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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
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Intervention Drug: MV-NIS
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MV-NIS + Cyclophosphamide
Hide Arm/Group Description MV-NIS: one dose in conjunction with a 4 day course intravenously
Period Title: Overall Study
Started 2
Completed 0
Not Completed 2
Arm/Group Title MV-NIS + Cyclophosphamide
Hide Arm/Group Description MV-NIS: one dose in conjunction with a 4 day course intravenously
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  50.0%
>=65 years
1
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
2
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title The Effectiveness of MV-NIS Therapy as Measured by the International Myeloma Working Group (IMWG) Guidelines
Hide 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
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Only two subjects were enrolled. Both passed away while enrolled. No data were collected.
Arm/Group Title MV-NIS + Cyclophosphamide
Hide Arm/Group Description:
MV-NIS: one dose in conjunction with a 4 day course intravenously
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MV-NIS + Cyclophosphamide
Hide Arm/Group Description MV-NIS: one dose in conjunction with a 4 day course intravenously
All-Cause Mortality
MV-NIS + Cyclophosphamide
Affected / at Risk (%)
Total   2/2 (100.00%)    
Hide Serious Adverse Events
MV-NIS + Cyclophosphamide
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Infections and infestations   
Sepsis   1/2 (50.00%)  1
Metabolism and nutrition disorders   
Hyperammonia   1/2 (50.00%)  1
Hypercalcemia   1/2 (50.00%)  1
Acidosis (Metabolic)   1/2 (50.00%)  1
Nervous system disorders   
Alterned Mental State   1/2 (50.00%)  1
Respiratory, thoracic and mediastinal disorders   
Decreased Respiratory Rate   1/2 (50.00%)  1
Apnea   1/2 (50.00%)  1
Pleural Effusion   1/2 (50.00%)  1
Hypoxia   1/2 (50.00%)  1
Respiratory Failure   1/2 (50.00%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MV-NIS + Cyclophosphamide
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Blood and lymphatic system disorders   
Anemia   1/2 (50.00%)  1
Cardiac disorders   
Sinus Tachycardia   1/2 (50.00%)  1
General disorders   
Localized Edema   1/2 (50.00%)  1
Infections and infestations   
Enterocolitis Infectious   1/2 (50.00%)  1
Investigations   
Neutrophil Count Decreased   2/2 (100.00%)  3
C-Reactive Protein Increased   2/2 (100.00%)  2
Lactate Increased   1/2 (50.00%)  1
Lactate Dehydrogenase Increased   1/2 (50.00%)  1
Lymphocyte Count Decreased   1/2 (50.00%)  2
White Blood Count Decreased   1/2 (50.00%)  2
Metabolism and nutrition disorders   
Hyperglycemia   1/2 (50.00%)  1
Hypernatremia   1/2 (50.00%)  1
Hyperphosphatemia   1/2 (50.00%)  1
Hypocalcemia   1/2 (50.00%)  1
Hypoglycemia   1/2 (50.00%)  1
Hypokalemia   2/2 (100.00%)  3
Musculoskeletal and connective tissue disorders   
Generalized Muscle Weakness   1/2 (50.00%)  1
Respiratory, thoracic and mediastinal disorders   
Wheezing   1/2 (50.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Brittany Lehman
Organization: University of Arkansas for Medical Sciences
Phone: 501-686-8274
EMail: blehman@uams.edu
Layout table for additonal information
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02192775    
Other Study ID Numbers: 203081
First Submitted: July 2, 2014
First Posted: July 17, 2014
Results First Submitted: August 27, 2020
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020