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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41232   clinical trials with a EudraCT protocol, of which   6757   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2011-005709-62
    Sponsor's Protocol Code Number:GEN503
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-29
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2011-005709-62
    A.3Full title of the trial
    An Open label, International, Multicenter, Dose Escalating Phase 1/2 Trial Investigating the Safety of Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Daratumumab Open label, dose-escalation safety study in Combination with Lenalidomide and Dexamethasone in Patients with multiple myeloma
    A.3.2Name or abbreviated title of the trial where available
    Daratumumab in combination with lenalidomide and dexamethasone in relapsed and relapsed-refractory
    A.4.1Sponsor's protocol code numberGEN503
    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 CM
    B.5.4Telephone number+3171 524 2166
    B.5.5Fax number+3171 524 2110
    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
    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 codeDaratumumab
    D.3.9.3Other descriptive nameHuMax-CD38
    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. 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 Yes
    D. 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 Relapsed and Refractory Multiple myeloma
    E.1.1.1Medical condition in easily understood language
    Multiple myeloma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To establish the safety profile of daratumumab when given in combination with Len/Dex in subjects with relapsed or relapsed and refractory multiple myeloma
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of daratumumab when given in combination with Len/Dex in subjects with relapsed or relapsed and refractory multiple myeloma
    • To evaluate the PK profile of daratumumab when given in combination with Len/Dex in subjects with relapsed or relapsed and refractory multiple myeloma
    • To assess the immunogenicity of daratumumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Before entering Phase 1 of the study, subjects must:
    1. Have relapsed multiple myeloma after receiving a minimum of 2 and a maximum of 4 prior lines of therapy and be eligible for treatment with Len/Dex.
    2. Have measurable levels of M component, defined as serum M
    component≥ 1.0 g/dL and/or urine M component ≥ 200 mg/24 hour
    3. Be ≥ 18 years of age.
    4. Have an Eastern Cooperative Oncology Group (ECOG) performance
    status of 0, 1, or 2 (Attachment 1).
    5. Have a life expectancy of ≥ 3 months.
    6. Provide signed informed consent after receipt of oral and written
    information about the study and before any study-related activity is
    Before entering Phase 2 of the study, subjects must:
    1.-Have received at least 1 prior line of therapy for multiple myeloma (refer to Attachment 2).
    - Have achieved a response (PR or better) to at least one prior regimen.
    - Have documented evidence of progressive disease (PD) as defined by the IMWG criteria on or after their last regimen.
    2. Have measurable levels of M component, defined as serum M
    component ≥ 1.0 g/dL and/or urine M component ≥ 200 mg/24 hour
    3. Be ≥ 18 years of age.
    4. Have an ECOG performance status score of 0, 1, or 2
    (Attachment 1).
    5. Have a life expectancy of ≥ 3 months.
    6. Provide signed informed consent after receipt of oral and written
    information about the study and before any study-related activity is
    E.4Principal exclusion criteria
    1. Have previously received an allogenic stem cell transplant.
    2. Have received auto SCT within 12 weeks before the first infusion.
    3. Have received antimyeloma treatment, radiotherapy, or any
    experimental drug or therapy within 2 weeks before the first infusion.
    4.Have discontinued lenalidomide due to any treatment-related adverse event or be refractory to any dose of lenalidomide.
    Refractory to lenalidomide is defined as either:
    - Subjects whose disease progresses within 60 days of lenalidomide, or
    - Subjects whose disease is nonresponsive while on any dose of
    lenalidomide. Nonresponsive disease is defined as either failure to
    achieve at least an MR or development of PD while on lenalidomide.
    5. Have experienced prior DVT of Grade ≥ 3 according to the National
    Cancer Institute's Common Terminology Criteria for Adverse Events,
    version 4.0 (CTCAE).
    6. Have experienced prior PE.
    7. Have had past or current malignancy, except for:
    -cervical carcinoma of Stage 1B or less;
    -noninvasive basal cell or squamous cell skin carcinoma;
    -malignant melanoma with a CR of > 10 years duration;
    -prostate cancer with a current prostate-specific antigen level < 0.1
    -any curable cancer with a CR of > 5 years duration.
    8. Have any current serious infectious disease requiring systemic
    9. Have clinically significant cardiac disease, including:
    -unstable angina;
    -acute myocardial infarction within 6 months of the Screening Visit
    (before the first infusion);
    -congestive heart failure (Class III or IV as classified by the New York
    Heart Association; Attachment 3);
    -a known decreased cardiac ejection fraction of < 50%;
    -a screening 12-lead electrocardiogram (ECG) reading showing a
    baseline QT interval as corrected by Fridericia's formula (QTcF) > 470
    msec for females or > 450 msec for males or a complete left bundle
    branch block (defined as a QRS interval ≥ 120 msec in left bundle branch block form).
    10. Have a significant, concurrent, uncontrolled medical condition
    including, but not limited to, renal (except as related to multiple
    myeloma), hepatic, hematologic (except as related to multiple
    myeloma), gastrointestinal, endocrine, pulmonary, neurologic,
    cerebral, or psychiatric disease.
    11. Be exhibiting clinical signs of meningeal involvement of multiple
    12. Have known severe chronic obstructive pulmonary disease or asthma (defined as a forced expiratory volume in 1 second [FEV1] <60% of predicted normal) or persistent asthma.
    13. Have a history of significant cerebrovascular disease.
    14. Have known to be seropositive for human immunodeficiency virus (HIV) or have active hepatitis B or hepatitis C.
    15. Have screening laboratory test results as the following:
    -absolute neutrophil count ≤ 1.5 10^9/L;
    -hemoglobin level ≤ 80 g/L (≤ 5 mmol/L);
    -platelet count < 75 10^9/L
    -alanine aminotransferase (ALT) ≥ 2.5 times the upper limit of normal
    -alkaline phosphatase level ≥ 2.5 × ULN;
    -direct bilirubin level ≥ 2 × ULN;
    -creatinine clearance (CrCl) ≤ 60 mL/min within 7 days before the
    Screening Visit (before the first infusion);
    -potassium level < 3.0 mEq/L.
    16. Have received granulocyte-colony stimulating factor (G-CSF) or
    granulocyte/macrophage-colony stimulating factor support for < 1 week
    or pegylated G-CSF for < 2 weeks before the Screening Visit or before
    the first infusion.
    17. Have received a cumulative dose of corticosteroid ≥ 200 mg
    (dexamethasone, or equivalent doses of prednisone) within 2 weeks
    before the first infusion.
    18. Have a known hypersensitivity to components of the study drug or
    combination therapy, or have known allergies, hypersensitivity, or
    intolerance to monoclonal antibodies or human proteins, or their
    excipients (refer to Investigator Brochure 2013), or have known
    sensitivity to mammalian-derived products.
    19. Have plasma cell leukemia or Waldenström's macroglobulinemia.
    20. Have previously received daratumumab, or other anti-CD38
    21. Be known to have any contraindications to receiving lenalidomide
    (as specified in the lenalidomide label).
    22. Have received treatment with any nonmarketed drug substance
    within 4 weeks before the first infusion.
    23. Be currently participating in any other interventional clinical study.
    24. Be known or suspected of not being able to comply with the study protocol (eg, because of alcoholism, drug dependency, or psychological disorder).
    25. Be breastfeeding female.
    26. Have a positive pregnancy test at the Screening Visit or before the
    first infusion.

    Please see the protocol for a full list of the exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events (AE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At end of trial and as part of preparations for subsequent trials,
    exploratory analysis of subsets of data may be performed.
    E.5.2Secondary end point(s)
    - The rate of response
    - Pharmacokinetic parameters
    - Time to progression
    - Duration of response- Survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    At end of trial and as part of preparations for subsequent trials, exploratory analysis of subsets of data may be performed.
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E. trial type description
    Dose escalation study
    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 Yes
    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) 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    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 trial is the last patient last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years11
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days26
    E.8.9.2In all countries concerned by the trial years11
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days26
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 50
    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 investigator, in consultation with the subject, will decide the future course of treatment for MM.
    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 Decision2012-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-12-06
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