Trial Outcomes & Findings for UARK 2010-35, A Study of Expanded Natural Killer Cell Therapy for Multiple Myeloma (NCT NCT01313897)
NCT ID: NCT01313897
Last Updated: 2017-05-19
Results Overview
Number of participants with an objective response of Partial Response (PR) or better according to European Society for Blood and Marrow Transplantation (EBMT) criteria within 180 days post Expanded Natural Killer Cell Infusion. The minimum criteria to meet the EBMT definition of PR or better included: \>= 50% reduction in size of soft tissue plasmacytomas (if assessed); AND \>= 50% reduction in plasma cells in bone marrow biopsy (if biopsy was performed and if \>= 30% plasma cells at baseline); AND \>=50% reduction in serum M protein and reduction in urine M protein \>= 90% or to 200 mg/24hr OR \>= 50% decrease in the difference between involved and uninvolved serum free light chain levels (if serum M protein \< 1 g/dL, urine \< 200 mg/24 hrs, and an involved serum free light chain level \>= 10 mg/dL at baseline).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
180 days
Results posted on
2017-05-19
Participant Flow
Participant milestones
| Measure |
Study Treatment
Bortezomib (1.0 mg/m2, IV) Days -9,-6,-2 (3 doses) Mesna (30 mg/kg, IV) Days -7, -6 (2 doses) Cyclophasphamide (60 mg/kg, IV) Day -7 (1 dose) Dexamethasone (40 mg, PO) Days -6 to -3 (4 doses) Expanded Natural Killer (exp-NK) Cell Infusion Day 0 (1 dose) Aldesleukin (IL-2) (3x10\^6 IU, SC) Days 0 to 12 (13 doses)
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
UARK 2010-35, A Study of Expanded Natural Killer Cell Therapy for Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Study Treatment
n=10 Participants
Bortezomib (1.0 mg/m2, IV) Days -9,-6,-2 (3 doses) Mesna (30 mg/kg, IV) Days -7, -6 (2 doses) Cyclophasphamide (60 mg/kg, IV) Day -7 (1 dose) Dexamethasone (40 mg, PO) Days -6 to -3 (4 doses) Expanded Natural Killer (exp-NK) Cell Infusion Day 0 (1 dose) Aldesleukin (IL-2) (3x10\^6 IU, SC) Days 0 to 12 (13 doses)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 180 daysNumber of participants with an objective response of Partial Response (PR) or better according to European Society for Blood and Marrow Transplantation (EBMT) criteria within 180 days post Expanded Natural Killer Cell Infusion. The minimum criteria to meet the EBMT definition of PR or better included: \>= 50% reduction in size of soft tissue plasmacytomas (if assessed); AND \>= 50% reduction in plasma cells in bone marrow biopsy (if biopsy was performed and if \>= 30% plasma cells at baseline); AND \>=50% reduction in serum M protein and reduction in urine M protein \>= 90% or to 200 mg/24hr OR \>= 50% decrease in the difference between involved and uninvolved serum free light chain levels (if serum M protein \< 1 g/dL, urine \< 200 mg/24 hrs, and an involved serum free light chain level \>= 10 mg/dL at baseline).
Outcome measures
| Measure |
Velcade for Anti-MM Therapy
n=8 Participants
Day(s) -9,-6,-2 3 doses of Bortezomib at 1.0 mg/m2, i.v.
Bortezomib: bortezomib given days -9, -6, and -2 at 1.0mg/m2, i.v.
|
|---|---|
|
Therapeutic Efficacy
|
1 Participants
|
Adverse Events
Study Treatment
Serious events: 6 serious events
Other events: 8 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Study Treatment
n=8 participants at risk
Bortezomib (1.0 mg/m2, IV) Days -9,-6,-2 (3 doses) Mesna (30 mg/kg, IV) Days -7, -6 (2 doses) Cyclophasphamide (60 mg/kg, IV) Day -7 (1 dose) Dexamethasone (40 mg, PO) Days -6 to -3 (4 doses) Expanded Natural Killer (exp-NK) Cell Infusion Day 0 (1 dose) Aldesleukin (IL-2) (3x10\^6 IU, SC) Days 0 to 12 (13 doses)
|
|---|---|
|
Blood and lymphatic system disorders
Grade 4 Anemia
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Blood and lymphatic system disorders
Grade 4 Thrombocytopenia
|
75.0%
6/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Blood and lymphatic system disorders
Grade 4 Leukopenia
|
75.0%
6/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
General disorders
Grade 3 Constitutional Symptoms - Other
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
General disorders
Grade 2 Fever
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
General disorders
Grade 2 Rigors/Chills
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Skin and subcutaneous tissue disorders
Grade 3 Skin Rash
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Gastrointestinal disorders
Grade 3 Diarrhea
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Gastrointestinal disorders
Grade 3 Mucositis/Stomatitis
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Gastrointestinal disorders
Grade 2 Nausea
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Infections and infestations
Grade 5 Sepsis
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Infections and infestations
Grade 3 Infection - other
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Infections and infestations
Grade 5 Pneumonia
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
Other adverse events
| Measure |
Study Treatment
n=8 participants at risk
Bortezomib (1.0 mg/m2, IV) Days -9,-6,-2 (3 doses) Mesna (30 mg/kg, IV) Days -7, -6 (2 doses) Cyclophasphamide (60 mg/kg, IV) Day -7 (1 dose) Dexamethasone (40 mg, PO) Days -6 to -3 (4 doses) Expanded Natural Killer (exp-NK) Cell Infusion Day 0 (1 dose) Aldesleukin (IL-2) (3x10\^6 IU, SC) Days 0 to 12 (13 doses)
|
|---|---|
|
Immune system disorders
Grade 1 Rhinitis
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Immune system disorders
Grade 2 Rhinitis
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Blood and lymphatic system disorders
Grade 1 Anemia
|
87.5%
7/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Blood and lymphatic system disorders
Grade 2 Anemia
|
100.0%
8/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Blood and lymphatic system disorders
Grade 3 Anemia
|
75.0%
6/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Blood and lymphatic system disorders
Grade 1 Blood - Other
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Blood and lymphatic system disorders
Grade 2 Blood - Other
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Blood and lymphatic system disorders
Grade 1 Thrombocytopenia
|
50.0%
4/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Blood and lymphatic system disorders
Grade 2 Thrombocytopenia
|
62.5%
5/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Blood and lymphatic system disorders
Grade 3 Thrombocytopenia
|
87.5%
7/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Blood and lymphatic system disorders
Grade 2 Leukopenia
|
100.0%
8/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Blood and lymphatic system disorders
Grade 3 Leukopenia
|
87.5%
7/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Cardiac disorders
Grade 2 Cardiac General - Other
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Cardiac disorders
Grade 2 Hypotension
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
General disorders
Grade 1 Fatigue
|
37.5%
3/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
General disorders
Grade 2 Fatigue
|
50.0%
4/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
General disorders
Grade 1 Fever
|
37.5%
3/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
General disorders
Grade 2 Fever
|
25.0%
2/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
General disorders
Grade 1 Rigors/Chills
|
37.5%
3/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
General disorders
Grade 2 Rigors/Chills
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
General disorders
Grade 1 Sweating
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
General disorders
Grade 1 Weight Loss
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Skin and subcutaneous tissue disorders
Grade 1 Alopecia
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Skin and subcutaneous tissue disorders
Grade 2 Alopecia
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Skin and subcutaneous tissue disorders
Grade 1 Dermatology - Other
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Skin and subcutaneous tissue disorders
Grade 2 Dermatology - Other
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Skin and subcutaneous tissue disorders
Grade 2 Dry Skin
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Skin and subcutaneous tissue disorders
Grade 1 Skin Rash
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Endocrine disorders
Grade 2 Hypothyroidism
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Gastrointestinal disorders
Grade 1 Anorexia
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Gastrointestinal disorders
Grade 2 Anorexia
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Gastrointestinal disorders
Grade 1 Diarrhea
|
37.5%
3/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Gastrointestinal disorders
Grade 2 Diarrhea
|
25.0%
2/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Gastrointestinal disorders
Grade 1 Dry Mouth
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Gastrointestinal disorders
Grade 1 Nausea
|
62.5%
5/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Gastrointestinal disorders
Grade 2 Nausea
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Hepatobiliary disorders
Grade 1 Alkaline Phosphatase Increase
|
50.0%
4/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Hepatobiliary disorders
Grade 1 Bilirubin Increase
|
37.5%
3/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Hepatobiliary disorders
Grade 2 Bilirubin Increase
|
25.0%
2/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Hepatobiliary disorders
Grade 3 Bilirubin Increase
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Hepatobiliary disorders
Grade 1 Hypoalbuminemia
|
87.5%
7/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Hepatobiliary disorders
Grade 2 Hypoalbuminemia
|
75.0%
6/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Hepatobiliary disorders
Grade 1 SGOT (AST) Increase
|
50.0%
4/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Hepatobiliary disorders
Grade 2 SGOT (AST) Increase
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Hepatobiliary disorders
Grade 4 SGOT (AST) Increase
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Hepatobiliary disorders
Grade 1 SGPT (ALT) Increase
|
37.5%
3/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Hepatobiliary disorders
Grade 2 SGPT (ALT) Increase
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Hepatobiliary disorders
Grade 3 SGPT (ALT) Increase
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Hepatobiliary disorders
Grade 4 SGPT (ALT) Increase
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Infections and infestations
Grade 3 Febrile Neutropenia
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Infections and infestations
Grade 3 Urinary Tract Infection
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Infections and infestations
Grade 2 Pneumonia
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Blood and lymphatic system disorders
Grade 2 Edema - Trunk/Genital
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 1 Bicarbonate Decrease
|
62.5%
5/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 2 Bicarbonate Decrease
|
25.0%
2/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 3 Bicarbonate Disease
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 1 Hyperglycemia
|
87.5%
7/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 2 Hyperglycemia
|
62.5%
5/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 3 Hyperglycemia
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 1 Hyperkalemia
|
25.0%
2/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 2 Hyperkalemia
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 3 Hyperkalemia
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 1 Hypermagnesemia
|
75.0%
6/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 3 Hypermagnesemia
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 1 Hypernatremia
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 2 Hypocalcemia
|
87.5%
7/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 3 Hypocalcemia
|
37.5%
3/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 4 Hypocalcemia
|
25.0%
2/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 1 Hypokalemia
|
87.5%
7/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 3 Hypokalemia
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 1 Hypomagnesemia
|
25.0%
2/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 2 Hypomagnesemia
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 1 Hyponatremia
|
87.5%
7/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 3 Hyponatremia
|
37.5%
3/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 1 Hypophosphatemia
|
50.0%
4/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 2 Hypophosphatemia
|
87.5%
7/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 3 Hypophosphatemia
|
75.0%
6/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Metabolism and nutrition disorders
Grade 4 Hypophosphatemia
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Musculoskeletal and connective tissue disorders
Grade 1 Gait/Walking
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Musculoskeletal and connective tissue disorders
Grade 2 Muscle Weakness: Whole Body
|
50.0%
4/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Musculoskeletal and connective tissue disorders
Grade 3 Muscle Weakness: Whole Body
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Psychiatric disorders
Grade 1 Confusion
|
25.0%
2/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Psychiatric disorders
Grade 2 Confusion
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Psychiatric disorders
Grade 3 Confusion
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Psychiatric disorders
Grade 4 Confusion
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
General disorders
Grade 1 Dizziness
|
25.0%
2/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Psychiatric disorders
Grade 1 Memory Impairment
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Psychiatric disorders
Grade 1 Mood Alteration
|
25.0%
2/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Psychiatric disorders
Grade 2 Mood Alteration
|
25.0%
2/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Nervous system disorders
Grade 1 Sensory Neuropathy
|
25.0%
2/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Nervous system disorders
Grade 2 Sensory Neuropathy
|
25.0%
2/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
General disorders
Grade 3 Pain: Abdomen - NOS
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
General disorders
Grade 1 Headache
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Musculoskeletal and connective tissue disorders
Grade 2 Pain: Joint
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Musculoskeletal and connective tissue disorders
Grade 1 Pain: Lower Back
|
25.0%
2/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Musculoskeletal and connective tissue disorders
Grade 2 Pain: Middle Back
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
General disorders
Grade 1 Pain - NOS
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Musculoskeletal and connective tissue disorders
Grade 2 Pain: Upper Back
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Bronchospasm
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 Cough
|
50.0%
4/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Cough
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 Dyspnea
|
25.0%
2/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Dyspnea
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 3 Dyspnea
|
37.5%
3/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1 Nasal/Paranasal Reactions
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 2 Pulmonary - Other
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Renal and urinary disorders
Grade 1 Creatinine Increase
|
50.0%
4/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Renal and urinary disorders
Grade 2 Creatinine Increase
|
25.0%
2/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
|
Vascular disorders
Grade 2 Thrombosis/Embolism
|
12.5%
1/8 • Data were collected from initiation of study therapy through 180 days post expanded natural killer cell infusion.
|
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