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    Summary
    EudraCT Number:2008-004083-39
    Sponsor's Protocol Code Number:DSMM_XIII
    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:2009-04-15
    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 number2008-004083-39
    A.3Full title of the trial
    The combination of Lenalidomide and Dexamethasone with or without intensification by high-dose Melphalan in the treatment of multiple myeloma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The combination of Lenalidomide and Dexamethasone with or without intensification by high-dose Melphalan in the treatment of multiple myeloma
    A.4.1Sponsor's protocol code numberDSMM_XIII
    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 SponsorGMIHO Gesellschaft für Medizinische Innovation – Hämatologie und Onkologie mbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelgene
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGMIHO Gesellschaft für Medizinische Innovation – Hämatologie und Onkologie mbH
    B.5.2Functional name of contact pointGMIHO
    B.5.3 Address:
    B.5.3.1Street AddressAlexanderplatz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10178
    B.5.3.4CountryGermany
    B.5.4Telephone number0049302787 60890
    B.5.5Fax number0049302787 608918
    B.5.6E-mailinfo@gmiho.de
    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 Yes
    D.2.1.1.1Trade name Revlimid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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/3/03/177
    D.3 Description of the IMP
    D.3.1Product nameLenalidomide
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLenalidomide
    D.3.9.2Current sponsor codeR
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 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 Revlimid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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/3/03/177
    D.3 Description of the IMP
    D.3.1Product nameLenalidomide
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLenalidomide
    D.3.9.2Current sponsor codeR
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 Revlimid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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/3/03/177
    D.3 Description of the IMP
    D.3.1Product nameLenalidomide
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLenalidomide
    D.3.9.2Current sponsor codeR
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    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 nameDexamethasone
    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 50022
    D.3.9.2Current sponsor codeDexamethasone
    D.3.9.3Other descriptive named
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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: 5
    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.2.1.2Country 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 nameMelphalan
    D.3.2Product code Mel
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNMELPHALAN
    D.3.9.1CAS number 148823
    D.3.9.2Current sponsor codeMel
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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: 6
    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 Revlimid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited
    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/3/03/177
    D.3 Description of the IMP
    D.3.1Product nameLenalidomide
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLenalidomide
    D.3.9.1CAS number 191732-72-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.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
    primary treatment of multiple myeloma patients of age 60 till 75 years
    E.1.1.1Medical condition in easily understood language
    Erstbehandlung des Multiplen Myeloms bei Patienten im Alter von 60 bis 75 Jahren
    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
    To compare the efficacy of both treatment regimens with regard to progression-free
    survival.
    E.2.2Secondary objectives of the trial
    • To assess the safety and overall survival of both treatment regimens.
    • To investigate other efficacy parameters of both treatment regimens.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Understand and voluntarily sign an informed consent form
    2. Age 60-75 years.
    3. Able to adhere to the study visit schedule and other protocol requirements.
    4. Symptomatic multiple myeloma requiring therapy
    5. Measurable monoclonal protein present in serum and/or urine
    6. Monoclonal plasma cells in the bone marrow ≥ 10% and/or biopsy-proven plasmacytoma
    7. Myeloma-related organ dysfunction, at least one of
    [C] Calcium elevation in the serum (> 11.5 mg/dL or > 2.65 mmol/l)
    [R] Renal insufficiency (creatinine > 2mg/dL or > 173 µmol/l)
    [A] Anemia (Hb < 10 g/dL or 2 g/dL < normal)
    [B] Bone lesions or general osteoporosis
    8. ECOG performance status of ≤ 2 at time of randomization
    9. Laboratory test results within these ranges within 1 week prior to
    randomization/registration:
    • Absolute neutrophil count ≥ 1.0x10e9/L
    • Platelet count ≥ 75 x 10e9/L or in case of bone marrow infiltration with myeloma cells ≥ 30x10e9/L
    • Total bilirubin ≤ 2mg/dL
    • AST and ALT ≤ 3xULN
    10. Female subjects of childbearing potential must:
    o Understand the study drug has a teratogenic risk to the unborn child
    o Agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time
    periods related to this study: 1) for at least 28 days before starting
    lenalidomide; 2) while taking lenalidomide; 3) during dose
    interruptions; and 4) for at least 28 days after last dose of
    lenalidomide . The two methods of reliable contraception must
    include one highly effective method and one additional effective
    (barrier) method. The following are examples of highly effective and additional effective methods of contraception:
    Examples of highly effective methods:
    - Intrauterine device (IUD)
    - Hormonal (birth control pills, injections, implants, levonorgestrel-releasing intrauterine System [IUS], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills [e.g.
    desogestrel]))
    - Tubal ligation
    - Partner’s vasectomy
    Examples of additional effective methods:
    - Male condom
    - Diaphragm
    - Cervical Cap
    o Agree to have two medically supervised negative pregnancy tests
    (sensitivity of at least 25 mIU/mL) prior to starting lenalidomide. The
    first pregnancy test must be performed within 10 to 14 days prior to
    the start of lenalidomide and the second pregnancy test must be
    performed within 24 hours prior to the start of lenalidomide. The
    patient may not receive lenalidomide until the study doctor has
    verified that the results of these pregnancy tests are negative. This
    requirement also applies to women of childbearing potential who
    practice complete and continued abstinence. The test should ensure the subject is not pregnant when she starts treatment.
    o Agree to have a medically supervised pregnancy test weekly for the
    first 28 days of study participation and then every 28 days while taking
    lenalidomide, at study discontinuation, and at day 28 following the last dose of lenalidomide. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days of study participation and then every 14 days while taking lenalidomide, at study discontinuation, and at days 14 and 28 following the last dose of
    lenalidomide.
    o Should not donate blood while receiving lenalidomide, during dose
    interruptionsand for at least 28 days after the last dose of lenalidomide.
    o Counseling about pregnancy precautions and the potential risks of
    fetal exposure must be conducted at a minimum of every 28 days.
    o If pregnancy or a positive pregnancy test does occur in a study patient, lenalidomide must be immediately discontinued.
    o Pregnancy testing and counseling must be performed if a patient
    misses her period or if her pregnancy test or her menstrual bleeding is
    abnormal. Lenalidomide must be discontinued during this evaluation.
    o Females must agree to abstain from breastfeeding while taking
    lenalidomide and for at least 28 days after the last dose of
    lenalidomide.
    Male subjects
    o Must understand the potential teratogenic risk if engaged in sexual
    activity with a pregnant female or a FCBP.
    o Must practice complete abstinence or use a condom during sexual contact with a pregnant female or a female of childbearing potential while taking lenalidomide, during dose interruptions and for at least 28 days after the last dose of lenalidomide, even if he has undergone a successful vasectomy.
    o Must not donate blood, semen or sperm while receiving lenalidomide, during dose interruptions or for at least 28 days after the last dose of lenalidomide.
    11. Disease free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast.
    12. Able to receive antithrombotic prophylaxis.
    13. Life-expectancy > 3 months.
    E.4Principal exclusion criteria
    1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
    would prevent the subject from signing the informed consent form.
    2. Pregnant or lactating females
    3. Any condition, including the presence of laboratory abnormalities, which places
    the subject at unacceptable risk if he/she were to participate in the study or
    confounds the ability to interpret data from the study
    4. Patient currently is enrolled in another clinical research study or has been enrolled
    in such a study within 4 weeks before randomization and/or is receiving an investigational agent for any reason or has received such an agent
    within 4 weeks before randomization/registration
    5. Known hypersensitivity to thalidomide, dexamethasone, or melphalan
    6. The development of erythema nodosum if characterized by a desquamating rash
    while taking thalidomide or similar drugs
    7. Any prior use of lenalidomide
    8. Concurrent use of other anti-cancer agents or treatments, with the exception of radiotherapy to restricted areas
    9. Known positive for HIV; active or chronic hepatitis A, B or C infection (including patients who are tested anti-HBc positive and/or HBsAg positive) - serological testing for hepatitis A, B, C required
    10. Prior treatment with dexamethasone discontinued because of ≥ grade 3
    dexamethasone-related toxicity
    11. Any prior chemotherapy with the exception of a short course of dexamethasone for symptom control
    12. Immunotherapy or antibody therapy within 8 weeks before
    randomization
    13. Major surgery within 4 weeks before randomization
    14. Renal failure requiring dialysis
    15. Myocardial infarction within 6 months before randomization/registration, NYHA Class III or IV heart failure, uncontrolled angina, severe
    uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
    ischemia or active conduction system abnormalities
    16. Severe pulmonary disease (diffusion capacity < 50% of normal)
    17. Treatment for cancer other than multiple myeloma within 5 years before
    randomization, with the exception of basal cell carcinoma or cervical
    cancer in situ
    18. Cardiac amyloidosis
    19. Poorly controlled hypertension, diabetes mellitus, or other serious medical or
    psychiatric illness that could potentially interfere with the completion of treatment
    according to the protocol
    20. Any systemic infection requiring treatment
    21. Unability or unwillingness of the patient to receive antithrombotic prophylaxis
    E.5 End points
    E.5.1Primary end point(s)
    progression-free survival (PFS) from the time point of randomization
    E.5.2Secondary end point(s)
    - Overall survival (OS)
    - Response (complete response [CR], stringent complete response [sCR] very good
    partial response [VGPR], partial response [PR], and overall response [CR
    (including sCR) + VGPR + PR]) according to IMWG criteria (27).
    - Duration of response
    - Time to response
    - Safety (adverse events, laboratory abnormalities, and hospitalizations)
    - Time to treatment failure (TTF)
    - Time to progression (TTP)
    - Time to second-line anti-myeloma treatment
    - Relationship of cytogenetic findings in the malignant myeloma clone at baseline
    to clinical outcomes
    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 No
    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) 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 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.8.2.3.1Comparator description
    comparisan of lenalidomide and dexamethason with or w/o intensification by high-dose melphalan
    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 concerned40
    E.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state348
    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 Decision2009-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-19
    P. End of Trial
    P.End of Trial StatusOngoing
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