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A Phase II Study of Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma (NCT03030261)

Bristol-Myers Squibb
Based on the need to improve outcomes post second autologous stem cell transplant (ASCT) for multiple myeloma (MM) and the benefits seen of maintenance treatment following initial ASCT, the natural next step is to evaluate maintenance/continuation therapy following second ASCT. Pomalidomide is active against MM cells refractory to both bortezomib and lenalidomide, making it an ideal choice for continuation therapy following second ASCT. Adding elotuzumab may increase efficacy and also the durability of responses which is essential to improving outcomes following second ASCT.
  • Drug: Elotuzumab
    During induction therapy, elotuzumab will be administered on a 28-day cycle as follows: on Days 1, 8, 15, and 22 for Cycles 1-2 and Days 1 and 15 for Cycles 3-4. Elotuzumab will be administered intravenously at a dose of 10 mg/kg. During continuation therapy, elotuzumab will be administered on a 28-day cycle as follows: on Days 1 and 15 for Cycles 1-6 and on Day 1 for Cycles 7+. For Cycles 1-6 elotuzumab will be administered intravenously at a dose of 10 mg/kg. For Cycles 7+ elotuzumab will be administered at a dose of 20 mg/kg.
    • Empliciti
  • Drug: Pomalidomide
    During induction therapy, pomalidomide will be taken by mouth daily on Days 1-21 of each 28-day cycle at a starting dose of 4 mg. During continuation therapy, pomalidomide will be taken by mouth daily on Days 1-21 of each 28-day cycle at a starting dose of 2 mg. During continuation, pomalidomide may be dose escalated to 4 mg at the discretion of the treating physician if the 2 mg dose is tolerated.
    • Pomalyst
  • Drug: Dexamethasone
    During induction, dexamethasone will be taken by mouth on Days 1, 8, and 15 of each of four 28-day cycles at a starting dose of 40 mg. During continuation therapy, dexamethasone will be taken by mouth at a starting dose of 40 mg. It will be given on a 28-day cycle as follows: on Days 1 and 15 for Cycles 1-6 and on Day 1 only for Cycles 7+. Sufficient quantity of drug for one cycle of therapy will be prescribed to the patient at a time.
    • Decadron
  • Procedure: Autologous stem cell transplant
    -Standard of care
    • ASCT
  • Drug: Melphalan
    -Standard of care
    Ages eligible for Study
    18 Years to 75 Years
    Genders eligible for Study
    Accepts Healthy Volunteers
    Inclusion Criteria:
    • Histologically confirmed diagnosis of multiple myeloma.
    • Received prior autologous stem cell transplantation as first line therapy for multiple myeloma with subsequent disease relapse/progression.
    • Refractory to or intolerant of lenalidomide maintenance following first autologous stem cell transplantation. Refractory is defined as disease relapse/progression on therapy or within 60 days of completing therapy. Intolerance is defined as the inability to administer ≥ 10 mg per day due to toxicity.
    • All study participants must be registered into the mandatory POMALYST REMS® program and be willing and able to comply with the requirements of the POMALYST REMS® program.
    • Females of reproductive potential must agree to adhere to the scheduled pregnancy testing as required in the POMALYST REMS® program.
    • Candidate for second autologous stem cell transplantation per local institution's guidelines with at least 2x106/kg CD34+ autologous stem cells available for transplantation.
    • At least 18 and no more than 75 years of age at enrollment.
    • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
    • Normal bone marrow and organ function as defined as ALL of the following:
    • Absolute neutrophil count ≥ 1000/mm^3
    • Platelets ≥ 75,000/mm^3 (transfusions not permitted within 7 days of screening)
    • Total bilirubin ≤ 2.0 x institutional upper limit of normal (IULN)
    • AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
    • Creatinine clearance ≥ 15 mL/min
    • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry through Day +100 visit. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
    • Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document.
    Exclusion Criteria:
    • Prior exposure to elotuzumab or pomalidomide.
    • Received systemic multiple myeloma therapy post-relapse/progression. Patients that received 1-2 cycles of salvage therapy, local radiation, and/or corticosteroids post-relapse/progression are eligible if there was no further disease progression following administration.
    • More than one prior transplant prior to study entry with the exception of tandem transplantation. Tandem transplantation is defined as two autologous stem cell transplants that occur within 9 months of one another, and the patient did not have disease progression in the period between the two transplants.
    • Presence of peripheral neuropathy ≥ grade 3 based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.0
    • History of plasma cell leukemia or MM central nervous system (CNS) involvement.
    • Receiving renal replacement therapy, hemodialysis, or peritoneal dialysis.
    • Diagnosed with another concurrent malignancy requiring treatment.
    • Known HIV or active hepatitis A, B, or C.
    • Known hypersensitivity to pomalidomide, dexamethasone, or any excipients in elotuzumab, formulation, or recombinant protein
    • Receiving any other investigational agents within 14 days prior to enrollment.
    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
    • Pregnant and/or breastfeeding. Women of childbearing potential must have two negative pregnancy tests. The first test should be performed within 10-14 days of study entry, and the second test within 24 hours prior to prescribing pomalidomide.

    1 locations

    United States (1)
    • Washington University School of Medicine
      Saint Louis, Missouri, United States, 63110
    21 November, 2017
    30 November, 2017
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