Trial Outcomes & Findings for UARK 2012-02 Trial For High-Risk Myeloma Evaluating Accelerating and Sustaining Complete Remission (NCT NCT02128230)
NCT ID: NCT02128230
Last Updated: 2021-06-22
Results Overview
Toward improving the clinical outcomes of research subjects with high-risk MM (HR-MM) in the context of the immediately preceding TT5 trial 2008-02 and TT3 trials 2003-33 and 2006-66, TT5B will attempt to accelerate and sustain, at 2 years from starting therapy, the proportion of subjects in complete remission (AS-CR-2) by reducing host-imposed toxicity and thus facilitating timely completion of highly synergistic 8-drug combination therapy, including the next generation proteasome inhibitor, Carfilzomib (CFZ). This will result in avoiding MM re-growth that, we postulate, ensued in TT3 during recovery phases from severe de-conditioning. Furthermore, we speculate that the incidence of positive minimal residual disease (MRD) will be reduced with the addition of one cycle of consolidation therapy.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
from baseline to either death or study completion for each subject (up to approximately 48 months)
Results posted on
2021-06-22
Participant Flow
Participant milestones
| Measure |
Study Treatment
MEL-CFZ-TD-PACE: Melphalan and Carfilzomib will be given into a central venous catheter. Dexamethasone is a pill that is taken by mouth daily for 4 days. Thalidomide is a capsule taken by mouth for 4 days. Cisplatin, Adriamycin, Cyclophosphamide and Etoposide are all given into the vein (IV) by a continuous infusion through a central catheter for 4 days. After completion of the four days of continuous chemotherapy, a drug G-CSF will be given. This is a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
UARK 2012-02 Trial For High-Risk Myeloma Evaluating Accelerating and Sustaining Complete Remission
Baseline characteristics by cohort
| Measure |
Study Treatment
n=20 Participants
MEL-CFZ-TD-PACE: Melphalan and Carfilzomib will be given into a central venous catheter. Dexamethasone is a pill that is taken by mouth daily for 4 days. Thalidomide is a capsule taken by mouth for 4 days. Cisplatin, Adriamycin, Cyclophosphamide and Etoposide are all given into the vein (IV) by a continuous infusion through a central catheter for 4 days. After completion of the four days of continuous chemotherapy, a drug G-CSF will be given. This is a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=93 Participants
|
|
Age, Continuous
|
63.5 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: from baseline to either death or study completion for each subject (up to approximately 48 months)Population: Nineteen (19) subjects discontinued study prior to completion. Only one (1) subject completed all study related activities.
Toward improving the clinical outcomes of research subjects with high-risk MM (HR-MM) in the context of the immediately preceding TT5 trial 2008-02 and TT3 trials 2003-33 and 2006-66, TT5B will attempt to accelerate and sustain, at 2 years from starting therapy, the proportion of subjects in complete remission (AS-CR-2) by reducing host-imposed toxicity and thus facilitating timely completion of highly synergistic 8-drug combination therapy, including the next generation proteasome inhibitor, Carfilzomib (CFZ). This will result in avoiding MM re-growth that, we postulate, ensued in TT3 during recovery phases from severe de-conditioning. Furthermore, we speculate that the incidence of positive minimal residual disease (MRD) will be reduced with the addition of one cycle of consolidation therapy.
Outcome measures
| Measure |
Total Therapy 5B
n=20 Participants
Induction 1 - MEL-10+CFZ-TD-PACE, Optional Bridging with TD, First Transplant - MEL-80+CFZ-TD-PACE + PBSC, Optional Bridging with TD, Inter-Therapy - MEL-20+CFZ-TD-PACE (75%), Optional Bridging with TD, Second Transplant - MEL-80+CFZ-TD-PACE + PBSC, Optional Bridging with TD, Consolidation - CFZ-TD-PACE, Maintenance - CFZ-R(T)-D
|
|---|---|
|
The Remission Rate for Participants With High-risk Myeloma
|
0 Participants
|
Adverse Events
Study Treatment
Serious events: 13 serious events
Other events: 20 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Study Treatment
n=20 participants at risk
MEL-CFZ-TD-PACE: Melphalan and Carfilzomib will be given into a central venous catheter. Dexamethasone is a pill that is taken by mouth daily for 4 days. Thalidomide is a capsule taken by mouth for 4 days. Cisplatin, Adriamycin, Cyclophosphamide and Etoposide are all given into the vein (IV) by a continuous infusion through a central catheter for 4 days. After completion of the four days of continuous chemotherapy, a drug G-CSF will be given. This is a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy.
|
|---|---|
|
Cardiac disorders
Hospitalization for Syncope
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for Parainfluenza
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Blood and lymphatic system disorders
Hospitalization for Hematuria
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for K. Pneumonia UTI
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Hospitalization for Neutropenic Colitis
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Colitis / Grade 3
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Immune system disorders
Leukopenia / Grade 2
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Immune system disorders
Neutropenia / Grade 3
|
20.0%
4/20 • Number of events 5 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
General disorders
Hospitalization for Uncontrolled Pain
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for Shortness of Breath
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Cardiac disorders
Hospitalization for Sinus Bradycardia
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Cardiac disorders
Hospitalization for Atrial Fibrillation
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for Hypoxia
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Renal and urinary disorders
Acute Kidney Injury
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
General disorders
Hospitalization for Chest Pain
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization Influenza
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Injury, poisoning and procedural complications
Hospitalization for L. hip pain
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Blood and lymphatic system disorders
Myelodysplastic Snydrome (MDS)
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Blood and lymphatic system disorders
Acute Myeloid Leukemia (AML)
|
5.0%
1/20 • Number of events 1 • From baseline to either death or study completion for each subject (up to 48 months)
|
Other adverse events
| Measure |
Study Treatment
n=20 participants at risk
MEL-CFZ-TD-PACE: Melphalan and Carfilzomib will be given into a central venous catheter. Dexamethasone is a pill that is taken by mouth daily for 4 days. Thalidomide is a capsule taken by mouth for 4 days. Cisplatin, Adriamycin, Cyclophosphamide and Etoposide are all given into the vein (IV) by a continuous infusion through a central catheter for 4 days. After completion of the four days of continuous chemotherapy, a drug G-CSF will be given. This is a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
20/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
35.0%
7/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
45.0%
9/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
100.0%
20/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
95.0%
19/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
100.0%
20/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Blood and lymphatic system disorders
Wbc decrease (leukopenia)
|
100.0%
20/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Cardiac disorders
Cardiac disorders - other
|
20.0%
4/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Cardiac disorders
Heart failure
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Cardiac disorders
Sinus bradycardia
|
40.0%
8/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Cardiac disorders
Sinus tachycardia
|
40.0%
8/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Cardiac disorders
Supraventricular tachycardia
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Cardiac disorders
Ventricular tachycardia
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Ear and labyrinth disorders
Ear pain
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Ear and labyrinth disorders
Hearing impaired
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Ear and labyrinth disorders
Vestibular Disorder
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Eye disorders
Blurred vision
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Eye disorders
Dry eye
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Eye disorders
Eye disorders - Other,
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Eye disorders
Floaters
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Eye disorders
Watering eyes
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Abdominal distension
|
35.0%
7/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
5/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Anal hemorrhage
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Bloating
|
20.0%
4/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Colitis
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Colonic perforation
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Constipation
|
80.0%
16/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Diarrhea
|
90.0%
18/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
30.0%
6/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Dysphagia
|
30.0%
6/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Enterocolitis
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Esophageal obstruction
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Esophageal pain
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
25.0%
5/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other,
|
20.0%
4/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Gastroparesis
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Hemorrhoids
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Mucositis oral
|
35.0%
7/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Nausea
|
100.0%
20/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Rectal pain
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Stomach pain
|
20.0%
4/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Toothache
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
General disorders
Chills
|
40.0%
8/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
General disorders
Edema face
|
25.0%
5/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
General disorders
Edema limbs
|
70.0%
14/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
General disorders
Edema trunk
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
General disorders
Fatigue
|
90.0%
18/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
General disorders
Fever
|
50.0%
10/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
General disorders
Flu like symptoms
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
General disorders
Gait disturbance
|
20.0%
4/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
General disorders
Malaise
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
General disorders
Neck edema
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
General disorders
Non-cardiac chest pain
|
30.0%
6/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
General disorders
Pain
|
55.0%
11/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
75.0%
15/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Hepatobiliary disorders
Alkaline phosphatase increased
|
80.0%
16/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
70.0%
14/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Hepatobiliary disorders
Blood bilrubin increased
|
35.0%
7/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
100.0%
20/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Immune system disorders
Allergic reaction
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Immune system disorders
Immune system disorders - Other,
|
30.0%
6/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Infections and infestations
Abdominal infection
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Infections and infestations
Infections and infestations - Other,
|
55.0%
11/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Infections and infestations
Lung infection
|
25.0%
5/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Infections and infestations
Otitis media
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Infections and infestations
Pharyngitis
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Infections and infestations
Rhinitis infective
|
35.0%
7/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Infections and infestations
Sepsis
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Infections and infestations
Sinusitis
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Infections and infestations
Skin infection
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Infections and infestations
Upper respiratory infection
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Infections and infestations
Urinary tract infection
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Injury, poisoning and procedural complications
Bruising
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Investigations
Ejection fraction decreased
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Investigations
Weight gain
|
45.0%
9/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Metabolism and nutrition disorders
Anorexia
|
45.0%
9/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
15.0%
3/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
20/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
35.0%
7/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
15.0%
3/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Metabolism and nutrition disorders
Hypernatremia
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
20/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
80.0%
16/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
100.0%
20/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
20/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
15.0%
3/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
70.0%
14/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
50.0%
10/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
15.0%
3/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
15.0%
3/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other,
|
25.0%
5/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.0%
3/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
5/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Nervous system disorders
Ataxia
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Nervous system disorders
Dizziness
|
55.0%
11/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Nervous system disorders
Dysgeusia
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Nervous system disorders
Dysphasia
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Nervous system disorders
Facial nerve disorder
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Nervous system disorders
Headache
|
45.0%
9/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Nervous system disorders
Myelitis
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Nervous system disorders
Neuralgia
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Nervous system disorders
Paresthesia
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Nervous system disorders
Peripheral motor neuropathy
|
15.0%
3/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
70.0%
14/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Nervous system disorders
Presyncope
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Nervous system disorders
Sinus pain
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Nervous system disorders
Syncope
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Nervous system disorders
Tremor
|
20.0%
4/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Psychiatric disorders
Anxiety
|
40.0%
8/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Psychiatric disorders
Confusion
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Psychiatric disorders
Depression
|
20.0%
4/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Psychiatric disorders
Insomnia
|
55.0%
11/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Renal and urinary disorders
Chronic kidney disease
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Renal and urinary disorders
Creatinine increased
|
75.0%
15/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Renal and urinary disorders
Hematuria
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Renal and urinary disorders
Renal and urinary disorders - Other,
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Renal and urinary disorders
Urinary frequency
|
30.0%
6/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Renal and urinary disorders
Urinary retention
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Renal and urinary disorders
Urinary urgency
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
60.0%
12/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
60.0%
12/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
55.0%
11/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
30.0%
6/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
15.0%
3/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
30.0%
6/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
25.0%
5/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
25.0%
5/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
30.0%
6/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
30.0%
6/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Skin and subcutaneous tissue disorders
Dermatology/skin - bruising
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
4/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
3/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
10.0%
2/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
35.0%
7/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other,
|
15.0%
3/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Social circumstances
Social circumstances - Other,
|
25.0%
5/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Vascular disorders
Flushing
|
15.0%
3/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Vascular disorders
Hot flashes
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Vascular disorders
Hypertension
|
65.0%
13/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Vascular disorders
Hypotension
|
70.0%
14/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
|
Vascular disorders
Thromboembolic event
|
5.0%
1/20 • From baseline to either death or study completion for each subject (up to 48 months)
|
Additional Information
Frits Van Rhee, MD
University of Arkansas for Medical Sciences
Phone: 501-526-2873
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place