Last updated on December 2016

Trial Studying Maintenance Treatment With Lenalidomide and Dexamethasone Versus Lenalidomide Dexamethasone and MLN9708 After Autologous Hematopoietic Stem Cell Transplantation in Patients With Newly-diagnosed Symptomatic Multiple Myeloma


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Multiple Myeloma
  • Age: Between 18 - 67 Years
  • Gender: Male or Female
  • Other:
    The patient must, in the opinion of the investigator, be capable of complying with
    all requirements of the trial.
    Have signed the informed consent form
    Be between 18 and 67 years of age
    Have an ECOG Performance Status <= 2 (or 3 if the ECOG is due to myeloma, e.g.
    pathological fracture)
    Multiple myeloma patient who was included in the GEM2012MENOS65 trial, and who is
    found to have, at a minimum, minimal response after consolidation
    Life expectancy > 3 months
    The patient must have the following laboratory values in the 21 days prior to
    initiation of treatment (day 1, cycle 1):
    Platelet count ≥ 100 x 109/L and absolute neutrophil count of ≥ 1.0 x 109/L. -
    Platelet transfusions to help patients meet eligibility criteria are not
    allowed.
    Corrected serum calcium < 14 mg/dL.
    Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x the upper
    limit of normal (ULN)
    Total bilirubin within normal range
    Calculated creatinine clearance > 30 mL/min
    Female patients who:
    Are postmenopausal for at least 1 year before the screening visit, OR
    Are surgically sterile, OR
    If they are of childbearing potential, agree to practice 2 effective methods of
    contraception, at the same time, from the time of signing the informed consent
    form through 90 days after the last dose of study drug, AND
    Must also adhere to the guidelines of any treatment-specific pregnancy
    prevention program, if applicable, OR
    Agree to practice true abstinence when this is in line with the preferred and
    usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation,
    ymptothermal, post-ovulation methods] and withdrawal are not acceptable methods
    of contraception.)
    Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree
    to one of the following:
    Agree to practice effective barrier contraception during the entire study
    treatment period and through 90 days after the last dose of study drug, OR
    Must also adhere to the guidelines of any treatment-specific pregnancy
    prevention program, if applicable, OR 30 Agree to practice true abstinence when
    this is in line with the preferred and usual lifestyle of the subject. (Periodic
    abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and
    withdrawal are not acceptable methods of contraception.)

You may not be eligible for this study if the following are true:

  • Patients not included in clinical trial GEM2012MENOS65
    Patients included in GEM2012MENOS65 who are not found to have a least minimal
    response after consolidation
    Patients included in GEM2012MENOS65 who were discontinued prematurely due to toxicity
    or disease progression
    Female patients who are lactating or have a positive serum pregnancy test during the
    creening period.
    Central nervous system involvement
    Infection requiring systemic antibiotic therapy or other serious infection within 14
    days before study enrollment.
    Systemic treatment, within 14 days before the first dose of MLN9708, with strong
    inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of
    CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole,
    nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin,
    carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort.
    Any serious medical or psychiatric illness that could, in the investigator's opinion,
    potentially interfere with the completion of treatment according to this protocol.
    Known GI disease or GI procedure that could interfere with the oral absorption or
    tolerance of MLN9708 including difficulty swallowing.
    Diagnosed or treated for another malignancy within 2 years before study enrollment or
    previously diagnosed with another malignancy and have any evidence of residual
    disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are
    not excluded if they have undergone complete resection.
    Peripheral neuropathy ≥ grade 2 in the 21 days prior to inclusion.
    Known hypersensitivity to lenalidomide or to MLN9708, their analogues, or excipients
    in the various formulations of any agent.
    Patients who have had a myocardial infarction in the six months prior to inclusion in
    the clinical trial, or who are class III or IV according to the New York Heart
    Association (NYHA), heart failure unstable angina, uncontrolled ventricular
    arrhythmias or acute ischemia detected by electrocardiogram, or conduction disorders.
    Patients who are currently participating in another clinical trial or receiving any
    other investigational product.
    Seropositive for HVB, HVC or HIV.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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