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    Summary
    EudraCT Number:2007-007756-34
    Sponsor's Protocol Code Number:CC-5013-MCL-001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-26
    Trial results View 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 number2007-007756-34
    A.3Full title of the trial
    A Phase 2, multicenter, single-arm, open-label study to determine the efficacy and safety of single-agent lenalidomide (Revlimid ®) in patients with mantle cell NHL who have relapsed or progressed after treatment with Bortezomib or are refractory to Bortezomib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of lenalidomide in the treatment of patients with mantle cell
    non-Hodgkin's lymphoma, whose disease has returned after the disease completely disappeared or almost completely disappeared following treatment with bortezomib or patients whose disease does not respond and may even worsen after treatment with bortezomib.
    A.3.2Name or abbreviated title of the trial where available
    the Emerge trial
    A.4.1Sponsor's protocol code numberCC-5013-MCL-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00737529
    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 SponsorCelgene Corporation
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9225 Indian Creek Parkway, Suite 900
    B.5.3.2Town/ cityKansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1-888-260-1599
    B.5.5Fax number+1 913-266-0394
    B.5.6E-mailClinicalTrialDisclosure@celgene.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 25mg, hard capsules
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule
    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.3.9.2Current sponsor codeCC-5013
    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: 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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLenalidomide
    D.3.2Product code CC-5013
    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.3.9.2Current sponsor codeCC-5013
    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: 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, hard capsules
    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 No
    D.2.5.1Orphan drug designation number
    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.3.9.2Current sponsor codeCC-5013
    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 10mg, hard capsules
    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 No
    D.2.5.1Orphan drug designation number
    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.3.9.2Current sponsor codeCC-5013
    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: 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 5mg, hard capsules
    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 No
    D.2.5.1Orphan drug designation number
    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.3.9.2Current sponsor codeCC-5013
    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: 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 2.5mg, hard capsule
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLenalidomide
    D.3.2Product code CC-5013
    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.3.9.2Current sponsor codeCC-5013
    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 number2.5
    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
    Mantle cell lymphoma
    E.1.1.1Medical condition in easily understood language
    Cancer affecting a sub-type of lymphocytes B (protect the body againstinfections) that don't mature properly and multiply abnormally in the lymph nodes (mantle zone)
    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 HLT
    E.1.2Classification code 10026798
    E.1.2Term Mantle cell lymphomas
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the tumor response and duration of response of lenalidomide monotherapy in patients with mantle cell lymphoma (MCL) who have relapsed or progressed after treatment with bortezomib or are refractory to bortezomib (Cheson, 1999)
    E.2.2Secondary objectives of the trial
    •To evaluate the safety of lenalidomide monotherapy in patients with
    MCL who have relapsed or progressed after treatment with bortezomib
    or are refractory to bortezomib
    •To determine the CR, time to progression, time to treatment failure,
    progression-free survival and overall survival of lenalidomide
    monotherapy in patients with MCL who have relapsed or progressed
    after treatment with bortezomib or are refractory to bortezomib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must understand and voluntarily sign an informed consent form.

    2. Must be ≥ 18 years of age at the time of signing the informed consent form.

    3. Must be able to adhere to the study visit schedule and other protocol requirements.

    4. Biopsy-proven mantle cell NHL, including overexpression of cyclin D1 by immunohistochemistry or t(11;14)(q13;q32) by FISH. In patients
    whose tumors are negative for the cyclin D1 overexpression or
    translocation, overexpression of cyclin D2 or D3 by
    immunohistochemistry will be acceptable.

    5. Must have received all of the following agents (alone or in combination). (There is no limit on the number of agents or prior
    therapies). The following agents can be given in any combination:
    - Anthracycline or mitoxantrone
    - Cyclophosphamide
    - Rituximab
    -Bortezomib

    6. Patients must have documented relapsed, refractory or PD after
    treatment with bortezomib (or a bortezomib containing regimen) based
    on the following definitions:
    - Relapsed lymphoma: patients with relapse within one year of last
    dose of bortezomib (or a bortezomib containing regimen) following
    initial response of CR to bortezomib (or a bortezomib containing
    regimen)
    - Lymphoma refractory to bortezomib: patients with PD without any
    documented response of PR or better during treatment with bortezomib (or a bortezomib containing regimen) and having received at least 2 cycles of bortezomib (or a bortezomib containing regimen)
    - Progressive disease: patients with PD within one year of last dose of
    bortezomib (or bortezomib containing regimen) following initial
    response of PR to bortezomib (or a bortezomib containing regimen)

    7. Patients who have relapsed following high dose
    chemotherapy/autologous stem cell transplant are eligible.

    8. Must have measurable disease on cross sectional imaging by CT that
    is at least 2 cm in the longest diameter and measurable in two
    perpendicular dimensions.

    9. Eastern Cooperative Oncology Group (ECOG) performance status
    score of 0, 1, or 2.

    10. Life expectancy of ≥ 90 days (3 months).

    11. Females of child-bearing potential (FCBP) must agree to:
    -Have two medically supervised pregnancy tests prior to starting of
    study therapy. The first pregnancy test will be performed within 10-14
    days prior to the start of lenalidomide and the second pregnancy test
    will be performed within 24 hours prior to the start of lenalidomide. She
    must also agree to ongoing pregnancy testing during the course of the
    study, and after the end of study therapy. This applies even if the
    patient practices complete and continued sexual abstinence.
    -Either commit to continued abstinence from heterosexual intercourse
    (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28
    days prior to starting study drug, during the study therapy (including
    dose interruptions), and for 28 days after discontinuation of study
    therapy.

    12. Male patients must:
    -Agree to use a condom during sexual contact with a FCBP, even if they
    have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
    -Agree to not donate semen during study drug therapy and for a period after end of study drug therapy.

    13. All patients must:
    -Have an understanding that the study drug could have a potential
    teratogenic risk.
    - Agree to abstain from donating blood while taking study drug therapy
    and following discontinuation of study drug therapy.
    -Agree not to share study medication with another person.
    - Must be counseled about pregnancy precautions and risks of fetal
    exposure.
    E.4Principal exclusion criteria
    1. Diagnosis of lymphoma other than MCL.

    2. Transformed lymphoma

    3. Any of the following laboratory abnormalities.
    - Absolute neutrophil count (ANC) < 1,500 cells/mm^3 (1.5 x 10^9/L).
    - Platelet count < 60,000/mm^3 (60 x 10^9/L).
    - Serum aspartate transaminase (AST/SGOT) or alanine transaminase
    (ALT/SGPT) > 3.0 x upper limit of normal (ULN), except in patients with
    documented liver involvement by lymphoma
    - Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert's Syndrome and documented liver involvement by lymphoma.

    4. Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL
    /min

    5. Active central nervous system (CNS) lymphoma with the exception of
    those patients whose CNS lymphoma has been treated with
    chemotherapy, radiotherapy or surgery, have remained asymptomatic
    for 90 days (3 months) and demonstrate no CNS lymphoma as shown by lumbar puncture, CT are eligible. Patients with a history of CNS
    involvement or CNS symptoms will be required to have negative
    cerebrospinal fluid (CSF) cytology examination and a head CT during the screening period

    6. Patients who are candidates for high dose chemotherapy/autologous
    or allogeneic stem cell transplant at the time of enrollment are not
    eligible. Provided the determination is clearly documented in the patient's source document, the patient is eligible if:
    - the physician indicates that the patient is not appropriate for
    autologous or allogeneic transplant at the time of enrollment, or
    - the patient has refused high dose chemotherapy/autologous or
    allogeneic transplant

    7. Patients who have relapsed following allogeneic stem cell transplant
    and who have persistent donor hematopoiesis are not eligible

    8. Patients should not be receiving corticosteroids except for prednisone ≤ 10 mg/day or equivalent for purposes other than treating MCL.

    9. Patients not willing to take DVT prophylaxis.

    10. Prior history of malignancies, other than MCL, unless the patient has been free of the disease for ≥ 5 years. Exceptions include the following:
    - Basal cell carcinoma of the skin
    - Squamous cell carcinoma of the skin
    - Carcinoma in situ of the cervix
    - Carcinoma in situ of the breast
    - Incidental histological finding of prostate cancer (TNM stage of T1a or
    T1b)

    11. Known seropositive for or active viral infection with human
    immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C
    virus (HCV). Patients who are seropositive because of hepatitis B virus
    vaccine are eligible.

    12. Uncontrolled intercurrent illness including, but not limited to:
    - Ongoing or active infection requiring parenteral antibiotics
    - Uncontrolled diabetes mellitus
    - Chronic symptomatic congestive heart failure (Class III or IV of the
    New York Heart Association Classification for Heart Disease)
    - Unstable angina pectoris, angioplasty, stenting, or myocardial
    infarctions within 180 days (6 months)
    - Clinically significant cardiac arrhythmia that is symptomatic or requires
    treatment, or asymptomatic sustained ventricular tachycardia. Patients
    with controlled atrial fibrillation that is asymptomatic are eligible.

    13. Desquamating (blistering) rash while taking thalidomide

    14. This exclusion criterion was removed with Amendment #1

    15. Prior use of lenalidomide

    16. Use of the following prior to initiation (day 1 cycle 1) of study drug:
    - Prior chemotherapy within 2 weeks (with recovery of bone marrow
    function),
    - Nitrosoureas within 6 weeks
    - Antibody agents within 8 weeks
    - Radioimmunoconjugate within 12 weeks
    - Radiation therapy within 3 weeks (except for cranial RT and electron
    beam)

    17. Any serious medical condition, laboratory abnormality, or
    psychiatric illness that would prevent the patient from signing the
    informed consent form

    18. Pregnant or lactating females.

    19. Any condition, including the presence of laboratory abnormalities,
    which places the patient at unacceptable risk if he/she were to
    participate in the study or confounds the ability to interpret data from
    the study.

    20. Participation in another clinical trial during the pre-treatment and
    treatment phase of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Tumor response rate and duration of response (Radiological
    assessments as defined by the IWLRC 1999)
    E.5.1.1Timepoint(s) of evaluation of this end point
    • The primary analyses for response will be performed on the ITT and
    MITT populations after all patients' complete 6 cycles or progress before completing 6 cycles.
    • Duration of response will be analyzed at the time of the primary
    analysis of response, but the primary analysis of duration of response
    will be performed on the ITT and MITT populations after all patients
    enrolled in the study have completed at least one year or have dropped
    out before completing one year.
    E.5.2Secondary end point(s)
    • Complete response (CR)/Complete Response unconfirmed (Cru) and
    Duration of response
    • Progression–free survival (PFS)
    • Time to tumor progression (TTP)
    • Time to treatment failure (TTF)
    • Overall survival (OS)
    • Safety
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints will be analyzed at the time of the primary analysis of response. However, final analyses for PFS, TTP, TTF and OS will be performed after 100% of the patients have died are lost to follow up or have withdrawn consent or a maximum of 4 years from last patient enrolled, which ever comes first.
    Follow-up for second primary malignancies and OS will continue until 100% of the patients have died, are lost to follow up, have withdrawn consent, or a maximum of 5 years from the last patient enrolled, whichever comes first.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Chile
    Colombia
    Israel
    Singapore
    Turkey
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study will be terminated at the end of the follow up phase: until
    either 100% of the patients have died, are lost to follow up or have
    withdrawn consent or a maximum of 5 years from last patient enrolled
    (LPI), which ever comes first.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    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 years8
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 83
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 133
    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)
    Patients who discontinue due to any reason will be followed by clinic
    visit/documented telephone contact every 90days (+/- 14d) for
    survival, and subsequent antilymphoma therapies. The f.u will continue
    until 100% of patients have died, are lost to follow up or have
    withdrawn consent or 4 years from LPI, which ever comes first. At
    study closure provision of further treatment to patients still responding
    will be discussed in line with local regulations
    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 Decision2009-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-08
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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