Trial Outcomes & Findings for UARK 2014-21 A Phase II Trial of Oncolytic Virotherapy by Systemic Administration of Edmonston Strain of Measles Virus (NCT NCT02192775)
NCT ID: NCT02192775
Last Updated: 2020-10-19
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
1 year
Results posted on
2020-10-19
Participant Flow
Participant milestones
| Measure |
MV-NIS + Cyclophosphamide
MV-NIS: one dose in conjunction with a 4 day course intravenously
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
UARK 2014-21 A Phase II Trial of Oncolytic Virotherapy by Systemic Administration of Edmonston Strain of Measles Virus
Baseline characteristics by cohort
| Measure |
MV-NIS + Cyclophosphamide
n=2 Participants
MV-NIS: one dose in conjunction with a 4 day course intravenously
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Only two subjects were enrolled. Both passed away while enrolled. No data were collected.
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
Outcome measures
Outcome data not reported
Adverse Events
MV-NIS + Cyclophosphamide
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
MV-NIS + Cyclophosphamide
n=2 participants at risk
MV-NIS: one dose in conjunction with a 4 day course intravenously
|
|---|---|
|
Metabolism and nutrition disorders
Hyperammonia
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Decreased Respiratory Rate
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Acidosis (Metabolic)
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Nervous system disorders
Alterned Mental State
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
50.0%
1/2 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
MV-NIS + Cyclophosphamide
n=2 participants at risk
MV-NIS: one dose in conjunction with a 4 day course intravenously
|
|---|---|
|
Cardiac disorders
Sinus Tachycardia
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
General disorders
Localized Edema
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Investigations
Neutrophil Count Decreased
|
100.0%
2/2 • Number of events 3 • 1 year
|
|
Investigations
C-Reactive Protein Increased
|
100.0%
2/2 • Number of events 2 • 1 year
|
|
Investigations
Lactate Increased
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Investigations
Lactate Dehydrogenase Increased
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypernatremia
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
100.0%
2/2 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Infections and infestations
Enterocolitis Infectious
|
50.0%
1/2 • Number of events 1 • 1 year
|
|
Investigations
Lymphocyte Count Decreased
|
50.0%
1/2 • Number of events 2 • 1 year
|
|
Investigations
White Blood Count Decreased
|
50.0%
1/2 • Number of events 2 • 1 year
|
Additional Information
Brittany Lehman
University of Arkansas for Medical Sciences
Phone: 501-686-8274
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place