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UARK 2014-21 A Phase II Trial of Oncolytic Virotherapy by Systemic Administration of Edmonston Strain of Measles Virus

NCT02192775

Description:

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

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: UARK 2014-21 A Phase II Trial of Oncolytic Virotherapy by Systemic Administration of Edmonston Strain of Measles Virus
  • Official Title: A Phase II Trial of Oncolytic Virotherapy by Systemic Administration of Edmonston Strain of Measles Virus, Genetically Engineered to Express NIS, With Cyclophosphamide, in Patients With Recurrent of Refractory Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: 203081
  • NCT ID: NCT02192775

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
MV-NISRecombinant Edmonston measles virus with human NIS geneMV-NIS + Cyclophosphamide

Purpose

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

Detailed Description

      The drug used in this trial is a modified version of the measles virus used to vaccinate
      children. The virus has been altered by having an extra gene (piece of DNA) added to it to
      allow a protein called NIS to be inserted into it. NIS is normally found in the thyroid gland
      ( a small gland in the neck) and helps the body concentrate iodine. Having this additional
      gene will make it possible to track where the virus goes in the body.
    

Trial Arms

NameTypeDescriptionInterventions
MV-NIS + CyclophosphamideExperimental
  • MV-NIS

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
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The effectiveness of MV-NIS therapy as measured by the International Myeloma Working Group (IMWG) guidelines
Time Frame:1 year
Safety Issue:
Description:The primary objective of this study is to assess the effectiveness of MV-NIS therapy for people with relapsed/refractory myeloma when given with cyclophosphamide

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Arkansas

Trial Keywords

  • Measles virus
  • Sodium Iodide Symporter
  • Cyclophosphamide
  • Refractory multiple myeloma

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