Trial Outcomes & Findings for UARK 2013-05 A Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma (NCT NCT01884688)
NCT ID: NCT01884688
Last Updated: 2017-04-17
Results Overview
Number of participants with at least 4 fold increase in absolute CD3-CD56+ NK cell count/uL blood 7 days after infusion over the pre-study baseline level
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
7 days
Results posted on
2017-04-17
Participant Flow
Participant milestones
| Measure |
ENK Cell Infusion
Expanded Natural Killer Cell Infusion
ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
ENK Cell Infusion
Expanded Natural Killer Cell Infusion
ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU
|
|---|---|
|
Overall Study
Screen Failure
|
2
|
Baseline Characteristics
UARK 2013-05 A Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma
Baseline characteristics by cohort
| Measure |
ENK Cell Infusion
n=1 Participants
Expanded Natural Killer Cell Infusion
ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU
|
|---|---|
|
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
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 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
|
1 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
|
PRIMARY outcome
Timeframe: 7 daysNumber of participants with at least 4 fold increase in absolute CD3-CD56+ NK cell count/uL blood 7 days after infusion over the pre-study baseline level
Outcome measures
| Measure |
ENK Cell Infusion
n=1 Participants
Expanded Natural Killer Cell Infusion
ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU
|
|---|---|
|
Increase in ENK (Expanded Natural Killer Cells) Cells 7 Days After Treatment
|
0 Participants
|
Adverse Events
ENK Cell Infusion
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ENK Cell Infusion
n=1 participants at risk
Expanded Natural Killer Cell Infusion
ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU
|
|---|---|
|
Blood and lymphatic system disorders
Grade 1 Anemia
|
100.0%
1/1
|
|
Blood and lymphatic system disorders
Grade 2 Anemia
|
100.0%
1/1
|
|
Musculoskeletal and connective tissue disorders
Grade 1 Arthritis
|
100.0%
1/1
|
|
Injury, poisoning and procedural complications
Grade 1 Bruising
|
100.0%
1/1
|
|
Eye disorders
Grade 1 Cataract
|
100.0%
1/1
|
|
Gastrointestinal disorders
Grade 1 Constipation
|
100.0%
1/1
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 Dyspnea
|
100.0%
1/1
|
|
General disorders
Grade 1 Edema-limb
|
100.0%
1/1
|
|
Vascular disorders
Grade 1 Hot Flashes
|
100.0%
1/1
|
|
Metabolism and nutrition disorders
Grade 1 Hyperglycemia
|
100.0%
1/1
|
|
Metabolism and nutrition disorders
Grade 1 Hypoalbuminemia
|
100.0%
1/1
|
|
Metabolism and nutrition disorders
Grade 1 Hyponatremia
|
100.0%
1/1
|
|
Metabolism and nutrition disorders
Grade 3 Hyponatremia
|
100.0%
1/1
|
|
General disorders
Grade 1 Injection Site Reaction
|
100.0%
1/1
|
|
General disorders
Grade 2 Injection Site Reaction
|
100.0%
1/1
|
|
General disorders
Gade 1 Fatigue
|
100.0%
1/1
|
|
General disorders
Grade 1 Pain - NOS
|
100.0%
1/1
|
|
Psychiatric disorders
Grade 1 Mood Alteration
|
100.0%
1/1
|
|
Gastrointestinal disorders
Grade 1 Nausea
|
100.0%
1/1
|
|
Blood and lymphatic system disorders
Grade 1 Neutropenia
|
100.0%
1/1
|
|
Blood and lymphatic system disorders
Grade 2 Neutropenia
|
100.0%
1/1
|
|
Skin and subcutaneous tissue disorders
Grade 1 Pruritis
|
100.0%
1/1
|
|
General disorders
Grade 1 Rigors/Chills
|
100.0%
1/1
|
|
Hepatobiliary disorders
Grade 1 SGOT (AST) Increase
|
100.0%
1/1
|
|
Hepatobiliary disorders
Grade 1 SGPT (ALT) Increase
|
100.0%
1/1
|
|
Blood and lymphatic system disorders
Grade 1 Thrombocytopenia
|
100.0%
1/1
|
|
Blood and lymphatic system disorders
Grade 2 Thrombocytopenia
|
100.0%
1/1
|
|
Blood and lymphatic system disorders
Grade 2 Leukopenia
|
100.0%
1/1
|
Additional Information
Frits van Rhee
University of Arkansas for Medical Sciences
Phone: 501-526-6990
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place