Trial Outcomes & Findings for A Study of Elotuzumab in Combination With Pomalidomide and Low Dose Dexamethasone and Elotuzumab in Combination With Nivolumab in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide. (NCT NCT02612779)
NCT ID: NCT02612779
Last Updated: 2021-07-02
Results Overview
PFS is defined as the time from first dosing date to the date of the first documented progression or death due to any cause, whichever occurs first. Progression is determined per International Myeloma Working Group (IMWG) uniform criteria. Participants who die without a reported prior progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable assessment. Participants who did not have any on study efficacy assessments and did not die were censored on the first dosing date. Participants who switched to subsequent therapy prior to documented progression were censored on the date of the last evaluable assessment prior to the initiation of the new therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
From first dose to study completion date (up to approximately 50 months)
Results posted on
2021-07-02
Participant Flow
EPd cohort: 68 participants entered the treatment period. EN cohort: 6 participants entered the treatment period.
Participant milestones
| Measure |
EPd Cohort
Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle.
|
EN Cohort
Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
68
|
6
|
Reasons for withdrawal
| Measure |
EPd Cohort
Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle.
|
EN Cohort
Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle.
|
|---|---|---|
|
Overall Study
Administrative reason by sponsor
|
4
|
1
|
|
Overall Study
No longer meet study criteria
|
0
|
1
|
|
Overall Study
Disease progression
|
29
|
2
|
|
Overall Study
Study drug toxicity
|
10
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse event unrelated to study drug
|
5
|
0
|
|
Overall Study
Participant withdrew consent
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Maximum clinical benefit
|
10
|
1
|
|
Overall Study
Other reasons
|
4
|
0
|
Baseline Characteristics
A Study of Elotuzumab in Combination With Pomalidomide and Low Dose Dexamethasone and Elotuzumab in Combination With Nivolumab in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.
Baseline characteristics by cohort
| Measure |
EPd Cohort
n=68 Participants
Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle.
|
EN Cohort
n=6 Participants
Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 Years
STANDARD_DEVIATION 9.11 • n=5 Participants
|
69.5 Years
STANDARD_DEVIATION 10.56 • n=7 Participants
|
65.6 Years
STANDARD_DEVIATION 9.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian1
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
58 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose to study completion date (up to approximately 50 months)Population: All treated participants
PFS is defined as the time from first dosing date to the date of the first documented progression or death due to any cause, whichever occurs first. Progression is determined per International Myeloma Working Group (IMWG) uniform criteria. Participants who die without a reported prior progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable assessment. Participants who did not have any on study efficacy assessments and did not die were censored on the first dosing date. Participants who switched to subsequent therapy prior to documented progression were censored on the date of the last evaluable assessment prior to the initiation of the new therapy.
Outcome measures
| Measure |
EPd Cohort
n=68 Participants
Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle.
|
EN Cohort
Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
11.1 Months
Interval 7.4 to 15.0
|
—
|
PRIMARY outcome
Timeframe: From first dose to study completion date (up to approximately 50 months)Population: All treated participants
ORR is defined as the percent of participants with best overall response of partial response (PR) or better. Response is determined per IMWG uniform criteria.
Outcome measures
| Measure |
EPd Cohort
n=6 Participants
Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle.
|
EN Cohort
Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
16.7 Percent of Participants
Interval 0.42 to 64.12
|
—
|
SECONDARY outcome
Timeframe: From first dose to study completion date (up to approximately 50 months)Population: All treated participants
ORR is defined as the percent of participants with best overall response of partial response (PR) or better. Response is determined per IMWG uniform criteria.
Outcome measures
| Measure |
EPd Cohort
n=68 Participants
Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle.
|
EN Cohort
Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
51.5 Percent of Participants
Interval 39.03 to 63.78
|
—
|
SECONDARY outcome
Timeframe: From first dose to study completion date (up to approximately 50 months)Population: All treated participants
PFS is defined as the time from first dosing date to the date of the first documented progression or death due to any cause, whichever occurs first. Progression is determined per International Myeloma Working Group (IMWG) uniform criteria. Participants who die without a reported prior progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable assessment. Participants who did not have any on study efficacy assessments and did not die were censored on the first dosing date. Participants who switched to subsequent therapy prior to documented progression were censored on the date of the last evaluable assessment prior to the initiation of the new therapy.
Outcome measures
| Measure |
EPd Cohort
n=6 Participants
Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle.
|
EN Cohort
Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
1.9 Months
Interval 0.6 to
Upper limit not estimable
|
—
|
SECONDARY outcome
Timeframe: From first dose to study completion date (up to approximately 50 months)Population: All treated participants
OS is defined as the time from first dosing date to the date of death from any cause.
Outcome measures
| Measure |
EPd Cohort
n=68 Participants
Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle.
|
EN Cohort
n=6 Participants
Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle.
|
|---|---|---|
|
Overall Survival (OS)
|
41.2 Months
Interval 22.7 to
Upper limit not estimable
|
NA Months
Interval 0.6 to
The median was not reached because of an insufficient number of events
|
Adverse Events
EPd Cohort
Serious events: 39 serious events
Other events: 66 other events
Deaths: 32 deaths
EN Cohort
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
EPd Cohort
n=68 participants at risk
Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle.
|
EN Cohort
n=6 participants at risk
Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.4%
3/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
2/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Cardiac disorders
Cardiac arrest
|
2.9%
2/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Cardiac disorders
Cardiac failure congestive
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Eye disorders
Amaurosis fugax
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
General disorders
Disease progression
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
General disorders
Sudden death
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Appendicitis perforated
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Cellulitis
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Escherichia sepsis
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Escherichia urinary tract infection
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Herpes simplex encephalitis
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Influenza
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Klebsiella bacteraemia
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Parainfluenzae virus infection
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Pneumonia
|
26.5%
18/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Pneumonia bacterial
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Pulmonary sepsis
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Rhinovirus infection
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Salmonella bacteraemia
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Sepsis
|
4.4%
3/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Septic shock
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Staphylococcal infection
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Urinary tract infection
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Urosepsis
|
2.9%
2/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Injury, poisoning and procedural complications
Femur fracture
|
2.9%
2/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Injury, poisoning and procedural complications
Vascular access site bruising
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Investigations
Influenza B virus test positive
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
2/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
2.9%
2/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Nervous system disorders
Cerebrovascular accident
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Nervous system disorders
Encephalopathy
|
1.5%
1/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Nervous system disorders
Metabolic encephalopathy
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Nervous system disorders
Syncope
|
0.00%
0/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Psychiatric disorders
Mental status changes
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
2/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
2/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.9%
2/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Vascular disorders
Deep vein thrombosis
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Vascular disorders
Hypotension
|
1.5%
1/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
Other adverse events
| Measure |
EPd Cohort
n=68 participants at risk
Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle.
|
EN Cohort
n=6 participants at risk
Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.1%
15/68 • From first dose to 100 days after last dose
|
33.3%
2/6 • From first dose to 100 days after last dose
|
|
Blood and lymphatic system disorders
Leukopenia
|
19.1%
13/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.2%
11/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Blood and lymphatic system disorders
Neutropenia
|
35.3%
24/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.8%
8/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Eye disorders
Cataract
|
7.4%
5/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Eye disorders
Vision blurred
|
7.4%
5/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Gastrointestinal disorders
Abdominal distension
|
2.9%
2/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Gastrointestinal disorders
Constipation
|
25.0%
17/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Gastrointestinal disorders
Diarrhoea
|
35.3%
24/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
4/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Gastrointestinal disorders
Nausea
|
20.6%
14/68 • From first dose to 100 days after last dose
|
33.3%
2/6 • From first dose to 100 days after last dose
|
|
Gastrointestinal disorders
Stomatitis
|
4.4%
3/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Gastrointestinal disorders
Toothache
|
1.5%
1/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Gastrointestinal disorders
Vomiting
|
10.3%
7/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
General disorders
Chills
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
General disorders
Fatigue
|
54.4%
37/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
General disorders
Feeling jittery
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
General disorders
Oedema peripheral
|
25.0%
17/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
General disorders
Pyrexia
|
14.7%
10/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Bronchitis
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Cellulitis
|
8.8%
6/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Conjunctivitis
|
1.5%
1/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
6/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Pneumonia
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Sinusitis
|
7.4%
5/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Infections and infestations
Upper respiratory tract infection
|
36.8%
25/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Injury, poisoning and procedural complications
Fall
|
10.3%
7/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.9%
4/68 • From first dose to 100 days after last dose
|
33.3%
2/6 • From first dose to 100 days after last dose
|
|
Investigations
Neutrophil count decreased
|
10.3%
7/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Investigations
Weight decreased
|
7.4%
5/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Investigations
Weight increased
|
10.3%
7/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.1%
13/68 • From first dose to 100 days after last dose
|
33.3%
2/6 • From first dose to 100 days after last dose
|
|
Metabolism and nutrition disorders
Dehydration
|
10.3%
7/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.7%
10/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.8%
6/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.9%
2/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.2%
9/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.5%
16/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.9%
2/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
17/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.9%
4/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
10.3%
7/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.4%
3/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.8%
6/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Nervous system disorders
Dizziness
|
13.2%
9/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Nervous system disorders
Dysgeusia
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Nervous system disorders
Headache
|
16.2%
11/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Nervous system disorders
Neuropathy peripheral
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.8%
6/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Nervous system disorders
Syncope
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Nervous system disorders
Tremor
|
8.8%
6/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Psychiatric disorders
Anxiety
|
10.3%
7/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Psychiatric disorders
Depression
|
10.3%
7/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Psychiatric disorders
Insomnia
|
20.6%
14/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Renal and urinary disorders
Dysuria
|
7.4%
5/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
32.4%
22/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
26.5%
18/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.4%
5/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.4%
5/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
1/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.4%
5/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.4%
5/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
8.8%
6/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.3%
7/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
2.9%
2/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.3%
7/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Vascular disorders
Deep vein thrombosis
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Vascular disorders
Flushing
|
5.9%
4/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
|
Vascular disorders
Hot flush
|
5.9%
4/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Vascular disorders
Hypertension
|
11.8%
8/68 • From first dose to 100 days after last dose
|
0.00%
0/6 • From first dose to 100 days after last dose
|
|
Vascular disorders
Hypotension
|
2.9%
2/68 • From first dose to 100 days after last dose
|
16.7%
1/6 • From first dose to 100 days after last dose
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER