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.

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT02612779
Collaborator
(none)
74
22
2
52.1
3.4
0.1

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

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multiple Cohort Study of Elotuzumab in Combination With Pomalidomide and Low-Dose Dexamethasone (EPd), and in Combination With Nivolumab (EN), in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.
Actual Study Start Date :
Feb 9, 2016
Actual Primary Completion Date :
Jul 29, 2019
Actual Study Completion Date :
Jun 12, 2020

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

  1. 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.

  2. 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

  1. 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.

  2. 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.

  3. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:
  1. All subjects must have documented disease progression per IMWG criteria during or after their last anti-myeloma therapy.

  2. ECOG Performance Status less than or equal to 2

  3. 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.

  4. 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.

  1. 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:
  1. Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cells dyscrasia

  2. 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)

  3. 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.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02612779
Other Study ID Numbers:
  • CA204-142
First Posted:
Nov 24, 2015
Last Update Posted:
Jul 2, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

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

1. Primary Outcome
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
2. Primary Outcome
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%
3. Secondary Outcome
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%
4. Secondary Outcome
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
5. Secondary Outcome
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

[Not Specified]

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
Email Clinical.Trials@bms.com
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02612779
Other Study ID Numbers:
  • CA204-142
First Posted:
Nov 24, 2015
Last Update Posted:
Jul 2, 2021
Last Verified:
Jun 1, 2021