Trial Outcomes & Findings for Study of Decadron, Biaxin, and Pomalidomide in Relapsed/Refractory Myeloma (NCT NCT01159574)
NCT ID: NCT01159574
Last Updated: 2019-06-11
Results Overview
Best response rate was recorded for all patients, using the IMWG criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
from baseline to cycle with maximum response, which was achieved on average after 2 cycles
Results posted on
2019-06-11
Participant Flow
Participant milestones
| Measure |
All Patients
ClaPd therapy:
Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.
Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.
dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle
clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle
Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle
|
|---|---|
|
Treatment Phase
STARTED
|
121
|
|
Treatment Phase
COMPLETED
|
100
|
|
Treatment Phase
NOT COMPLETED
|
21
|
|
Follow Up Phase
STARTED
|
112
|
|
Follow Up Phase
COMPLETED
|
92
|
|
Follow Up Phase
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
All Patients
ClaPd therapy:
Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.
Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.
dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle
clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle
Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle
|
|---|---|
|
Treatment Phase
non-evaluable/not included in analysis
|
1
|
|
Treatment Phase
Adverse Event
|
3
|
|
Treatment Phase
Death
|
6
|
|
Treatment Phase
Physician Decision
|
2
|
|
Treatment Phase
Withdrawal by Subject
|
7
|
|
Treatment Phase
still on treatment
|
2
|
|
Follow Up Phase
Lost to Follow-up
|
2
|
|
Follow Up Phase
still being followed for overall surviva
|
18
|
Baseline Characteristics
Study of Decadron, Biaxin, and Pomalidomide in Relapsed/Refractory Myeloma
Baseline characteristics by cohort
| Measure |
All Patients
n=120 Participants
ClaPd therapy:
Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.
Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.
dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle
clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle
Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
112 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 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
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Hemoglobin
|
10.4 g/dL
n=5 Participants
|
|
Range of Prior Therapies
|
5 years
n=5 Participants
|
|
Beta-2 microglobulin at baseline (in mg/L)
|
35 mg/L
n=5 Participants
|
|
lactage dehydrogenase at baseline (U/L)
|
170.5 u/l
n=5 Participants
|
PRIMARY outcome
Timeframe: from baseline to cycle with maximum response, which was achieved on average after 2 cyclesBest response rate was recorded for all patients, using the IMWG criteria.
Outcome measures
| Measure |
All Patients
n=120 Participants
ClaPd therapy:
Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.
Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.
dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle
clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle
Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle
|
|---|---|
|
Overall Response Rate
Not evaluable
|
3 Participants
|
|
Overall Response Rate
stringent Complete Response
|
6 Participants
|
|
Overall Response Rate
Complete Response
|
1 Participants
|
|
Overall Response Rate
Very Good Partial Response
|
20 Participants
|
|
Overall Response Rate
Partial Response
|
43 Participants
|
|
Overall Response Rate
Minimal Response
|
8 Participants
|
|
Overall Response Rate
stable disease
|
29 Participants
|
|
Overall Response Rate
progression of disease
|
10 Participants
|
SECONDARY outcome
Timeframe: From baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 daysOutcome measures
| Measure |
All Patients
n=120 Participants
ClaPd therapy:
Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.
Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.
dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle
clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle
Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle
|
|---|---|
|
Time to Maximum Response, Expressed as Number of Cycles of Treatment to Maximum Response
|
2.19 cycles
Interval 1.0 to 18.0
|
SECONDARY outcome
Timeframe: From start of treatment, to date of disease progressionPopulation: 18 patients were removed from study for reasons other then disease progression; 2 patients are still receiving treatment.
Outcome measures
| Measure |
All Patients
n=100 Participants
ClaPd therapy:
Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.
Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.
dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle
clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle
Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle
|
|---|---|
|
Time to Disease Progression (Progression Free Survival)
|
272 days
Interval 21.0 to 1430.0
|
Adverse Events
All Patients
Serious events: 59 serious events
Other events: 120 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=120 participants at risk
ClaPd therapy:
Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.
Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.
dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle
clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle
Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle
|
|---|---|
|
Renal and urinary disorders
acute renal failure
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Psychiatric disorders
agitation
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Psychiatric disorders
altered mental status
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Blood and lymphatic system disorders
anemia
|
2.5%
3/120 • Number of events 3 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Cardiac disorders
atrial fibrillation
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Psychiatric disorders
behavior changes
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Gastrointestinal disorders
bowel obstruction
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
cellulitis
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Musculoskeletal and connective tissue disorders
chest pain
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Renal and urinary disorders
chronic kidney insufficiency
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Investigations
complications of MM (leading to death)
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Psychiatric disorders
confusion
|
1.7%
2/120 • Number of events 3 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
cough
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
creatinine increased
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
General disorders
death
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
dehydration
|
5.0%
6/120 • Number of events 6 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Gastrointestinal disorders
diarrhea
|
4.2%
5/120 • Number of events 5 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Gastrointestinal disorders
diffuse small bowl ileus
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
diverticullitis
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
2.5%
3/120 • Number of events 3 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
1.7%
2/120 • Number of events 2 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
General disorders
fall
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
General disorders
fatigue
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
fever
|
3.3%
4/120 • Number of events 4 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Musculoskeletal and connective tissue disorders
fracture
|
3.3%
4/120 • Number of events 4 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
gastroenteritis
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Vascular disorders
hypotension
|
2.5%
3/120 • Number of events 3 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Psychiatric disorders
hallunication
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Musculoskeletal and connective tissue disorders
pain (hip, rib)
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Musculoskeletal and connective tissue disorders
pain (rib)
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
hypercalcemia
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
hyperkalemia
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
infection
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Investigations
intrcranial bleed
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Musculoskeletal and connective tissue disorders
lower back pain
|
1.7%
2/120 • Number of events 2 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
lung infection
|
12.5%
15/120 • Number of events 16 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
1.7%
2/120 • Number of events 2 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Gastrointestinal disorders
nausea
|
1.7%
2/120 • Number of events 2 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Blood and lymphatic system disorders
neutropenia
|
2.5%
3/120 • Number of events 3 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
neutropenic fever
|
3.3%
4/120 • Number of events 4 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Blood and lymphatic system disorders
pancytopenia
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
parainfluenza virus infection
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary emboli
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Skin and subcutaneous tissue disorders
rash
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
renal insufficiency
|
3.3%
4/120 • Number of events 4 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
rhinovirus
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
sepsis
|
2.5%
3/120 • Number of events 3 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
skin infection (including cellulitis)
|
2.5%
3/120 • Number of events 4 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Nervous system disorders
suspected seizure
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Psychiatric disorders
syncopal episode
|
1.7%
2/120 • Number of events 2 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
1.7%
2/120 • Number of events 2 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Vascular disorders
thromboembolic event
|
1.7%
2/120 • Number of events 2 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
General disorders
transient word finding difficulity
|
0.83%
1/120 • Number of events 1 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Gastrointestinal disorders
vomiting
|
4.2%
5/120 • Number of events 5 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
General disorders
weakness (including associated pain/tiredness)
|
1.7%
2/120 • Number of events 2 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
Other adverse events
| Measure |
All Patients
n=120 participants at risk
ClaPd therapy:
Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.
Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.
dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle
clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle
Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle
|
|---|---|
|
Nervous system disorders
neuro mood
|
5.0%
6/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Nervous system disorders
psychomotor agitation
|
5.0%
6/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
5.0%
6/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Renal and urinary disorders
renal failure/insufficiency
|
5.0%
6/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
5.0%
6/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
Skin Infection
|
5.0%
6/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
Thrush
|
5.0%
6/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Gastrointestinal disorders
cramping
|
5.8%
7/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Gastrointestinal disorders
dry mouth
|
5.8%
7/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Nervous system disorders
confusion
|
5.8%
7/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Vascular disorders
Lower extremity DVT
|
5.8%
7/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Musculoskeletal and connective tissue disorders
chest pain (muscular)
|
5.8%
7/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Skin and subcutaneous tissue disorders
cushingoid
|
5.8%
7/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
UTI
|
5.8%
7/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Gastrointestinal disorders
dehydration
|
6.7%
8/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
6.7%
8/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
hypernatremia
|
6.7%
8/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Nervous system disorders
agitation
|
6.7%
8/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Nervous system disorders
Paresthesia
|
6.7%
8/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Skin and subcutaneous tissue disorders
rash maculo papular
|
6.7%
8/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Respiratory, thoracic and mediastinal disorders
hoarseness
|
6.7%
8/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Respiratory, thoracic and mediastinal disorders
postnasal drip
|
6.7%
8/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
Pneumonia
|
6.7%
8/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Vascular disorders
bruising
|
7.5%
9/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Renal and urinary disorders
Hyperuricemia
|
7.5%
9/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
hypercalcemia
|
8.3%
10/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
weight gain
|
8.3%
10/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Skin and subcutaneous tissue disorders
facial flushing
|
8.3%
10/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
8.3%
10/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
General disorders
fall
|
8.3%
10/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
weight loss
|
9.2%
11/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Musculoskeletal and connective tissue disorders
pain in general
|
9.2%
11/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Musculoskeletal and connective tissue disorders
pain in legs
|
9.2%
11/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
9.2%
11/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
sore throat
|
9.2%
11/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Gastrointestinal disorders
bloating
|
10.0%
12/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Renal and urinary disorders
CKD
|
10.0%
12/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Gastrointestinal disorders
abdominal pain/discomfort
|
10.8%
13/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Gastrointestinal disorders
flatulance
|
10.8%
13/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
General disorders
generalized weakness
|
10.8%
13/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
fever
|
10.8%
13/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
hyperkalemia
|
11.7%
14/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Nervous system disorders
headache
|
11.7%
14/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Musculoskeletal and connective tissue disorders
hip pain
|
11.7%
14/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Gastrointestinal disorders
vomiting
|
12.5%
15/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Musculoskeletal and connective tissue disorders
rib pain
|
12.5%
15/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Skin and subcutaneous tissue disorders
rash
|
12.5%
15/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
anorexia
|
14.2%
17/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Nervous system disorders
anxiety/stress
|
14.2%
17/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Gastrointestinal disorders
dyspepsia
|
15.0%
18/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Musculoskeletal and connective tissue disorders
shoulder pain
|
15.0%
18/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Eye disorders
blurry vision
|
15.0%
18/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
elevated AST
|
15.8%
19/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Nervous system disorders
depression
|
15.8%
19/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Nervous system disorders
dysgeusia
|
15.8%
19/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
lung infection
|
15.8%
19/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Musculoskeletal and connective tissue disorders
muscle spasms/cramps
|
18.3%
22/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Gastrointestinal disorders
nausea
|
19.2%
23/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
19.2%
23/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
Hypokalemia
|
19.2%
23/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
cough
|
20.0%
24/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Nervous system disorders
dizziness / lightheaded
|
20.8%
25/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Infections and infestations
URI
|
22.5%
27/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Nervous system disorders
tremor
|
24.2%
29/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
30/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.8%
31/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Gastrointestinal disorders
constipation
|
26.7%
32/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
27.5%
33/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
elevated ALT
|
30.0%
36/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
elevated ALK
|
30.0%
36/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
General disorders
insomnia
|
30.0%
36/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Nervous system disorders
peripheral neuropathy
|
30.8%
37/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Vascular disorders
edema
|
31.7%
38/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Musculoskeletal and connective tissue disorders
back pain
|
32.5%
39/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Gastrointestinal disorders
diarrhea
|
36.7%
44/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
increased creatinine
|
38.3%
46/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
42.5%
51/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
hyponatremia
|
51.7%
62/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
hypocalcemia
|
55.0%
66/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
58.3%
70/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
hypoglycemia
|
60.8%
73/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Blood and lymphatic system disorders
Anemia
|
61.7%
74/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
General disorders
fatigue
|
62.5%
75/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Metabolism and nutrition disorders
hyperglycemia
|
64.2%
77/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
70.8%
85/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Blood and lymphatic system disorders
Leukopenia
|
71.7%
86/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Blood and lymphatic system disorders
Lymphopenia
|
74.2%
89/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
|
Blood and lymphatic system disorders
Neutropenia
|
82.5%
99/120 • Adverse events were recorded from baseline until removal from study. Serious adverse events were recorded from baseline until 30 days after the last dose of study drug.
Adverse events were recorded using the CTCAE version 4.0. The adverse events listed includes serious adverse events. Serious adverse events were recorded from baseline unti
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60