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    Summary
    EudraCT Number:2009-016871-32
    Sponsor's Protocol Code Number:0911001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-02-21
    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 number2009-016871-32
    A.3Full title of the trial
    A Randomized Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) to High-Dose Treatment with Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age (IFM/DFCI 2009)
    Etude de Phase III randomisée, comparant un traitement conventionnel comportant une association de Lénalidomide, Bortezomib et de Dexaméthasone (RVD) à un traitement haute dose avec autogreffe de cellules souches périphériques dans le traitement initial du myélome chez des patients d’âge inférieur ou égal à 65 ans (IFM/DFCI 2009)
    A.3.2Name or abbreviated title of the trial where available
    IFM/DFCI 2009
    IFM/DFCI 2009
    A.4.1Sponsor's protocol code number0911001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01191060
    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 SponsorCHU de TOULOUSE
    B.1.3.4CountryFrance
    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 supportPHRC National/Ministère de la Santé
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportCelgene International SARL
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportJanssen Pharmaceutica NV
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportAmgen
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Toulouse
    B.5.2Functional name of contact pointHUGUET Amandine
    B.5.3 Address:
    B.5.3.1Street Address2 rue viguerie
    B.5.3.2Town/ cityToulouse Cedex 9
    B.5.3.3Post code31059
    B.5.3.4CountryFrance
    B.5.6E-maillendrieux.a@chu-toulouse.fr
    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 (LENALIDOMIDE)
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited, Riverside House, Riverside Walk, Windsor, Berkshire, SL4 1NA, Royaume-Uni
    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 nameREVLIMID (LENALIDOMODE)
    D.3.4Pharmaceutical form Gastro-resistant capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    Oral 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.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25 to mg
    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 REVLILMID (LENALIDOMIDE)
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Limited, Riverside House, Riverside Walk, Windsor, Berkshire, SL4 1NA, Royaume-Uni
    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 nameREVLIMID (LENALIDOMIDE)
    D.3.4Pharmaceutical form Gastro-resistant capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    Oral 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.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 to mg
    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 VELCADE (BORTEZOMIB)
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG International
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameVELCADE (BORTEZOMIB)
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) Information not present in EudraCT
    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
    Myeloma, Multiple Myeloma
    E.1.1.1Medical condition in easily understood language
    Myeloma, Multiple Myeloma
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10028566
    E.1.2Term Myeloma
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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 compare progression-free survival (PFS) between Arm A and Arm B
    E.2.2Secondary objectives of the trial
    • To compare the response rates (RR) between the two arms
    • To compare time to progression (TTP) between the two arms
    • To compare the overall survival (OS) between the two arms
    • To compare the toxicity between the two arms
    • To define genetic prognostic groups evaluated by gene expression profiling (GEP)
    • To examine the best treatment in each Gene Expression Profile-defined prognostic group
    • To compare quality of life (QOL) between the two arms
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •All laboratory assessments should be performed within 21 days of
    initiation of protocol therapy:
    • Participants must have a diagnosis of MM, according to International
    Myeloma Foundation 2003 Diagnostic Criteria. According to these
    criteria, all three of the following must be met with screening tests
    performed within 21 days of initiation of protocol therapy:
     Monoclonal plasma cells in the bone marrow > 10% (or proven
    plasmocytic infiltration in bone marrow biopsy)and/or presence of a
    biopsy-proven plasmacytoma
     Monoclonal protein (M-protein) present in the serum and/or urine.
     Myeloma-related organ dysfunction (1 or more) of the following. A
    variety of other types of end-organ dysfunctions can occasionally occur
    and lead to a need for therapy:
    [C] Calcium elevation in the blood, defined as serum calcium > 10.5
    mg/dl or upper limit of normal
    [A] Anemia, defined as hemoglobin <10 g/dl or 2 g < normal
    [B] Lytic bone lesions or osteoporosis. If a solitary (biopsy-proven)
    plasmacytoma or osteoporosis alone (without fractures) are the sole
    defining criteria, then > 30% plasma cells are required in the bone
    marrow or proven plasmocytic infiltration in bone marrow biopsy..
    Note: These criteria identify Stage IB and Stages II and III A/B
    myeloma by Durie-Salmon stage. Stage IA becomes smoldering or
    indolent myeloma.
    • Participants must have documented symptomatic myeloma with
    organ damage related to myeloma as defined above with laboratory
    assessments performed within 21 days of initiation of protocol therapy.
    • Participants must have myeloma that is measurable by either serum
    or urine evaluation of the monoclonal component or by assay of serum
    free light chains. Measurable disease is defined as one or more of the
    following: serum M-protein ≥ 1 g/dl, urine M-protein ≥ 200 mg/24 h,
    and/or serum FLC assay: involved FLC level ≥ 10 mg/dl with abnormal
    serum FLC ratio.
    • Age between 18 and 65 years at the time of signing the informed
    consent form.
    • ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix IV).
    • Negative HIV blood test within 21 days of initiation of protocol
    therapy. HIV-positive individuals on combination antiretroviral therapy
    are ineligible because of the potential for pharmacokinetic (PK)
    interactions with lenalidomide, bortezomib and/or dexamethasone. In
    addition, these individuals are at increased risk of lethal infections when
    treated with marrow-suppressive therapy.
    o Criteria for women of non-childbearing potential
    A female subject or a female partner of a male subject is considered to
    have childbearing potential unless she meets at least one of the
    following criteria:
    • Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year*
    • Premature ovarian failure confirmed by a specialist gynaecologist
    • Previous bilateral salpingo-oophorectomy, or hysterectomy
    • XY genotype, Turner syndrome, uterine agenesis.
    *Amenorrhoea following cancer therapy does not rule out childbearing
    potential.
    Female subjects of childbearing potential must follow the
    recommandations as precognized in the protocol.
    Male subjects must
    - Agree to use condoms throughout study drug therapy, during any
    dose interruption and for one week after cessation of study therapy if
    their partner is pregnant or of of childbearing potential and has no
    contraception.
    - Agree not to donate semen during study drug therapy and for one
    week after end of study drug therapy.
    All subjects must
    - Agree to abstain from donating blood while taking study drug therapy
    and for one week following discontinuation of study drug therapy.
    - Agree not to share study medication with another person and to
    return all unused study drug to the investigator.
    • Ability to understand and the willingness to sign a written informed
    consent document. Voluntary written informed consent must be obtained
    before performance of any study-related procedure not part of normal
    medical care, with the understanding that consent may be withdrawn by
    the participant at any time without prejudice to future medical care.
    E.4Principal exclusion criteria
    All laboratory assessments should be performed within 21 days of initiation of protocol therapy:
    • Participant treated with any prior systemic therapy. Treatment by localized radiotherapy is not an exclusion
    criterion if an interval of at least two weeks between the end of radiotherapy and initiation of protocol therapy is
    observed. Similarly, the dose of corticosteroids received by the participant as part of any initial therapy should
    not exceed the equivalent of 160 mg of dexamethasone over a two-week period before initiation of protocol
    therapy (see Appendix V for equivalence table).
    • Primary amyloidosis (AL) or myeloma complicated by amylosis.
    • Participants receiving any other investigational agents.
    • Participants with known brain metastases should be excluded from this clinical trial because of their poor
    prognosis and because they often develop progressive neurologic dysfunction that would confound the
    evaluation of neurologic and other adverse events.
    • Poor tolerability or known allergy to any of the study drugs or compounds of similar chemical or biologic
    composition to lenalidomide, bortezomib and/or dexamethasone.
    • Participants with platelet level <50,000/mm3. Transfusion within 7 days of screening is not allowed to meet
    platelet eligibility criteria
    • Participants with an absolute neutrophil count (ANC) <1000/uL. Growth factor within 7 days of screening is
    not allowed to meet ANC eligibility criteria.
    • Participants with hemoglobin level < 8.0 g/dL. Transfusion may be used to meet hemoglobin eligibility criteria.
    • Hepatic impairment, defined as bilirubin > 1.5 ? Institutionnal ULN Total Bilirubin (Patients with benign
    hyperbilirubinemia (e.g., Gilbert’s syndrome) are eligible ) or AST (SGOT), or ALT (SGPT), or alkaline
    phosphatase ≥ 2x ULN
    • Renal insufficiency, defined as serum creatinine > 170 µmol and/or creatinine clearance < 50 mL/min (either
    actual or calculated values may be used). The Cockgroft-Gault formula should be used for calculating creatinine
    clearance values:
    (140-age) x Body mass (kg) x 0.85 (female) or 1.0 (male)
    serum creat (mg/dL) x 72
    • Respiratory compromise, defined as ventilation tests with DLCO < 50%
    • Participant with clinical signs of heart or coronary failure, or evidence of left ventricular ejection fraction
    (LVEF) < 40%. Participant with myocardial infarction within 6 months prior to enrollment or have New York
    Heart Association (NYHA Appendix VII) Class III or IV heart failure, uncontrolled angina, severe uncontrolled
    ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conductive system
    abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator
    as not medically relevant
    • Intercurrent illness including, but not limited to ongoing or active severe infection, known (active or not)
    infection with hepatitis B or C virus, poorly controlled diabetes, or severe uncontrolled psychiatric disorder or
    psychiatric illness/social situations that would limit compliance with study requirements.
    • Participants with previous history of another malignant condition. If malignancy was experienced more tha 10 years an confirmed as cured, these participants may be considered for the study on cse by case basis with PI discussion.
    • Female participants pregnant or breast-feeding. Pregnant women are excluded from this study because
    lenalidomide is an immunomodulatory agent with the potential for teratogenic or abortifacient effects. Because
    there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother
    with lenalidomide, breastfeeding should be discontinued if the mother is treated with lenalidomide. These
    potential risks may also apply to other agents used in this study. Lactating females must agree not to breast feed
    while taking lenalidomide
    • Inability to comply with an anti-thrombotic treatment regimen (e.g., administration of low weight heparin type
    innohep® or equivalent)
    • Peripheral neuropathy ≥ Grade 2 on clinical examination within 21 days of initiation of protocol therapy.
    • Adults under juridical protection
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this randomized phase III study is to compare the progression-free survival (PFS) of
    Arm A (conventional dose arm) and Arm B (high dose therapy arm) in newly diagnosed myeloma patients
    who have completed 1 cycle of RVD. PFS is defined as the time from randomization until progression or
    death from any cause. Patients alive without confirmed progression will be censored at the time of the last
    disease evaluation. Deaths without progression are counted as failures even if they occur after the last disease
    evaluation. Patients are stratified by county (US vs. IFM), cytogenetics risk factors (standard, high risk, FISH
    failures) and ISS (Stage I vs. II vs. III). Patients will be randomized equally to the two arms using permuted
    blocks within stratification combinations.
    E.5.1.1Timepoint(s) of evaluation of this end point
    progression Free Survival [Time frame : up to 4 years or until progression ]
    E.5.2Secondary end point(s)
    The secondary objectives of the study are to compare the following outcomes between the two arms: the response
    rates (CR, at least VGPR), time to progression, overall survival, toxicity, and quality of life. The reasons
    that participants who received 1 cycle of therapy did not proceed to the randomization will be collected and
    reported. Prognostic groups defined by gene expression profiling will be defined in correlative studies. Time to
    progression (TTP) is defined as the time from randomization until progression. Patients who have died without
    evidence of progression are censored in the TTP analysis and patients who are alive without progression are
    censored at the last disease assessment. Overall survival is defined as the time of randomization to death.
    Patients are censored at the time last known alive. The planned sample size is 1000 eligible patients over 36
    months for accrual rate of 27-28 patients/month
    E.5.2.1Timepoint(s) of evaluation of this end point
    Response Rates [ Time Frame: up to 4 years or until progression ]
    Time To Progression [ Time Frame: up to 4 years or until progression ]
    Toxicity comparison [ Time Frame: from randomization up to 4 years or
    until progression ]
    Genetic prognostic groups definition [ Time Frame: from randomization
    up to 4 years or until progression ]
    Best treatment examination in each GEP-defined prognostic group. [
    Time Frame: from randomization up to 4 years or until progression ]
    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 No
    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 Yes
    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
    strategy of the study : VRD +/- AG : Arm A and B
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA81
    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
    Switzerland
    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
    last visit of last subject
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 state686
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 699
    F.4.2.2In the whole clinical trial 700
    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)
    Normal care of myeloma's pathology
    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 Decision2011-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-30
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