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    Summary
    EudraCT Number:2015-001183-19
    Sponsor's Protocol Code Number:GEM-CLARIDEX
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-07-31
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-001183-19
    A.3Full title of the trial
    Lenalidomide and dexamethasone (Ld) versus Clarithromycin / Lenalidomide [Revlimid®] / Dexamethasone (BiRd) as initial therapy in Multiple Myeloma.
    Lenalidomida y dexametasona (Ld) versus Claritromicina / Lenalidomida [Revlimid®] / Dexametasona (BiRd) como tratamiento inicial del Mieloma Múltiple.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Lenalidomide and dexamethasone (Ld) versus Clarithromycin / Lenalidomide [Revlimid®] / Dexamethasone (BiRd) as initial therapy in Multiple Myeloma.
    Lenalidomida y dexametasona (Ld) versus Claritromicina / Lenalidomida [Revlimid®] / Dexametasona (BiRd) como tratamiento inicial del Mieloma Múltiple.
    A.3.2Name or abbreviated title of the trial where available
    GEM-CLARIDEX
    GEM-CLARIDEX
    A.4.1Sponsor's protocol code numberGEM-CLARIDEX
    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 SponsorFundación PETHEMA
    B.1.3.4CountrySpain
    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.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCABYC, S.L.
    B.5.2Functional name of contact pointInvestigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Somosierra, 12. Portal Izdo., 2ºG
    B.5.3.2Town/ citySan Sebastián de los Reyes (Madrid)
    B.5.3.3Post code28703
    B.5.3.4CountrySpain
    B.5.4Telephone number+34916590433-
    B.5.5Fax number+34916548969-
    B.5.6E-mailjuan.berges@cabyc.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 Yes
    D.2.1.1.1Trade name REVLIMID® 5mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LTD.
    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.3.4Pharmaceutical 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.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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® 10mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LTD.
    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.3.4Pharmaceutical 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.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration 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® 15mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE, LTD.
    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.3.4Pharmaceutical 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.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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.2.1.1.1Trade name REVLIMID® 20mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE, LTD
    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.3.4Pharmaceutical 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.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.2.1.1.1Trade name REVLIMID® 25mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderCELGENE EUROPE LTD.
    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.3.4Pharmaceutical 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.3.9.4EV Substance CodeSUB25389
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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: 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 FORTECORTÍN® 8mg comprimidos
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical 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 50-02-2
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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: 7
    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 CLARITROMICINA NORMON® 500mg Comprimidos recubiertos
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS NORMON, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Coated 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 INNCLARITHROMYCIN
    D.3.9.1CAS number 81103-11-9
    D.3.9.3Other descriptive nameCLARITHROMYCIN
    D.3.9.4EV Substance CodeSUB06641MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Multiple Myeloma
    Mieloma Múltiple
    E.1.1.1Medical condition in easily understood language
    Multiple Myeloma
    Mieloma Múltiple
    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 18.0
    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 compare efficacy of the BiRd regimen vs Rd
    Comparar la eficacia del régimen BiRd versus Rd.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of clarithromycin, lenalidomide (Revlimid®), and dexamethasone combination therapy (BiRd), compared to lenalidomide and dexamethasone (Rd) alone as an induction therapy for patients with newly diagnosed, transplant ineligible, previously untreated MM.
    - To compare ORR of BiRd versus Rd.
    - To determine and compare the following: DOR, EFS, TTP, and OS of BiRd versus Rd.
    - To assess safety and drug toxicity in each arm.
    - To determine relative dose intensity for each component of protocol medication prescribed.
    - To evaluate and compare minimal residual disease following therapy of BiRd versus Rd.
    - To determine and compare the efficacy of BiRd versus Rd from study entry until 2nd instance of disease progression.
    - To assess determine and compare quality of life assessments for BiRd vs Rd.
    - Evaluar la eficacia de la combinación de claritromicina, lenalidomida (Revlimid®), y dexametasona (BiRd), en comparación con lenalidomida y dexametasona (Rd) solamente, como tratamiento de inducción para pacientes con MM de nuevo diagnóstico, no elegibles para trasplante y sin tratamiento previo para MM.
    - Comparar la Tasa de Respuesta Global (TRG) de BiRd frente a Rd.
    - Determinar y comparar lo siguiente: DDR, EFS, THP, y SG de BiRd frente a Rd.
    - Evaluar la seguridad y toxicidad en cada brazo de tratamiento.
    - Determinar la intensidad de dosis relativa para cada componente del tratamiento del estudio.
    - Evaluar y comparar la enfermedad mínima residual tras el tratamiento con BiRd comparando los resultados con los de Rd.
    - Determinar y comparar la eficacia de BiRd frente a Rd desde el inicio del estudio hasta el segundo episodio de progresión de la enfermedad (SLP2).
    - Evaluar, determinar y comparar los cuestionarios de calidad de vida de BiRd frente a Rd.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must voluntarily sign and understand written informed consent.
    2. Subject is ? 65 years at the time of signing the consent form.
    3. Subject has histologically confirmed MM that has never before been treated, and according to the following definition of MM:
    Clonal bone marrow plasma cells ? 10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma defining events:
    1. Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically:
    - Hypercalcaemia: serum calcium > 0,25 mmol/L (> 1mg/dL) higher than the upper limit of normal or > 2,75 mmol/L (>11 mg/dL)
    - Renal insufficiency: creatinine clearance < 40 mL per min or serum creatinine > 177 µmol/L (>2 mg/dL)
    - Anaemia: haemoglobin value of > 20 g/L below the lower limit of normal, or a haemoglobin value < 100 g/L.
    - Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT.
    2. Any one or more of the following biomarkers of malignancy:
    - Clonal bone marrow plasma cell percentage ? 60%
    - Involved:uninvolved serum free light chain ratio ? 100
    - > 1 focal lesions on MRI studies
    4. Subject has no prior anti-myeloma treatment therapy within 14 days prior to initiation of study treatment except for corticosteroids with a maximum allowed dosage equivalent to three pulses of dexamethasone (40mg daily for 4 days equals one pulse).
    5. Patients may have received prior adjuvant antiresorptive therapy (i.e., pamidronate or zoledronic acid) as routine care, or radiation therapy as palliation for pain and/or spinal cord compression
    6. Subject has measurable disease as defined by > 0.5 g/dL serum monoclonal protein, > 10 mg/dL involved serum free light chain (either kappa or lambda) provided that the serum free light chain ratio is abnormal, >0 .2 g/24 hrs urinary M-protein excretion, and/or measurable plasmacytoma(s) of at least 1cm in greatest dimension as measured by either CT scanning or MRI.
    7. Subject has a Karnofsky performance status ? 60% (> 50% if due to bony involvement of myeloma).
    8. Subject is able to take prophylactic anticoagulation (patients intolerant to aspirin may use warfarin, acenocumarol or low molecular weight heparin).
    9. If subject is a female of childbearing potential (FCBP), she must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 ? 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with FCBP even if they have had a successful vasectomy.
    10. Subject has a life expectancy ? 3 months
    11. Subjects must meet the following laboratory parameters:
    - Absolute neutrophil count (ANC) ? 1.0 x 10^9/L.
    - Hemoglobin ? 7 g/dL.
    - Platelet count ? 75.000/mm3 ( > 30 x 10^9/L if extensive bone marrow infiltration).
    - Serum SGOT/AST < 3.0 x upper limits of normal (ULN).
    - Serum SGPT/ALT < 3.0 x upper limits of normal (ULN).
    - Serum total bilirubin < 2.0 mg/dL (34 µmol/L).
    - Creatinine clearance ? 45 cc/min.
    1. El paciente tendrá que firmar voluntariamente y entender el consentimiento informado por escrito.
    2. El paciente deberá tener ? 65 años en el momento de la firma del consentimiento.
    3. Al paciente se le ha confirmado un MM que nunca se ha tratado previamente, y de acuerdo a la siguiente definición de mieloma múltiple:
    Presencia de ? 10% de células plasmáticas clonales en médula ósea o plasmocitoma óseo o extramedular evidenciado mediante biopsia, y uno o más de los siguientes acontecimientos definitorios del mieloma:
    1. Evidencia de daño orgánico final que puede atribuirse al trastorno proliferativo de células plasmáticas subyacente, en concreto:
    - Hipercalcemia: calcio sérico > 0,25mmol/L (> 1mg/dL) por encima del límite superior de normalidad, o > 2,75mmol/L (> 11mg/dL)
    - Insuficiencia renal: aclaramiento de creatinina < 40mL por minuto, o creatinina sérica > 177µmol/L (> 2mg/dL)
    - Anemia: valor de hemoglobina > 20g/L por debajo del límite inferior de normalidad, o valor de hemoglobina < 100g/L.
    - Lesiones óseas: una o más lesiones osteolíticas en radiografía, TC o PET-TC.
    2. Uno o más de los siguientes biomarcardores de malignidad:
    - Porcentaje de células plasmáticas clonales en médula ósea ? 60%.
    - Ratio entre cadenas ligeras libres en suero involucradas y no involucradas ? 100.
    - > 1 lesión focal en Resonancia Magnética de cuerpo entero o de columna y pelvis.
    4. El paciente no debe haber recibido antes tratamiento anti-mieloma en los 14 días previos al inicio del tratamiento del estudio a excepción de los corticoides con una dosis máxima permitida equivalente a tres pulsos de dexametasona (40 mg diarios durante 4 días equivalen a un pulso).
    5. Los pacientes podrán haber recibido previamente tratamiento antirresortivo adyuvante (es decir, pamidronato o ácido zoledrónico) como tratamiento estándar, o radioterapia como tratamiento paliativo para el dolor y/o compresión de la médula espinal.
    6. El paciente tiene una enfermedad medible definida por > 0.5 g/dL de proteína monoclonal sérica, > 10 mg/dL de cadenas ligeras libres en suero involucradas (bien sean kappa o lambda), siempre y cuando la proporción de cadenas ligeras libres en suero sea anormal, excreción urinaria de proteína M > 0.2 g/24 horas y/o plasmocitoma(s) medible(s) de al menos 1cm en su dimensión mayor medidos bien sea por una Exploración con Tomografía Computarizada (TC) o por Resonancia Magnética (RM).
    7. El paciente tiene un Estado Funcional de Karnofsky ? 60% (> 50% si se debe a la implicación ósea del mieloma).
    8. El paciente es capaz de recibir anticoagulantes de forma profiláctica (los pacientes intolerantes a la aspirina podrán utilizar warfarina, acenocumarol o heparina de bajo peso molecular).
    9. Si la paciente es una mujer con Capacidad de Gestación (MCG), deberá tener una prueba de embarazo negativa en suero o en orina, con una sensibilidad de al menos 25 mUI/mL, realizada en los 10-14 días anteriores, y otra vez durante las 24 horas previas al inicio del tratamiento con lenalidomida, y tendrá que comprometerse, bien a abstenerse de mantener relaciones heterosexuales, o a comenzar a utilizar DOS métodos aceptados de control de natalidad, uno muy eficaz y otro adicional eficaz AL MISMO TIEMPO, al menos 28 días antes de comenzar el tratamiento con lenalidomida. Las MCG también tendrán que consentir a continuar con la realización de las pruebas de embarazo durante el tratamiento. Los varones tendrán que estar de acuerdo en utilizar preservativos de látex durante el contacto sexual con MCG incluso aunque se hayan sometido con éxito a una vasectomía.
    10. El paciente tiene una esperanza de vida ? 3 meses.
    11. Los pacientes deberán cumplir los siguientes parámetros de laboratorio:
    - Recuento absoluto de Neutrófilos (RAN) ? 1.0 x 10^9/L.
    - Hemoglobina ? 7 g/dL.
    - Recuento de plaquetas ? 75.000/mm3 ( > 30 x 10^9/L si hay gran infiltración de la médula ósea).
    - SGOT/AST en suero < 3.0 x límite superior de la normalidad (LSN).
    - SGPT/ALT en suero < 3.0 x límite superior de la normalidad (LSN).
    - Bilirrubina total en suero < 2.0 mg/dL (34 µmol/L).
    - Aclaramiento de creatinina ? 45 cc/min.
    E.4Principal exclusion criteria
    1. Subject has immeasurable MM (no measurable monoclonal protein, free light chains in blood or urine, or measureable plasmacytoma on radiologic scanning)
    2. Subject has a prior history of other malignancies unless disease-free for ? 5 years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or localized prostate cancer with Gleason score < 7 with stable prostate specific antigen (PSA) levels
    3. Subject has had myocardial infarction within 6 months prior to enrollment, or NYHA (New York Hospital Association) Class III or IV heart failure (see Appendix VI), Ejection Fraction < 35%, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, evidence of prolonged QTc interval in pre-treatment electrocardiogram, or active conduction system abnormalities
    4. Female subject who is pregnant or lactating
    5. Subject has known HIV infection
    6. Subject has known active hepatitis B or hepatitis C infection
    7. Subject has active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program
    8. Subject is unable to reliably take oral medications
    9. Subject has known hypersensitivity to dexamethasone, clarithromycin, lenalidomide, or thalidomide
    10. Subject has a history of thromboembolic event within the past 4 weeks prior to enrollment
    11. Subject has any clinically significant medical or psychiatric disease or condition that, in the investigator?s opinion, may interfere with protocol adherence or a subject?s ability to give informed consent
    12. Subject has previously been treated for MM
    1. El paciente tiene un MM con enfermedad no medible (proteína monoclonal o cadenas ligeras libres en sangre u orina no medibles, o plasmocitoma no medible en una exploración radiológica).
    2. El paciente tiene historial previo de otras neoplasias, a no ser que haya estado libre de enfermedad durante ? 5 años, excepto para casos de carcinoma basocelular o de células escamosas de la piel, carcinoma in situ de cérvix o de mama, o cáncer localizado de próstata con una puntuación de Gleason < 7, con niveles estables de PSA.
    3. El paciente tuvo un infarto de miocardio en los 6 meses previos a su inclusión, o una insuficiencia cardiaca de clase III o IV de la NYHA (véase Anexo VI), una fracción de eyección < 35%, angina incontrolada, arritmias ventriculares graves no controladas, evidencias electrocardiográficas de isquemia aguda, evidencia de intervalo QTc prolongado en electrocardiograma de pretratamiento o anormalidades activas del sistema de conducción.
    4. Mujer embarazada o en período de lactancia.
    5. Paciente con infección conocida por VIH.
    6. Paciente con infección activa por hepatitis B o hepatitis C.
    7. El paciente presenta infecciones bacterianas o virales activas, o cualquier problema médico coexistente que aumentaría significativamente los riesgos de recibir este esquema de tratamiento.
    8. El paciente es incapaz de tomar de forma fiable medicaciones orales.
    9. El paciente tiene hipersensibilidad conocida a dexametasona, claritromicina, lenalidomida o talidomida.
    10. El paciente tiene antecedentes de acontecimientos tromboembólicos en las últimas 4 semanas antes de su inclusión.
    11. El paciente tiene cualquier enfermedad médica o psiquiátrica significativa o estado que, en opinión del investigador, pueda interferir en el cumplimiento del protocolo o en la capacidad del paciente para dar su consentimiento informado.
    12. El paciente ya fue tratado anteriormente de MM.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-Free Survival (PFS).
    Supervivencia Libre de Progresión (SLP).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the study.
    Al final del estudio.
    E.5.2Secondary end point(s)
    1. Response rate by IMWG criteria.
    2. Event free survival (EFS) (an event is defined by coming off protocol for any reason, including progression of disease, lack of disease response, regimen intolerability, or death).
    3. Overall survival (OS).
    4. Duration of response (DOR).
    5. Time-To Progression (TTP).
    6. PFS 2: time from study entry until 2nd instance of disease progression.
    7. Quality of life: as measured by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT Fatigue) Scale as part of a quality of life assessment.
    8. Regimen toxicities, as defined by CTCAE V4.0.
    1. Tasa de respuesta según los criterios del Grupo de Trabajo Internacional del Mieloma (IMWG, por sus siglas en inglés).
    2. Supervivencia Libre de Evento (SLE) (un evento se define por la salida del estudio por cualquier motivo, incluyendo la progresión de la enfermedad, falta de respuesta al tratamiento, intolerancia a la medicación del estudio o muerte).
    3. Supervivencia Global (SG).
    4. Duración de la Respuesta (DDR).
    5. Tiempo Hasta Progresión (THP).
    6. SLP 2: tiempo desde el inicio del estudio hasta la documentación de la segunda progresión de la enfermedad.
    7. Calidad de vida: medida mediante la Escala de Evaluación Funcional para el Tratamiento de Enfermedades Crónicas - Fatiga (Escala FACIT Fatigue), como parte de un cuestionario sobre calidad de vida.
    8. Toxicidad de ambos regímenes de tratamiento, tal y como se define en el CTCAE V4.0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study.
    Al final del estudio.
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 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 concerned20
    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 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
    Spain
    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
    Last patient's last visit.
    Última visita del último paciente.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 306
    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 state153
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 153
    F.4.2.2In the whole clinical trial 306
    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 treatment.
    Tratamiento habitual.
    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 Decision2015-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-02
    P. End of Trial
    P.End of Trial StatusOngoing
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