UARK 2014-21 A Phase II Trial of Oncolytic Virotherapy by Systemic Administration of Edmonston Strain of Measles Virus
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ClinicalTrials.gov Identifier: NCT02192775 |
Recruitment Status :
Completed
First Posted : July 17, 2014
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma | Drug: MV-NIS | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | March 2015 |
Actual Primary Completion Date : | August 20, 2019 |
Actual Study Completion Date : | August 20, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: MV-NIS + Cyclophosphamide |
Drug: MV-NIS
one dose in conjunction with a 4 day course intravenously
Other Name: Recombinant Edmonston measles virus with human NIS gene |
- The Effectiveness of MV-NIS Therapy as Measured by the International Myeloma Working Group (IMWG) Guidelines [ Time Frame: 1 year ]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

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192775
United States, Arkansas | |
University of Arkansas for Medical Science | |
Little Rock, Arkansas, United States, 72205 |
Principal Investigator: | Frits Van Rhee, MD, Ph.D | University of Arkansas |
Documents provided by University of Arkansas:
Responsible Party: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT02192775 |
Other Study ID Numbers: |
203081 |
First Posted: | July 17, 2014 Key Record Dates |
Results First Posted: | October 19, 2020 |
Last Update Posted: | October 19, 2020 |
Last Verified: | September 2020 |
Measles virus Sodium Iodide Symporter Cyclophosphamide Refractory multiple myeloma |
Measles Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases |
Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Morbillivirus Infections Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections Virus Diseases Infections |