Trial Outcomes & Findings for 1454GCC: Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma (NCT NCT02289222)
NCT ID: NCT02289222
Last Updated: 2019-11-05
Results Overview
Establish the safety and tolerability of Pomalidomide and Dexamethasone in combination with MK-3475
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
48 participants
Primary outcome timeframe
24 month
Results posted on
2019-11-05
Participant Flow
Participants were recruited from the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center between December 2014 and May 2016.
Participant milestones
| Measure |
Pomalidomide, Dexamethasone & MK-3475
Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14).
MK-3475: Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks.
Pomalidomide: Pomalidomide is given at standard dose of 4 mg daily orally for 21 days
Dexamethasone: Dexamethasone is given at 40 mg orally weekly
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
1454GCC: Anti-PD-1 (MK-3475) and IMiD (Pomalidomide) Combination Immunotherapy in Relapsed/Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Pomalidomide, Dexamethasone & MK-3475
n=48 Participants
Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14).
MK-3475: Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks.
Pomalidomide: Pomalidomide is given at standard dose of 4 mg daily orally for 21 days
Dexamethasone: Dexamethasone is given at 40 mg orally weekly
|
|---|---|
|
Age, Continuous
|
64 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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
|
18 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 24 monthEstablish the safety and tolerability of Pomalidomide and Dexamethasone in combination with MK-3475
Outcome measures
| Measure |
Pomalidomide, Dexamethasone & MK-3475
n=48 Participants
Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14).
MK-3475: Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks.
Pomalidomide: Pomalidomide is given at standard dose of 4 mg daily orally for 21 days
Dexamethasone: Dexamethasone is given at 40 mg orally weekly
|
|---|---|
|
The Number of Participants With Adverse Events
|
48 Participants
|
SECONDARY outcome
Timeframe: Tissue sample collection will take place before starting study therapy with MK-3475 at baseline and again at time of relapse as defined by the International Myeloma Working Group Response Criteria (Average of up to 24months)Population: Data were analyzed for 29 samples.
The identification of a biomarker for response by evaluating PD-1/PDL-1 expression in patients' bone marrow aspirate samples will be analyzed in order to help select patients for future anti-PD-1 therapy. The main exploratory biomarker analysis was to examine potential correlation between expression of PD-1 on T cells and PD-L1 on myeloma cells with clinical outcome using the following parameters: response rate focusing on responses ≥ very good partial response (VGPR) and PFS. SAS software (v.9.4; SAS Institute, Inc, Cary, NC) was used for statistical analyses.
Outcome measures
| Measure |
Pomalidomide, Dexamethasone & MK-3475
n=29 Participants
Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14).
MK-3475: Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks.
Pomalidomide: Pomalidomide is given at standard dose of 4 mg daily orally for 21 days
Dexamethasone: Dexamethasone is given at 40 mg orally weekly
|
|---|---|
|
PD-LI Expression On Myeloma Cells
Negative
|
10 Participants
|
|
PD-LI Expression On Myeloma Cells
Weak Positive
|
6 Participants
|
|
PD-LI Expression On Myeloma Cells
Positive
|
13 Participants
|
SECONDARY outcome
Timeframe: PFS assessments will take place after starting study therapy with MD-3475 and will continue until the start of a new anti-neoplastic therapy, disease progression, death, or the end of study up to an average of 24 months.PFS will be measured in all participants. Survival and PFS functions were estimated using the Kaplan-Meier method. The Cox regression model was used to assess the following plausible risk factors for OS and PFS: age, isotype, number of cycles of therapy, and cytogenetic profile.
Outcome measures
| Measure |
Pomalidomide, Dexamethasone & MK-3475
n=48 Participants
Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14).
MK-3475: Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks.
Pomalidomide: Pomalidomide is given at standard dose of 4 mg daily orally for 21 days
Dexamethasone: Dexamethasone is given at 40 mg orally weekly
|
|---|---|
|
Time to Progression Free Survival (PFS)
|
17.4 Months
Interval 11.7 to 18.8
|
Adverse Events
Pomalidomide, Dexamethasone & MK-3475
Serious events: 27 serious events
Other events: 48 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Pomalidomide, Dexamethasone & MK-3475
n=48 participants at risk
Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14).
MK-3475: Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks.
Pomalidomide: Pomalidomide is given at standard dose of 4 mg daily orally for 21 days
Dexamethasone: Dexamethasone is given at 40 mg orally weekly
|
|---|---|
|
Cardiac disorders
acute coronary syndrome
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Cardiac disorders
heart failure
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Cardiac disorders
cardiac arrest
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Endocrine disorders
adrenal insufficiency
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Gastrointestinal disorders
colitis
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Gastrointestinal disorders
lower gastrointestinal hemorrhage
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
General disorders
fever
|
4.2%
2/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Injury, poisoning and procedural complications
fracture
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Injury, poisoning and procedural complications
hip fracture
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Infections and infestations
other, bacteremia
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Infections and infestations
skin infection
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Investigations
alanine aminotransferase increased
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Investigations
alkaline phosphatase increased
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Investigations
creatinine increased
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Metabolism and nutrition disorders
hyponatremia
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
other, meniscus tear
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
other, breast cancer
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Nervous system disorders
intracranial hemorrhage
|
4.2%
2/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Nervous system disorders
syncope
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Renal and urinary disorders
urinary retention
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
4.2%
2/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
lung infection
|
18.8%
9/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
4.2%
2/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Vascular disorders
hypotension
|
2.1%
1/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
Other adverse events
| Measure |
Pomalidomide, Dexamethasone & MK-3475
n=48 participants at risk
Pomalidomide is given at standard dose of 4 mg daily orally for 21 days and dexamethasone is given at 40 mg orally weekly. MK3475 will be given as an intravenous infusion at 200 mg every 2 weeks (days 1 and 14).
MK-3475: Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks.
Pomalidomide: Pomalidomide is given at standard dose of 4 mg daily orally for 21 days
Dexamethasone: Dexamethasone is given at 40 mg orally weekly
|
|---|---|
|
Blood and lymphatic system disorders
anemia
|
54.2%
26/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Blood and lymphatic system disorders
lymphocyte count decreased
|
29.2%
14/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Blood and lymphatic system disorders
neutrophil count decreased
|
62.5%
30/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Blood and lymphatic system disorders
platelet count decreased
|
56.2%
27/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Blood and lymphatic system disorders
white blood cell decreased
|
58.3%
28/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Cardiac disorders
atrial fibrillation
|
6.2%
3/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Cardiac disorders
palpitations
|
12.5%
6/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Cardiac disorders
sinus tachycardia
|
10.4%
5/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Ear and labyrinth disorders
ear pain
|
6.2%
3/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Endocrine disorders
hypothyroidism
|
10.4%
5/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Eye disorders
blurred vision
|
22.9%
11/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Gastrointestinal disorders
abdominal pain
|
12.5%
6/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Gastrointestinal disorders
bloating
|
10.4%
5/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Gastrointestinal disorders
constipation
|
39.6%
19/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Gastrointestinal disorders
diarrhea
|
35.4%
17/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
6.2%
3/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Gastrointestinal disorders
nausea
|
20.8%
10/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Gastrointestinal disorders
stomach pain
|
6.2%
3/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Gastrointestinal disorders
vomiting
|
12.5%
6/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
General disorders
chest pain- non cardiac
|
6.2%
3/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
General disorders
chest pain- unspecified
|
10.4%
5/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
General disorders
chills
|
10.4%
5/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
General disorders
edema limbs
|
39.6%
19/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
General disorders
fatigue
|
47.9%
23/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
General disorders
fever
|
10.4%
5/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
General disorders
other, common cold
|
20.8%
10/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
General disorders
pain
|
6.2%
3/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Injury, poisoning and procedural complications
bruising
|
8.3%
4/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Injury, poisoning and procedural complications
fall
|
20.8%
10/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Injury, poisoning and procedural complications
fracture
|
8.3%
4/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Injury, poisoning and procedural complications
spinal fracture
|
6.2%
3/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Infections and infestations
skin infection
|
8.3%
4/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Infections and infestations
urinary tract infection
|
8.3%
4/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Investigations
activated partial thromboplastin time prolonged
|
8.3%
4/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Investigations
alanine aminotransferase increased
|
31.2%
15/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Investigations
alkaline phosphatase increased
|
14.6%
7/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Investigations
aspartate aminotransferase increased
|
31.2%
15/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Investigations
blood bilirubin increased
|
8.3%
4/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Investigations
creatinine increased
|
39.6%
19/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Investigations
weight gain
|
14.6%
7/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Investigations
weight loss
|
8.3%
4/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Metabolism and nutrition disorders
hypercalcemia
|
14.6%
7/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
62.5%
30/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
22.9%
11/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Metabolism and nutrition disorders
hypernatremia
|
8.3%
4/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Metabolism and nutrition disorders
hyperuricemia
|
16.7%
8/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
29.2%
14/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Metabolism and nutrition disorders
hypocalcemia
|
33.3%
16/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Metabolism and nutrition disorders
hypoglycemia
|
16.7%
8/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Metabolism and nutrition disorders
hypokalemia
|
22.9%
11/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Metabolism and nutrition disorders
hypomagenesemia
|
31.2%
15/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Metabolism and nutrition disorders
hyponatremia
|
37.5%
18/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Metabolism and nutrition disorders
hypohosphatemia
|
18.8%
9/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
25.0%
12/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
8.3%
4/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
41.7%
20/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
18.8%
9/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
chest wall pain
|
8.3%
4/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
flank pain
|
6.2%
3/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
generalized muscle weakness
|
8.3%
4/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
other, muscle cramp
|
29.2%
14/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
33.3%
16/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Nervous system disorders
dizziness
|
47.9%
23/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Nervous system disorders
headache
|
39.6%
19/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Nervous system disorders
other, peripheral neuropathy NOS
|
10.4%
5/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Nervous system disorders
tremor
|
18.8%
9/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Psychiatric disorders
anxiety
|
12.5%
6/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Psychiatric disorders
confusion
|
12.5%
6/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Psychiatric disorders
insomnia
|
27.1%
13/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
16.7%
8/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
54.2%
26/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
epitaxis
|
12.5%
6/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
6.2%
3/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
lung infection
|
6.2%
3/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
18.8%
9/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
12.5%
6/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
10.4%
5/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
39.6%
19/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
16.7%
8/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Skin and subcutaneous tissue disorders
other, rash unspecified
|
20.8%
10/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Skin and subcutaneous tissue disorders
pruritis
|
20.8%
10/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Skin and subcutaneous tissue disorders
rash maculopapular
|
22.9%
11/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Vascular disorders
hot flashes
|
6.2%
3/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Vascular disorders
hypertension
|
18.8%
9/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
|
Vascular disorders
hypotension
|
16.7%
8/48 • Reported Adverse Events (AEs) include events starting on or after Day 0 and up to 30 days of receiving the last dose of study medication.
|
Additional Information
Ashraf Badros M.B.Ch.B
University of Maryland Greenebaum Comprehensive Cancer Center
Phone: 410-328-1230
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place