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

NCT02192775 | Completed Phase 2 Results DMC

• 1 other identifier: 203081
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Multiple Myeloma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The Effectiveness of MV-NIS Therapy as Measured by the International Myeloma Working Group (IMWG) Guidelines

  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

  1 year

Study Arms (1)

MV-NIS + Cyclophosphamide

EXPERIMENTAL

Drug: MV-NIS

Interventions

MV-NIS DRUG

one dose in conjunction with a 4 day course intravenously

Also known as: Recombinant Edmonston measles virus with human NIS gene

MV-NIS + Cyclophosphamide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients may not be positive for the Human Immunodeficiency Virus (HIV)
• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Science

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Brittany Lehman
• Organization: University of Arkansas for Medical Sciences

blehman@uams.edu

501-686-8274

Study Officials

• Frits Van Rhee, MD, Ph.D

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 17, 2014
• Study Start: March 1, 2015
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-09

Locations

US (1)