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    Summary
    EudraCT Number:2017-002611-34
    Sponsor's Protocol Code Number:54767414MMY2036
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-08-04
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-002611-34
    A.3Full title of the trial
    A Randomized, Open-label, Multicenter, Multiphase Study of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, Administered in Combination with Daratumumab, Compared with Daratumumab Alone in Subjects with Relapsed or Refractory Multiple Myeloma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multiphase study assessing the anti-tumor activity and safety of JNJ-63723283 (an Anti-PD-1 monoclonal antibody) administered in combination with daratumumab, compared with daratumumab alone in subjects with relapsed or refractory Multiple Myeloma.
    A.4.1Sponsor's protocol code number54767414MMY2036
    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+31 715242110
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameJNJ-63723283
    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.3.9.1CAS number Not Assigned
    D.3.9.2Current sponsor codeJNJ-63723283
    D.3.9.3Other descriptive nameJNJ-63723283-AAA
    D.3.9.4EV Substance CodeSUB183887
    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 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: 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 DARZALEX
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International N.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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
    D.3.2Product code HuMax-CD38
    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 INNDARATUMUMAB
    D.3.9.1CAS number 945721-28-8
    D.3.9.2Current sponsor codeJNJ-54767414 (Daratumumab)
    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 number20
    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 typehuman monoclonal antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed or Refractory Multiple Myeloma (MM).
    E.1.1.1Medical condition in easily understood language
    Blood cancer formed by malignant plasma cells that develops in the bone marrow and is non-responsive to therapy or relapses following treatment.
    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 100000054086
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective:
    Part1 (Safety Run-in): To assess the safety of the combination of JNJ-63723283 and daratumumab.
    Part 2 (Phase 2): To compare the overall response rate (ORR) in subjects treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone.
    Part 3 (Phase 3): To compare progression-free survival (PFS) in subjects treated with JNJ-63723283 in combination with daratumumab versus daratumumab alone.

    E.2.2Secondary objectives of the trial
    Phase 2 & Phase 3:
    -To assess the safety of of the combination of JNJ 63723283 and daratumumab.
    -To compare the complete response (CR)/better rate & very good partial response (VGPR)/better rate; duration of response and time to response; the minimal residual disease (MRD)-negative rate of JNJ-63723283 in combination with daratumumab versus daratumumab alone.
    -To evaluate the pharmacokinetic & immunogenicity profile of JNJ-63723283 in combination with daratumumab & the profile of daratumumab alone or in combination with JNJ-63723283.
    -To compare PFS & OS of JNJ-63723283 in combination with daratumumab versus daratumumab alone.
    -To evaluate the ORR & OS.
    -To assess the disease-related symptoms,functioning,quality of life (QOL) and health status by using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) & European Quality of Life 5 Dimensions Questionnaire (EQ-5D-5L).



    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. At least 18 years of age.
    2. Have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) in any order during the course of treatment for multiple myeloma or have disease that is refractory to both a PI and an IMiD. (For subjects who have received more than 1 type of PI, their disease must be refractory to the most recent one.Similarly, for those who have received more than 1 type of IMiD, their disease must be refractory to the most recent one).
    3. Evidence of a response to at least 1 prior treatment regimen.
    4. Documented measurable disease for multiple myeloma at screening as defined by the criteria below:
    -IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
    -IgA, IgM, IgD, or IgE multiple myeloma: serum M-protein level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or
    -Light chain multiple myeloma without measurable disease in the serum or urine: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
    5. Have relapsed or refractory disease at time of enrollment as defined below:
    •Relapsed disease is defined as an initial response to previous treatment, followed by progressive disease (PD) by International Myeloma Working Group (IMWG) criteria >60 days after cessation of treatment.
    •Refractory disease is defined as <25% reduction in M-protein or PD by IMWG criteria during previous treatment or ≤60 days after cessation of treatment.
    6. Eastern Cooperative Oncology Group Performance Status (ECOG)performance status score of 0, 1, or 2.
    7. Adequate organ function (bone marrow, liver, renal)
    8. Willing and able to adhere to the prohibitions and restrictions specified in this protocol.
    9. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
    E.4Principal exclusion criteria
    Any potential subject who meets any of the following criteria will be excluded from the study:
    1. Received any of Anti-CD38 antibody, including daratumumab or Anti-PD-1 and anti-PD-L1 antibodies in the past.
    2. Clinically significant cardiac or pulmonary disease.
    3. Prior diagnosis of autoimmune disease with the exception of subjects:
    - With autoimmune thyroid disease or type 1 diabetes that is well controlled on a stable medication regimen
    - With vitiligo, alopecia, or resolved childhood asthma/atopy
    - With psoriasis not requiring systemic therapy
    - With transient autoimmune manifestations of an acute infectious disease that resolved upon treatment of the infectious agent.
    3. Unresolved Grade 3 or higher toxicity effects from previous treatment with immunotherapy
    4. Received any of the following prescribed medications or therapies within the specified period:
    - Antimyeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, prior to first administration of study drug. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) for palliative treatment prior to first administration of study drug.
    - An allogenic stem cell transplant (SCT) at any time; or autologous SCT within 12 weeks prior to first administration of study drug.
    - Other investigational agent (including investigational vaccines), participation in another clinical study with therapeutic intent, or used an invasive investigational medical device within 28 days or 5 pharmacokinetic half-lives of the investigational agent (whichever is longer) prior to first administration of study drug.
    - Systemic radiotherapy within 14 days prior to first administration of study drug.
    5. Plans to undergo a stem cell transplant prior to progression of disease on this study.
    6. History of malignancy (other than multiple myeloma) within 2 years prior to first administration of study drug
    7. Known or suspected of not being able to comply with the study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence of adverse events (including dose-limiting toxicities (DLTs) (Part 1 [Safety Run-in] Group)
    2. Overall response rate (ORR; as defined by IMWG response criteria (Part 2 [Phase 2] group)
    3. Progression-free survival (PFS) (Part 3 [Phase 3] group)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Evaluation after 6 subjects have received 1 treatment cycle (28 days).
    2. Evaluation after 80 subjects have received at least 4 treatment cycles.
    3. Primary Analysis after 138 PFS events.
    E.5.2Secondary end point(s)
    Phase2 & Phase 3 Groups:
    1. Incidence of adverse events, including immune-related AEs and infusion-related reactions
    2. Complete response (CR) or better rate (as defined by the IMWG response criteria)
    3. Very good partial response (VGPR) or better rate (as defined by the IMWG response criteria)
    4. Duration of response
    5. Time to response
    6. Progression-free survival (PFS)
    7. Incidence of anti-JNJ-63723283 antibodies
    8. Incidence of anti-daratumumab antibodies
    9. Overall survival (OS)
    10. MRD-negative rate
    11. Serum JNJ-63723283 Concentration (Cmin, Cmax)
    12. Serum daratumumab pharmacokinetic Concentration (Cmin, Cmax)
    Part 3 (Phase 3) Group:
    13. Overall response rate (ORR)
    14. Change from baseline in disease-related symptom scales, functioning scales, and Global Health Status (GHS) scale of the EORTC QLQ-C30, and the utility scale and visual analog scale (VAS) of the EQ-5D-5L



    E.5.2.1Timepoint(s) of evaluation of this end point
    1. After 50 subjects have been enrolled and have been treated for at least 8 weeks or discontinued the study treatment
    2 to 8. Part 2: At 12 months; Part 3: At 138 events
    9. Part 2: At 12 months; Part 3: After 205 deaths have been observed
    10. At the time of disease progression & at every 6 months in subjects with maintained CR & stringent complete response (sCR)
    11. Cycle (C)1 Day (D)1, C1 D2, D1 of C 2,3,5, 7,12,16 & 24; every 12 cycles thereafter until end of treatment (EOT)
    12. C1 D1, C1 D2, D1 of C 2,3,5, 7,12&24; every 12 cycles thereafter until EOT
    13. Part 2: At 12 months; Part 3: At 138 events
    14. D1 of every 3rd cycle (Cycles 3,6,9,12) until progressive disease (PD)

    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity and Biomarker 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) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Multicenter study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Belgium
    France
    Germany
    Greece
    Israel
    Russian Federation
    Spain
    Turkey
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days22
    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: 154
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 232
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 386
    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 provide standard of care treatment.
    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 Decision2017-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-16
    P. End of Trial
    P.End of Trial StatusOngoing
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