ClinicalTrials.gg
CompletedNCT02192775Updated Oct 19, 2020Results posted

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

A Phase 2 interventional study of MV-NIS in Multiple Myeloma, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by University of Arkansas · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 55 studies in Multiple Myeloma by University of Arkansas — 1 open to participants now, 5 under way, 2 of them phase 3. Multiple Myeloma · University of Arkansas.

Enrollment
40th of 48
2 · median 20
Started
2015
with 3 others
Phase 2
27 of 55
1 open now
Registered
48th of 55
by date

Among the 55 studies in Multiple Myeloma by University of Arkansas, this one is the 40th largest by enrollment of the 48 interventional ones that give a count, is one of 4 that started in 2015, is one of 27 in phase 2, and was the 48th registered.

Multiple Myeloma

3,763 studies on the registry are indexed under Multiple Myeloma; 772 are open to participants now.

Browse Multiple Myeloma studies →

Open to participants now

1 of the 55 studies in Multiple Myeloma by University of Arkansas is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 585 Multiple Myeloma studies recruiting now, 430 (74%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 55 studies in Multiple Myeloma by University of Arkansas, or all of them as a file.
02

Study 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

Read the 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.

03

Conditions studied

  • Multiple Myeloma

Browse trials for

Keywords

  • Measles virus
  • Sodium Iodide Symporter
  • Cyclophosphamide
  • Refractory multiple myeloma
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 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 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 (, 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 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

Exclusion Criteria:

  • Patients may not be positive for the (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 , 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 exceeds three years as determined by the PI
  • Pregnant or nursing women may not participate. Women of must have a negative pregnancy test documented within one week of registration. Women/men of may not participate unless they have agreed to use an effective method
  • Exposure to household contacts ≤ 15 months old or household contact with known immunodeficiency
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    MV-NIS + Cyclophosphamide

    Drug: MV-NIS

Interventions

  • DrugMV-NIS

    one dose in conjunction with a 4 day course intravenously

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

06

What researchers measure

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

    Time frame: 1 year

07

Results

Posted Oct 19, 2020

Participant flow

Participant flow — Overall Study
MilestoneMV-NIS + Cyclophosphamide
Started2
Completed0
Not completed2

Outcome measures

PrimaryThe 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

Time frame:
1 year

No measurements were reported for this outcome.

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MV-NIS + Cyclophosphamide2/2 (100%)2/2 (100%)2/2 (100%)
Most frequent serious events
Most frequent serious events
EventMV-NIS + Cyclophosphamide
HyperammoniaMetabolism and nutrition disorders1/2
HypercalcemiaMetabolism and nutrition disorders1/2
Decreased Respiratory RateRespiratory, thoracic and mediastinal disorders1/2
ApneaRespiratory, thoracic and mediastinal disorders1/2
Pleural EffusionRespiratory, thoracic and mediastinal disorders1/2
Acidosis (Metabolic)Metabolism and nutrition disorders1/2
Alterned Mental StateNervous system disorders1/2
HypoxiaRespiratory, thoracic and mediastinal disorders1/2
SepsisInfections and infestations1/2
Respiratory FailureRespiratory, thoracic and mediastinal disorders1/2
Most frequent other events
Showing 10 of 18
Most frequent other events
EventMV-NIS + Cyclophosphamide
Neutrophil Count DecreasedInvestigations2/2
C-Reactive Protein IncreasedInvestigations2/2
HypokalemiaMetabolism and nutrition disorders2/2
Sinus TachycardiaCardiac disorders1/2
Localized EdemaGeneral disorders1/2
Lactate IncreasedInvestigations1/2
Lactate Dehydrogenase IncreasedInvestigations1/2
HyperglycemiaMetabolism and nutrition disorders1/2
HypernatremiaMetabolism and nutrition disorders1/2
HyperphosphatemiaMetabolism and nutrition disorders1/2

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)MV-NIS + Cyclophosphamide
<=18 years0
Between 18 and 65 years1
>=65 years1
Sex: Female, Male
Sex: Female, Male(Participants)MV-NIS + Cyclophosphamide
Female1
Male1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)MV-NIS + Cyclophosphamide
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White2
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)MV-NIS + Cyclophosphamide
United States2
08

Study locations

1 site
  • University of Arkansas for Medical Science
    Little Rock, Arkansas 72205, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2015 to primary completion in Aug 2019, 53 months.

Results were first posted in Oct 2020, 1 year 1 month after primary completion.

Of 412 non-industry phase 2 interventional studies under Multiple Myeloma, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 96. This study's 53 months is below that.

Counting every sponsor, half of 505 studies reached it within 57 months; a quarter within 35 and three quarters within 95.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 2, 2014
First posted
Jul 17, 2014
StartActual
Mar 2015
Primary completionActual
Aug 20, 2019
CompletionActual
Aug 20, 2019
Results first posted
Oct 19, 2020
Last update
Oct 19, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02192775
Responsible party
Sponsor
First posted
Jul 17, 2014
Start date
Mar 2015
Primary completion
Aug 20, 2019
Completion
Aug 20, 2019
Results posted
Oct 19, 2020
Last update
Oct 19, 2020

Study contacts

Frits Van Rhee, MD, Ph.D
principal investigator · University of Arkansas

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter

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