UARK 2014-21 A Phase II Trial of Oncolytic Virotherapy by Systemic Administration of Edmonston Strain of Measles Virus
Condition: Multiple Myeloma
MeSH terms: Measles; Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: MV-NIS
Intervention description: one dose in conjunction with a 4 day course intravenously
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Measles virus; Sodium Iodide Symporter; Cyclophosphamide; Refractory multiple myeloma

Summary:

      The purpose of this study is to determine the clinical efficacy of MV-NIS (measles
      virus-sodium iodide symporter) therapy for people with relapsed/refractory myeloma when given
      with cyclophosphamide
    

Eligibility criteria:

        Inclusion Criteria:

          -  Relapsed patients must have a confirmed MM diagnosis with high-risk disease as defined
             by GEP70 risk score ≥ 0.66 or GEP80 gene score of ≥ 2.48 or metaphase cytogenetic
             abnormalities or LDH ≥ 360 U/L due to MM (Rule out hemolysis, infection and contact PI
             for clarification if any doubt). Patients must have relapsed after auto-PBSCT followed
             by further chemotherapy

          -  ≥2 months must have elapsed after the last peripheral blood stem cell transplant prior
             to enrollment

          -  Zubrod ≤ 2, unless solely due to symptoms of MM-related (bone) disease

          -  Patients must have a platelet count of ≥ 20,000/µL within 45 days of registration,
             unless lower levels are explained by extensive BM plasmacytosis or extensive prior
             therapy

          -  Patients must be at least 18 years of age and not older than 75 years of age at the
             time of registration

          -  Participants must have preserved renal function as defined by a serum creatinine level
             of ≤ 3 mg/dL within 45 days of registration

          -  Participants must have an ejection fraction by ECHO or MUGA scan ≥ 40% within 45 days
             prior to registration

          -  Patients must have adequate pulmonary function studies > 50% of predicted on
             mechanical aspects (FEV1, etc) and diffusion capacity (DLCO) > 50% of predicted within
             45 days prior to registration. If the patient is unable to complete pulmonary function
             tests due to MM related pain or condition, exception may be granted

          -  Patients must have signed an IRB-approved informed consent and Health Insurance
             Portability and Accountability Act (HIPAA) authorization form

          -  Patients must have anti-MV IgG titer of ≤ 0.5U/mL (Mayo clinic assay). Mayo Clinic
             will also assay the patients' IgM titer and perform a neutralizing antibody
             plaque-assay to determine recent MV exposure and the ability of the patients'
             circulating antibodies to inhibit MV propagation on Vero cells, respectively. While
             these tests are additional indicators of patient eligibility, final enrollment
             decision will be determined by IgG levels

        Exclusion Criteria:

          -  Patients may not be positive for the Human Immunodeficiency Virus (HIV)

          -  History of poorly controlled hypertension, diabetes mellitus, or any other serious
             medical illness or psychiatric illness that could potentially interfere with the
             completion of treatment according to this protocol or could be considered to be an
             exclusion criterion deemed by the PI

          -  Patients must not have prior malignancy, except for adequately treated basal cell or
             squamous cell skin cancer, in situ cervical cancer, or other cancer for which the
             patient has not received treatment for one year prior to enrollment. Other cancers
             will only be acceptable if the patient's life expectancy exceeds three years as
             determined by the PI

          -  Pregnant or nursing women may not participate. Women of childbearing potential must
             have a negative pregnancy test documented within one week of registration. Women/men
             of reproductive potential may not participate unless they have agreed to use an
             effective contraceptive method

          -  Exposure to household contacts ≤ 15 months old or household contact with known
             immunodeficiency