as time from randomization to progression on the next line of therapy or death, whichever comes first)
    - Overall survival (OS)
    ● To evaluate patient-reported outcomes (PROs) and medical resource utilization
    ● To evaluate the pharmacokinetics (PK) of daratumumab
    ● To determine the immunogenicity of daratumumab and recombinant human hyaluronidase PH20 (rHuPH20)
    ● To assess the safety profile of daratumumab + VRd (D-VRd)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each potential subject must satisfy all of the following criteria to be enrolled in the study:
    1.Newly diagnosed and not considered candidate for high-dose chemotherapy with stem cell transplantation due to:
    ●Being age ≥65 years,or
    ●age 18-65 years with presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with SCT or who refuse high-dose chemotherapy with SCT as initial treatment
    2.Diagnosis of multiple myeloma as documented per International Myeloma Working Group Criteria:Monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy proven plasmacytoma and documented multiple myeloma satisfying at least one of the calcium,renal,anemia,bone(CRAB)criteria or biomarkers of malignancy criteria:
    CRAB criteria:
    1.Hypercalcemia:serum calcium >0.25 mmol/L (>1 mg/dL) higher than upper limit of normal (ULN) or >2.75 mmol/L (>11 mg/dL)
    2.Renal insufficiency:creatinine clearance <40mL/min or serum creatinine >177 μmol/L (>2 mg/dL)
    3.Anemia:hemoglobin >2g/dL below the lower limit of normal or hemoglobin <10g/dL
    4.Bone lesions:one or more osteolytic lesions on skeletal radiography,computed tomography (CT),or positron emission tomography (PET)-CT
    Biomarkers of Malignancy:
    a.Clonal bone marrow plasma cell percentage ≥60%
    b.Involved: uninvolved serum free light chain (FLC)ratio≥100
    c. >1 focal lesion on magnetic resonance imaging (MRI) studies
    3.Must have measurable disease,as assessed by central laboratory,defined by any of the following:
    - IgG,IgA,IgM,IgD,or IgE multiple myeloma:Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours;or
    - Light chain multiple myeloma without measurable disease in serum or urine:Serum Ig FLC ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio
    4.Eastern cooperative oncology group(ECOG) performance status score of 0,1 or2
    5.Clinical laboratory values meeting the following criteria during the Screening Phase:
    a.hemoglobin 7.5g/dL (≥5 mmol/L) (without prior red blood cell [RBC] transfusion within 7days before the laboratory test;recombinant human erythropoietin use is permitted)
    b.absolute neutrophil count (ANC) 1.0 x 10^9/L (granulocyte colony stimulating factor [G-CSF] use is permitted)
    c.platelet count 70 x 10^9/L for subjects in whom <50% of bone marrow nucleated cells are plasma cells;otherwise platelet count >50 × 10^9/L (transfusions are not permitted within 7days)
    d.aspartate aminotransferase (AST) ≤2.5xULN
    e.alanine aminotransferase (ALT) ≤2.5xULN
    f.total bilirubin ≤1.5xULN,except in subjects with congenital bilirubinemia,such as Gilbert syndrome (direct bilirubin ≤2.0 x ULN)
    g.Creatinine clearance (CrCl) ≥30 mL/min.Creatinine clearance can be calculated using the Cockcroft-Gault formula provided in Appendix 8;or for subjects with over- or underweight, CrCl may be measured from a 24-hours urine collection using the formula provided in Appendix 8
    h.corrected serum calcium ≤13.5 mg/dL (≤3.4 mM/L);or free ionized calcium ≤6.5 mg/dL (≤1.6 mM/L)
    6.Female subjects of reproductive childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously during the Treatment Period,during any dose interruptions,and for 3months after the last dose of any component of the treatment regimen.Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug.This birth control method must include 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 4weeks prior to dosing.Reliable contraception is indicated even where there has been a history of infertility,unless due to hysterectomy or bilateral oophorectomy
    7.A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at Screening,first within 10to14 days prior to dosing and the second within 24hours prior to dosing.For requirements during the Treatment Phase
    8.A woman must agree not to donate eggs (ova, oocytes)for the purposes of assisted reproduction during the study and for a period of 3months after receiving the last dose of any component of the treatment regimen
    9.Male subjects of reproductive potential who are sexually active with females of reproductive potential must always use a latex or synthetic condom during the study and for 3months after discontinuing study treatment (even after a successful vasectomy)
    10.Male subjects of reproductive potential must not donate sperm during the study or for 3months after the last dose of study treatment
    Please refer to Protocol for completed list of inclusion criteria
    E.4Principal exclusion criteria
    Any potential subject who meets any of the following criteria will be excluded from participating in the study:
    1. Frailty index of ≥2 according to Myeloma Geriatric Assessment score.
    2. Prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed 40 mg of dexamethasone, or equivalent per day for a maximum of 4 days, total of 160 mg dexamethasone or equivalent).
    3. Prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of date of randomization (exceptions are adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other noninvasive 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).
    4. Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.
    5. Radiation therapy within 14 days of randomization.
    6. Plasmapheresis within 28 days of randomization.
    7. Clinical signs of meningeal involvement of multiple myeloma.
    8. Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted. (FEV1 testing is required for subjects suspected of having COPD).
    9. Moderate or severe persistent asthma within the past 2 years, uncontrolled asthma of any classification. (Subjects who have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study).
    10. Has any of the following:
    a. Known to be seropositive for human immunodeficiency virus (HIV).
    b. Known to be seropositive for hepatitis B virus (HBV; defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are positive for antibodies to hepatitis B core antigen [antiHBc] and/or antibodies to hepatitis B surface antigen [antiHBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded.
    EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (antiHBs) positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
    c. Known to be seropositive for hepatitis C virus (HCV; anti-HCV antibody positive or HCV-RNA quantitation positive), except in the setting of a sustained virologic response (SVR), defined as aviremia at least 12 weeks after completion of antiviral therapy.
    11. 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 if enrolled in the study.
    12. Has clinically significant cardiac disease, including:
    ● Myocardial infarction within 6 months before signing the informed consent form (ICF), or unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class IIIIV; Appendix 18)
    ● Uncontrolled cardiac arrhythmia or clinically significant electrocardiogram (ECG) abnormalities
    ● Screening 12-lead ECG showing a baseline QT interval as corrected by Frederica’s formula (QTcF) >470 msec.
    13. Received a strong CYP3A4 inducer within 5 half-lives prior to randomization
    14. Allergy, hypersensitivity, or intolerance to boron or mannitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients, or sensitivity to mammalian-derived products or lenalidomide.
    E.5 End points
    E.5.1Primary end point(s)
    Overall MRD negativity rate, which is defined as the proportion of subjects who have achieved MRD negative status (at 10^-5) by bone marrow aspirate after randomization and prior to progressive disease (PD) or subsequent anti myeloma therapy. Subjects who have achieved MRD negative status on or after PD or switch to subsequent anti-myeloma therapy before PD, will not be considered MRD negative in the primary endpoint analysis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    One year after the last subject is administered their first dose of study treatment
    E.5.2Secondary end point(s)
    1. PFS defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first. Disease progression will be determined according to the International Myeloma Working Group (IMWG) criteria. For subjects who have not progressed and are alive, data will be censored at the last disease evaluation before the start of any subsequent anti-myeloma therapy.
    2. MRD negativity rate at 1 year.
    3. Durable MRD negativity rate is defined as the proportion of subjects who have achieved MRD negative status (at 10^-5) at 2 bone marrow aspirate examinations that are a minimum of 1 year apart, without any examination showing MRD positive status in between.
    4. Overall response rate is defined as the proportion of subjects who achieve PR or better responses prior to subsequent anti-myeloma therapy in accordance with the IMWG criteria, during or after the study treatment.
    5. VGPR or better rate is defined as the proportion of subjects achieving VGPR and CR (including stringent complete response [sCR]) prior to subsequent anti-myeloma therapy in accordance with the IMWG criteria during or after the study treatment.
    6. CR or better rate is defined as the proportion of subjects achieving CR or sCR prior to subsequent anti-myeloma therapy in accordance with the IMWG criteria during or after the study treatment.
    7. Progression-free survival on the next line of therapy is defined as the time from randomization to progression on the next line of treatment or death, whichever comes first. Disease progression will be based on investigator judgment. Subjects who are still alive and not yet progressed on the next line of treatment will be censored on the last date of followup.
    8. Overall survival is measured from the date of randomization to the date of the subject’s death due to any cause. 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.
    9. Time to response is defined as the time between the randomization and the first efficacy evaluation at which the subject meets all criteria for PR or better.
    10. Duration of response is calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of PD, as defined in the IMWG evaluation before the start of any subsequent anti-myeloma therapy.
    11. Clinical efficacy (i.e., overall MRD negativity rate and PFS) of D-VRd in high-risk molecular subgroups compared with VRd alone.
    12. Change in health-related quality of life (HRQoL), symptoms, and functioning using 2 European Organization for Research and Treatment of Cancer (EORTC) questionnaires and utility and visual analog scale of the EuroQol Five Dimension Questionnaire (EQ-5D-5L).
    13. Pharmacokinetic concentrations of daratumumab.
    14. Incidence of anti-daratumumab antibodies.
    15. Prevalence and incidence of anti-rHuPH20 antibodies.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 7. & 11. From randomization to either PD or death, whichever comes first
    2. At 1 year
    3. From one year onwards
    4. 5. 6. 9. & 10. Screening (within 28 days before randomization), Every 3 weeks of Cycles 1-8, Every 4 weeks for 30 months then every 8 weeks until PD (Cycles 9 and above)
    8. From first dose of study drug until end of study (approximately 6 years 5 months)
    12. Day (D)1 of Cycles 1-8, D1 of every 3rd cycle until PD & Every 16 weeks & start of subsequent therapy & 4 weeks after start of subsequent therapy
    13. Predose on D1 of C1, C3, C9, C12, D4 on C1, C3 and at post-treatment week 4 & 8
    14. & 15. Predose on D1 of C1, C9, C12 and at post-treatment week 4 & 8
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity Analyses and Biomarkers Analyses
    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 No
    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 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.8.2.4Number 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    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
    Brazil
    Canada
    Czech Republic
    France
    Germany
    Israel
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Spain
    Turkey
    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 as the later date between the primary PFS analysis (162 events observed) and 5 years after the last subject is randomized.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 324
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    F.4.2.2In the whole clinical trial 360
    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)
    The sponsor will ensure that subjects benefiting from treatment with daratumumab will be able to continue receiving treatment after the end of the study.
    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 Decision2018-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-23
    P. End of Trial
    P.End of Trial StatusOngoing
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