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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd) | Experimental | patients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression. |
|
| Elotuzumab + Nivolumab (EN) | Experimental | Patients will receive treatment with a combination of elotuzumab and nivolumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elotuzumab | Drug |
| ||
| Pomalidomide |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | 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. | From first dose to study completion date (up to approximately 50 months) |
| Objective Response Rate (ORR) | 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. | From first dose to study completion date (up to approximately 50 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 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. | From first dose to study completion date (up to approximately 50 months) |
| Progression Free Survival (PFS) |
Not provided
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:
EN Cohort:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Cancer Center | Mobile | Alabama | 36607 | United States | ||
| Sansum Clinic - USOR |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
Not provided
EPd cohort: 68 participants entered the treatment period. EN cohort: 6 participants entered the treatment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | EPd Cohort | Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle. |
| FG001 | EN Cohort | Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 8, 2018 | Jul 23, 2020 |
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| Drug |
|
| Dexamethasone | Drug |
|
| Nivolumab | Drug |
|
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. |
| From first dose to study completion date (up to approximately 50 months) |
| Overall Survival (OS) | OS is defined as the time from first dosing date to the date of death from any cause. | From first dose to study completion date (up to approximately 50 months) |
| Santa Barbara |
| California |
| 93105 |
| United States |
| Colorado Blood Cancer Institute - PPDS | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer Centers (Williams) - USOR | Denver | Colorado | 80218 | United States |
| Florida Cancer Specialists - EAST - SCRI - PPDS | St. Petersburg | Florida | 33705 | United States |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | St. Petersburg | Florida | 33705 | United States |
| Illinois Cancer Care | Peoria | Illinois | 61615 | United States |
| American Oncology Partners of Maryland, PA | Bethesda | Maryland | 20817 | United States |
| Bay Hematology Oncology | Easton | Maryland | 21601 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Barbara Ann Karmanos Cancer Center | Detroit | Michigan | 48201 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Greenville Health System | Greenville | South Carolina | 29615 | United States |
| Avera Health Care | Sioux Falls | South Dakota | 57105 | United States |
| Jones Clinic PC | Germantown | Tennessee | 38138 | United States |
| Tennessee Oncology NASH - SCRI - PPDS | Nashville | Tennessee | 37203 | United States |
| Texas Oncology (Loop) - USOR | San Antonio | Texas | 78217 | United States |
| Virginia Cancer Specialists (Leesburg) - USOR | Leesburg | Virginia | 20176 | United States |
| Swedish Medical Center | Seattle | Washington | 98104 | United States |
| Cancer Care Northwest | Spokane Valley | Washington | 99216 | United States |
| Aurora Health Care | Burlington | Wisconsin | 53105 | United States |
| FDA Safety Alerts and Recalls | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EPd Cohort | Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle. |
| BG001 | EN Cohort | Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | 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. | All treated participants | Posted | Median | 95% Confidence Interval | Months | From first dose to study completion date (up to approximately 50 months) |
|
|
| |||||||||||||||||||||||||
| Primary | Objective Response Rate (ORR) | 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. | All treated participants | Posted | Number | 95% Confidence Interval | Percent of Participants | From first dose to study completion date (up to approximately 50 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | 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. | All treated participants | Posted | Number | 95% Confidence Interval | Percent of Participants | From first dose to study completion date (up to approximately 50 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | 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. | All treated participants | Posted | Median | 95% Confidence Interval | Months | From first dose to study completion date (up to approximately 50 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as the time from first dosing date to the date of death from any cause. | All treated participants | Posted | Median | 95% Confidence Interval | Months | From first dose to study completion date (up to approximately 50 months) |
|
|
From first dose to 100 days after last dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EPd Cohort | Participants received treatment with Elotuzumab in combination with Pomalidomide and low-dose Dexamethasone in a 28 day cycle. | 32 | 68 | 39 | 68 | 66 | 68 |
| EG001 | EN Cohort | Participants received Elotuzumab in combination with Nivolumab in a 28-day cycle. | 2 | 6 | 3 | 6 | 4 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 23.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | 23.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | 23.0 | Systematic Assessment |
| |
| Amaurosis fugax | Eye disorders | 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 23.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | 23.0 | Systematic Assessment |
| |
| Disease progression | General disorders | 23.0 | Systematic Assessment |
| |
| Sudden death | General disorders | 23.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | 23.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Herpes simplex encephalitis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Salmonella bacteraemia | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Vascular access site bruising | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Influenza B virus test positive | Investigations | 23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 23.0 | Systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.0 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | 23.0 | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | 23.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | 23.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 23.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 23.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 23.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 23.0 | Systematic Assessment |
| |
| Chills | General disorders | 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 23.0 | Systematic Assessment |
| |
| Feeling jittery | General disorders | 23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 23.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 23.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 23.0 | Systematic Assessment |
| |
| Weight increased | Investigations | 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 23.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 23.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 23.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 23.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 23.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 23.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 23.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 23.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 23.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 23.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 23.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | 23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 23.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | 23.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 23.0 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | 23.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 23.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | 23.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 23.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 24, 2018 | Jul 23, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C546027 | elotuzumab |
| C467566 | pomalidomide |
| D003907 | Dexamethasone |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian1 |
|
| Black or African American |
|
| White |
|
| Other |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|