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.
Study Details
Study Description
Brief Summary
Study of elotuzumab in combination with pomalidomide and low dose dexamethasone (EPd Cohort) and elotuzumab in combination with nivolumab (EN Cohort) to assess the safety and efficacy of these combination therapies for treatment of relapsed or refractory MM patients.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd) patients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression. |
Drug: Elotuzumab
Drug: Pomalidomide
Drug: Dexamethasone
Drug: Nivolumab
|
Experimental: Elotuzumab + Nivolumab (EN) Patients will receive treatment with a combination of elotuzumab and nivolumab |
Drug: Elotuzumab
Drug: Nivolumab
|
Outcome Measures
Primary Outcome Measures
- Progression Free Survival (PFS) [From first dose to study completion date (up to approximately 50 months)]
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.
- Objective Response Rate (ORR) [From first dose to study completion date (up to approximately 50 months)]
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.
Secondary Outcome Measures
- Objective Response Rate (ORR) [From first dose to study completion date (up to approximately 50 months)]
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.
- Progression Free Survival (PFS) [From first dose to study completion date (up to approximately 50 months)]
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.
- Overall Survival (OS) [From first dose to study completion date (up to approximately 50 months)]
OS is defined as the time from first dosing date to the date of death from any cause.
Eligibility Criteria
Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
-
All subjects must have documented disease progression per IMWG criteria during or after their last anti-myeloma therapy.
-
ECOG Performance Status less than or equal to 2
-
Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (ie, has not been treated). If re-enrolled, the subject must be re-consented.
-
EPd Cohort:
-
must have received at least 1 but no greater than 2 prior lines of therapy (note: induction and stem cell transplants with or without maintenance therapy is considered 1 line of therapy)
-
Subjects must have received prior treatment with a lenalidomide-containing regimen for at least 2 consecutive cycles (full therapeutic dose) and must have been deemed as relapsed, refractory, or intolerant. Refractory is defined as progressing on-treatment or within 60 days of the last dose.
- EN Cohort:
- Subjects must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent OR were double-refractory to both an IMID and a PI. Refractory is defined as progressing on-treatment or within 60 days of the last dose.
Exclusion Criteria:
-
Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cells dyscrasia
-
Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with poly neuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
-
Subjects with Central Nervous System involvement with multiple myeloma
Other protocol defined inclusion/exclusion criteria could apply.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Southern Cancer Center | Mobile | Alabama | United States | 36607 |
2 | Sansum Clinic - USOR | Santa Barbara | California | United States | 93105 |
3 | Colorado Blood Cancer Institute - PPDS | Denver | Colorado | United States | 80218 |
4 | Rocky Mountain Cancer Centers (Williams) - USOR | Denver | Colorado | United States | 80218 |
5 | Florida Cancer Specialists - EAST - SCRI - PPDS | Saint Petersburg | Florida | United States | 33705 |
6 | Florida Cancer Specialists - NORTH - SCRI - PPDS | Saint Petersburg | Florida | United States | 33705 |
7 | Illinois Cancer Care | Peoria | Illinois | United States | 61615 |
8 | American Oncology Partners of Maryland, PA | Bethesda | Maryland | United States | 20817 |
9 | Bay Hematology Oncology | Easton | Maryland | United States | 21601 |
10 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
11 | Barbara Ann Karmanos Cancer Center | Detroit | Michigan | United States | 48201 |
12 | Washington University | Saint Louis | Missouri | United States | 63110 |
13 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
14 | Greenville Health System | Greenville | South Carolina | United States | 29615 |
15 | Avera Health Care | Sioux Falls | South Dakota | United States | 57105 |
16 | Jones Clinic PC | Germantown | Tennessee | United States | 38138 |
17 | Tennessee Oncology NASH - SCRI - PPDS | Nashville | Tennessee | United States | 37203 |
18 | Texas Oncology (Loop) - USOR | San Antonio | Texas | United States | 78217 |
19 | Virginia Cancer Specialists (Leesburg) - USOR | Leesburg | Virginia | United States | 20176 |
20 | Swedish Medical Center | Seattle | Washington | United States | 98104 |
21 | Cancer Care Northwest | Spokane Valley | Washington | United States | 99216 |
22 | Aurora Health Care | Burlington | Wisconsin | United States | 53105 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- CA204-142
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | EPd cohort: 68 participants entered the treatment period. EN cohort: 6 participants entered the treatment period. |
Arm/Group Title | EPd Cohort | EN Cohort |
---|---|---|
Arm/Group Description | Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle. | Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle. |
Period Title: Overall Study | ||
STARTED | 68 | 6 |
COMPLETED | 0 | 0 |
NOT COMPLETED | 68 | 6 |
Baseline Characteristics
Arm/Group Title | EPd Cohort | EN Cohort | Total |
---|---|---|---|
Arm/Group Description | Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle. | Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle. | Total of all reporting groups |
Overall Participants | 68 | 6 | 74 |
Age (Years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [Years] |
65.3
(9.11)
|
69.5
(10.56)
|
65.6
(9.23)
|
Sex: Female, Male (Count of Participants) | |||
Female |
33
48.5%
|
3
50%
|
36
48.6%
|
Male |
35
51.5%
|
3
50%
|
38
51.4%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
6
8.8%
|
0
0%
|
6
8.1%
|
Not Hispanic or Latino |
61
89.7%
|
6
100%
|
67
90.5%
|
Unknown or Not Reported |
1
1.5%
|
0
0%
|
1
1.4%
|
Race/Ethnicity, Customized (Count of Participants) | |||
American Indian or Alaska Native |
1
1.5%
|
0
0%
|
1
1.4%
|
Asian1 |
1
1.5%
|
0
0%
|
1
1.4%
|
Black or African American |
4
5.9%
|
3
50%
|
7
9.5%
|
White |
58
85.3%
|
3
50%
|
61
82.4%
|
Other |
4
5.9%
|
0
0%
|
4
5.4%
|
Outcome Measures
Title | Progression Free Survival (PFS) |
---|---|
Description | 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. |
Time Frame | From first dose to study completion date (up to approximately 50 months) |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | EPd Cohort |
---|---|
Arm/Group Description | Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle. |
Measure Participants | 68 |
Median (95% Confidence Interval) [Months] |
11.1
|
Title | Objective Response Rate (ORR) |
---|---|
Description | 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. |
Time Frame | From first dose to study completion date (up to approximately 50 months) |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | EN Cohort |
---|---|
Arm/Group Description | Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle. |
Measure Participants | 6 |
Number (95% Confidence Interval) [Percent of Participants] |
16.7
24.6%
|
Title | Objective Response Rate (ORR) |
---|---|
Description | 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. |
Time Frame | From first dose to study completion date (up to approximately 50 months) |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | EPd Cohort |
---|---|
Arm/Group Description | Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle. |
Measure Participants | 68 |
Number (95% Confidence Interval) [Percent of Participants] |
51.5
75.7%
|
Title | Progression Free Survival (PFS) |
---|---|
Description | 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. |
Time Frame | From first dose to study completion date (up to approximately 50 months) |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | EN Cohort |
---|---|
Arm/Group Description | Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle. |
Measure Participants | 6 |
Median (95% Confidence Interval) [Months] |
1.9
|
Title | Overall Survival (OS) |
---|---|
Description | OS is defined as the time from first dosing date to the date of death from any cause. |
Time Frame | From first dose to study completion date (up to approximately 50 months) |
Outcome Measure Data
Analysis Population Description |
---|
All treated participants |
Arm/Group Title | EPd Cohort | EN Cohort |
---|---|---|
Arm/Group Description | Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle. | Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle. |
Measure Participants | 68 | 6 |
Median (95% Confidence Interval) [Months] |
41.2
|
NA
|
Adverse Events
Time Frame | From first dose to 100 days after last dose | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | EPd Cohort | EN Cohort | ||
Arm/Group Description | Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle. | Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle. | ||
All Cause Mortality |
||||
EPd Cohort | EN Cohort | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 32/68 (47.1%) | 2/6 (33.3%) | ||
Serious Adverse Events |
||||
EPd Cohort | EN Cohort | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 39/68 (57.4%) | 3/6 (50%) | ||
Blood and lymphatic system disorders | ||||
Febrile neutropenia | 3/68 (4.4%) | 0/6 (0%) | ||
Neutropenia | 1/68 (1.5%) | 0/6 (0%) | ||
Cardiac disorders | ||||
Atrial fibrillation | 2/68 (2.9%) | 0/6 (0%) | ||
Cardiac arrest | 2/68 (2.9%) | 0/6 (0%) | ||
Cardiac failure congestive | 1/68 (1.5%) | 0/6 (0%) | ||
Eye disorders | ||||
Amaurosis fugax | 1/68 (1.5%) | 0/6 (0%) | ||
Gastrointestinal disorders | ||||
Diarrhoea | 1/68 (1.5%) | 0/6 (0%) | ||
Rectal haemorrhage | 1/68 (1.5%) | 0/6 (0%) | ||
General disorders | ||||
Disease progression | 1/68 (1.5%) | 0/6 (0%) | ||
Sudden death | 1/68 (1.5%) | 0/6 (0%) | ||
Systemic inflammatory response syndrome | 0/68 (0%) | 1/6 (16.7%) | ||
Infections and infestations | ||||
Appendicitis perforated | 1/68 (1.5%) | 0/6 (0%) | ||
Bacteraemia | 0/68 (0%) | 1/6 (16.7%) | ||
Cellulitis | 4/68 (5.9%) | 0/6 (0%) | ||
Escherichia sepsis | 1/68 (1.5%) | 0/6 (0%) | ||
Escherichia urinary tract infection | 1/68 (1.5%) | 0/6 (0%) | ||
Herpes simplex encephalitis | 1/68 (1.5%) | 0/6 (0%) | ||
Influenza | 1/68 (1.5%) | 0/6 (0%) | ||
Klebsiella bacteraemia | 1/68 (1.5%) | 0/6 (0%) | ||
Parainfluenzae virus infection | 1/68 (1.5%) | 0/6 (0%) | ||
Pneumonia | 18/68 (26.5%) | 0/6 (0%) | ||
Pneumonia bacterial | 1/68 (1.5%) | 0/6 (0%) | ||
Pulmonary sepsis | 1/68 (1.5%) | 0/6 (0%) | ||
Rhinovirus infection | 1/68 (1.5%) | 0/6 (0%) | ||
Salmonella bacteraemia | 1/68 (1.5%) | 0/6 (0%) | ||
Sepsis | 3/68 (4.4%) | 0/6 (0%) | ||
Septic shock | 1/68 (1.5%) | 0/6 (0%) | ||
Staphylococcal infection | 1/68 (1.5%) | 0/6 (0%) | ||
Upper respiratory tract infection | 1/68 (1.5%) | 0/6 (0%) | ||
Urinary tract infection | 4/68 (5.9%) | 0/6 (0%) | ||
Urosepsis | 2/68 (2.9%) | 0/6 (0%) | ||
Injury, poisoning and procedural complications | ||||
Fall | 1/68 (1.5%) | 0/6 (0%) | ||
Femur fracture | 2/68 (2.9%) | 0/6 (0%) | ||
Hip fracture | 1/68 (1.5%) | 0/6 (0%) | ||
Lumbar vertebral fracture | 1/68 (1.5%) | 0/6 (0%) | ||
Vascular access site bruising | 1/68 (1.5%) | 0/6 (0%) | ||
Investigations | ||||
Influenza B virus test positive | 1/68 (1.5%) | 0/6 (0%) | ||
Metabolism and nutrition disorders | ||||
Dehydration | 2/68 (2.9%) | 0/6 (0%) | ||
Diabetic ketoacidosis | 1/68 (1.5%) | 0/6 (0%) | ||
Failure to thrive | 1/68 (1.5%) | 0/6 (0%) | ||
Hypercalcaemia | 1/68 (1.5%) | 0/6 (0%) | ||
Musculoskeletal and connective tissue disorders | ||||
Muscular weakness | 1/68 (1.5%) | 0/6 (0%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Clear cell renal cell carcinoma | 1/68 (1.5%) | 0/6 (0%) | ||
Malignant neoplasm progression | 2/68 (2.9%) | 1/6 (16.7%) | ||
Nervous system disorders | ||||
Cerebrovascular accident | 1/68 (1.5%) | 0/6 (0%) | ||
Encephalopathy | 1/68 (1.5%) | 1/6 (16.7%) | ||
Metabolic encephalopathy | 1/68 (1.5%) | 0/6 (0%) | ||
Syncope | 0/68 (0%) | 1/6 (16.7%) | ||
Psychiatric disorders | ||||
Mental status changes | 1/68 (1.5%) | 0/6 (0%) | ||
Renal and urinary disorders | ||||
Acute kidney injury | 2/68 (2.9%) | 0/6 (0%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Dyspnoea | 1/68 (1.5%) | 0/6 (0%) | ||
Hypoxia | 1/68 (1.5%) | 0/6 (0%) | ||
Pleural effusion | 1/68 (1.5%) | 0/6 (0%) | ||
Pneumonia aspiration | 1/68 (1.5%) | 0/6 (0%) | ||
Pneumonitis | 2/68 (2.9%) | 0/6 (0%) | ||
Pulmonary embolism | 2/68 (2.9%) | 0/6 (0%) | ||
Respiratory failure | 1/68 (1.5%) | 0/6 (0%) | ||
Vascular disorders | ||||
Deep vein thrombosis | 1/68 (1.5%) | 0/6 (0%) | ||
Hypotension | 1/68 (1.5%) | 0/6 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
EPd Cohort | EN Cohort | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 66/68 (97.1%) | 4/6 (66.7%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 15/68 (22.1%) | 2/6 (33.3%) | ||
Leukopenia | 13/68 (19.1%) | 0/6 (0%) | ||
Lymphopenia | 11/68 (16.2%) | 1/6 (16.7%) | ||
Neutropenia | 24/68 (35.3%) | 0/6 (0%) | ||
Thrombocytopenia | 8/68 (11.8%) | 1/6 (16.7%) | ||
Eye disorders | ||||
Cataract | 5/68 (7.4%) | 0/6 (0%) | ||
Conjunctival hyperaemia | 0/68 (0%) | 1/6 (16.7%) | ||
Vision blurred | 5/68 (7.4%) | 0/6 (0%) | ||
Gastrointestinal disorders | ||||
Abdominal distension | 2/68 (2.9%) | 1/6 (16.7%) | ||
Constipation | 17/68 (25%) | 1/6 (16.7%) | ||
Diarrhoea | 24/68 (35.3%) | 0/6 (0%) | ||
Dyspepsia | 4/68 (5.9%) | 1/6 (16.7%) | ||
Nausea | 14/68 (20.6%) | 2/6 (33.3%) | ||
Stomatitis | 3/68 (4.4%) | 1/6 (16.7%) | ||
Toothache | 1/68 (1.5%) | 1/6 (16.7%) | ||
Vomiting | 7/68 (10.3%) | 0/6 (0%) | ||
General disorders | ||||
Chills | 4/68 (5.9%) | 0/6 (0%) | ||
Fatigue | 37/68 (54.4%) | 1/6 (16.7%) | ||
Feeling jittery | 4/68 (5.9%) | 0/6 (0%) | ||
Oedema peripheral | 17/68 (25%) | 0/6 (0%) | ||
Pyrexia | 10/68 (14.7%) | 1/6 (16.7%) | ||
Infections and infestations | ||||
Bronchitis | 4/68 (5.9%) | 0/6 (0%) | ||
Cellulitis | 6/68 (8.8%) | 0/6 (0%) | ||
Conjunctivitis | 1/68 (1.5%) | 1/6 (16.7%) | ||
Lower respiratory tract infection | 0/68 (0%) | 1/6 (16.7%) | ||
Nasopharyngitis | 6/68 (8.8%) | 0/6 (0%) | ||
Pneumonia | 4/68 (5.9%) | 0/6 (0%) | ||
Sinusitis | 5/68 (7.4%) | 0/6 (0%) | ||
Upper respiratory tract infection | 25/68 (36.8%) | 0/6 (0%) | ||
Injury, poisoning and procedural complications | ||||
Contusion | 4/68 (5.9%) | 0/6 (0%) | ||
Fall | 7/68 (10.3%) | 0/6 (0%) | ||
Infusion related reaction | 4/68 (5.9%) | 2/6 (33.3%) | ||
Investigations | ||||
Neutrophil count decreased | 7/68 (10.3%) | 0/6 (0%) | ||
Weight decreased | 5/68 (7.4%) | 0/6 (0%) | ||
Weight increased | 7/68 (10.3%) | 0/6 (0%) | ||
Metabolism and nutrition disorders | ||||
Decreased appetite | 13/68 (19.1%) | 2/6 (33.3%) | ||
Dehydration | 7/68 (10.3%) | 0/6 (0%) | ||
Diabetes mellitus | 4/68 (5.9%) | 0/6 (0%) | ||
Hyperglycaemia | 10/68 (14.7%) | 0/6 (0%) | ||
Hypocalcaemia | 4/68 (5.9%) | 0/6 (0%) | ||
Hypokalaemia | 6/68 (8.8%) | 0/6 (0%) | ||
Hypomagnesaemia | 2/68 (2.9%) | 1/6 (16.7%) | ||
Hyponatraemia | 4/68 (5.9%) | 0/6 (0%) | ||
Hypophosphataemia | 4/68 (5.9%) | 0/6 (0%) | ||
Musculoskeletal and connective tissue disorders | ||||
Arthralgia | 9/68 (13.2%) | 1/6 (16.7%) | ||
Back pain | 16/68 (23.5%) | 0/6 (0%) | ||
Bone pain | 2/68 (2.9%) | 1/6 (16.7%) | ||
Muscle spasms | 17/68 (25%) | 1/6 (16.7%) | ||
Muscular weakness | 4/68 (5.9%) | 1/6 (16.7%) | ||
Musculoskeletal chest pain | 7/68 (10.3%) | 0/6 (0%) | ||
Myalgia | 3/68 (4.4%) | 1/6 (16.7%) | ||
Neck pain | 0/68 (0%) | 1/6 (16.7%) | ||
Pain in extremity | 6/68 (8.8%) | 0/6 (0%) | ||
Nervous system disorders | ||||
Dizziness | 9/68 (13.2%) | 1/6 (16.7%) | ||
Dysgeusia | 4/68 (5.9%) | 0/6 (0%) | ||
Headache | 11/68 (16.2%) | 1/6 (16.7%) | ||
Hypoaesthesia | 4/68 (5.9%) | 0/6 (0%) | ||
Neuropathy peripheral | 4/68 (5.9%) | 0/6 (0%) | ||
Peripheral sensory neuropathy | 6/68 (8.8%) | 0/6 (0%) | ||
Syncope | 4/68 (5.9%) | 0/6 (0%) | ||
Tremor | 6/68 (8.8%) | 0/6 (0%) | ||
Psychiatric disorders | ||||
Anxiety | 7/68 (10.3%) | 0/6 (0%) | ||
Depression | 7/68 (10.3%) | 0/6 (0%) | ||
Insomnia | 14/68 (20.6%) | 1/6 (16.7%) | ||
Renal and urinary disorders | ||||
Dysuria | 5/68 (7.4%) | 0/6 (0%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Cough | 22/68 (32.4%) | 1/6 (16.7%) | ||
Dyspnoea | 18/68 (26.5%) | 0/6 (0%) | ||
Dyspnoea exertional | 5/68 (7.4%) | 0/6 (0%) | ||
Nasal congestion | 5/68 (7.4%) | 0/6 (0%) | ||
Pneumonitis | 1/68 (1.5%) | 1/6 (16.7%) | ||
Productive cough | 5/68 (7.4%) | 0/6 (0%) | ||
Rhinorrhoea | 4/68 (5.9%) | 0/6 (0%) | ||
Skin and subcutaneous tissue disorders | ||||
Alopecia | 4/68 (5.9%) | 0/6 (0%) | ||
Hyperhidrosis | 5/68 (7.4%) | 1/6 (16.7%) | ||
Night sweats | 6/68 (8.8%) | 0/6 (0%) | ||
Pruritus | 7/68 (10.3%) | 1/6 (16.7%) | ||
Rash macular | 2/68 (2.9%) | 1/6 (16.7%) | ||
Rash maculo-papular | 7/68 (10.3%) | 0/6 (0%) | ||
Skin fissures | 0/68 (0%) | 1/6 (16.7%) | ||
Vascular disorders | ||||
Deep vein thrombosis | 4/68 (5.9%) | 0/6 (0%) | ||
Flushing | 4/68 (5.9%) | 1/6 (16.7%) | ||
Hot flush | 4/68 (5.9%) | 0/6 (0%) | ||
Hypertension | 8/68 (11.8%) | 0/6 (0%) | ||
Hypotension | 2/68 (2.9%) | 1/6 (16.7%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Bristol-Myers Squibb Study Director |
---|---|
Organization | Bristol-Myers Squibb |
Phone | Please email |
Clinical.Trials@bms.com |
- CA204-142