Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003282-19 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Celgene | INDUSTRY |
| AbbVie | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma compared to pomalidomide and low-dose dexamethasone by itself.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elotuzumab Arm | Experimental | Biological:Elotuzumab (BMS-901608; HuLuc63)
Drug: Pomalidomide •Capsules,Oral,4 mg,once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone
Other Names: Decadron,Dexamethasone ,Intensol,Dexpak,Taperpak |
|
| Control Arm | Active Comparator | Drug: Pomalidomide • Capsules, Oral, 4 mg, once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone Subjects ≤ 75 years old: • Tablets, Oral, 40 mg, weekly on Days 1, 8, 15 and 22 Subjects > 75 years old: • Tablets, Oral, 20 mg, weekly on Days 1, 8, 15 and 22, Other Names:
|
|
| 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 randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following: 1. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder | From randomization to date of progression or death (up to approximately 21 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment
|
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winship Cancer Institute | Atlanta | Georgia | 30322 | United States | ||
| Rush University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35960908 | Derived | Dimopoulos MA, Dytfeld D, Grosicki S, Moreau P, Takezako N, Hori M, Leleu X, LeBlanc R, Suzuki K, Raab MS, Richardson PG, Popa McKiver M, Jou YM, Yao D, Das P, San-Miguel J. Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed/Refractory Multiple Myeloma: Final Overall Survival Analysis From the Randomized Phase II ELOQUENT-3 Trial. J Clin Oncol. 2023 Jan 20;41(3):568-578. doi: 10.1200/JCO.21.02815. Epub 2022 Aug 12. | |
| 30403938 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
117 participants were randomized, and 115 participants were treated.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | E-Pd Cohort | Elotuzumab + Pomalidomide + Dexamethasone |
| FG001 | Pd Cohort | Pomalidomide + Dexamethasone |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Pre-Treatment Period |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 11, 2015 | Jan 17, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Dexamethasone | Drug |
|
|
| From first dose to disease progression (up to approximately 21 months) |
| Overall Survival (OS) | OS is the time from randomization to the date of death from any cause. The survival time for participants who had not died was censored at the last known alive date. OS was censored at the date of randomization for subjects who were randomized but had no follow-up. | From randomization to death (up to approximately 52 months) |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Investigative Clinical Research Of Indiana, Llc | Indianapolis | Indiana | 46260 | United States |
| Beth Israel Comprehensive Cancer Center | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute. | Boston | Massachusetts | 02215 | United States |
| Rochester General Hospital | Rochester | New York | 14621 | United States |
| Carolinas Healthcare System | Charlotte | North Carolina | 28204 | United States |
| Va Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | 15240 | United States |
| St Francis Hospital | Greenville | South Carolina | 29607 | United States |
| Tennessee Cancer Specialists | Knoxville | Tennessee | 37909 | United States |
| Northern Utah Associates | Ogden | Utah | 84403 | United States |
| University Of Washington | Seattle | Washington | 98109 | United States |
| Local Institution | South Brisbane | Queensland | 4101 | Australia |
| Local Institution | London | Ontario | N6A 4G5 | Canada |
| CISSS de l'Outaouais | Gatineau | Quebec | J8P 7H2 | Canada |
| Local Institution - 0048 | Montreal | Quebec | H1T 2M4 | Canada |
| Local Institution - 0022 | Nantes | 44000 | France |
| Local Institution - 0021 | Paris | 75571 | France |
| Local Institution - 0020 | Pessac | 33604 | France |
| Local Institution - 0019 | Poitiers | 86021 | France |
| Local Institution | Saint-Pierre | 97448 | France |
| Universitaetsklinikum Carl Gustav Carus | Dresden | 01307 | Germany |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| St. Barbara-Klinik | Hamm | 59075 | Germany |
| Local Institution - 0041 | Heidelberg | 69120 | Germany |
| Local Institution - 0056 | Kiel | 24105 | Germany |
| Klinikum Der Johannes Gutenberg Universitaet Mainz | Mainz | 55101 | Germany |
| Universitaetsklinikum Tuebingen | Tübingen | 72076 | Germany |
| Laiko University Hospital | Athens | 11527 | Greece |
| Alexandra General Hospital Of Athens | Athens | 11528 | Greece |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona | Ancona | 60126 | Italy |
| A. O. U. Di Bologna, Policlinico S. Orsola Malpighi | Bologna | 40138 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50134 | Italy |
| Local Institution | Roma | 00144 | Italy |
| Universita' La Sapienza | Roma | 00161 | Italy |
| Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino | Torino | 10126 | Italy |
| Local Institution - 0030 | Nagoya | Aichi-ken | 4678602 | Japan |
| Local Institution - 0069 | Morioka | Iwate | 0208505 | Japan |
| Local Institution - 0031 | Kyoto | Kyoto | 6028566 | Japan |
| Local Institution - 0029 | Niigata | Niigata | 951-8566 | Japan |
| Local Institution - 0027 | Shibuya-ku | Tokyo | 1508935 | Japan |
| Local Institution - 0028 | Tachikawa-shi | Tokyo | 1900014 | Japan |
| Local Institution - 0067 | Kasama-shi | 3091793 | Japan |
| Local Institution - 0032 | Okayama | 701-1154 | Japan |
| Local Institution | Amsterdam | 1081 HV | Netherlands |
| Local Institution | Groningen | 9713 GZ | Netherlands |
| Local Institution | Maastrict | 6229 HX | Netherlands |
| Local Institution | Utrecht | 3584 CX | Netherlands |
| Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych | Chorzów | 41-500 | Poland |
| Local Institution | Lublin | 20-090 | Poland |
| Oddzial Hematologii i Transplantacji Szpiku | Poznan | 60-569 | Poland |
| Local Institution | Pamplona | Navarre | 31008 | Spain |
| Local Institution | Barcelona | 08025 | Spain |
| Local Institution - 0024 | Madrid | 28041 | Spain |
| Local Institution | Valencia | 46017 | Spain |
| Derived |
| Dimopoulos MA, Dytfeld D, Grosicki S, Moreau P, Takezako N, Hori M, Leleu X, LeBlanc R, Suzuki K, Raab MS, Richardson PG, Popa McKiver M, Jou YM, Shelat SG, Robbins M, Rafferty B, San-Miguel J. Elotuzumab plus Pomalidomide and Dexamethasone for Multiple Myeloma. N Engl J Med. 2018 Nov 8;379(19):1811-1822. doi: 10.1056/NEJMoa1805762. |
| BMS Clinical Trial Patient Recruiting | View source |
|
| COMPLETED | Completed = Continued into Treatment Period |
|
| NOT COMPLETED |
|
|
| Treatment Period |
|
|
All randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | E-Pd Cohort | Elotuzumab + Pomalidomide + Dexamethasone |
| BG001 | Pd Cohort | Pomalidomide + Dexamethasone |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | All treated participants | Count of Participants | Participants |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | All treated participants | 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 randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following: 1. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder | All randomized participants | Posted | Median | 95% Confidence Interval | Months | From randomization to date of progression or death (up to approximately 21 months) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR is defined as the percentage of participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment
| All randomized participants | Posted | Number | 95% Confidence Interval | Percent of participants | From first dose to disease progression (up to approximately 21 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is the time from randomization to the date of death from any cause. The survival time for participants who had not died was censored at the last known alive date. OS was censored at the date of randomization for subjects who were randomized but had no follow-up. | All randomized participants | Posted | Median | 95% Confidence Interval | Months | From randomization to death (up to approximately 52 months) |
|
|
All-cause mortality: from randomization to study completion (up to approximately 67 months) SAEs and Other Adverse Events: from first dose to 60 days following last dose (up to approximately 60 months)
All-cause mortality: all randomized participants SAEs and Other Adverse Events: all treated participants
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | E-Pd Cohort | Elotuzumab + Pomalidomide + Dexamethasone | 41 | 60 | 42 | 60 | 56 | 60 |
| EG001 | Pd Cohort | Pomalidomide + Dexamethasone | 41 | 57 | 33 | 55 | 49 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 24.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | 24.1 | Systematic Assessment |
| |
| Cataract subcapsular | Eye disorders | 24.1 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Disease progression | General disorders | 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 24.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | 24.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | 24.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.1 | Systematic Assessment |
| |
| Sudden death | General disorders | 24.1 | Systematic Assessment |
| |
| Primary amyloidosis | Immune system disorders | 24.1 | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Systemic infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | 24.1 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Invasive breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Plasma cell leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Prostate cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Haemorrhagic transformation stroke | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 24.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 24.1 | Systematic Assessment |
| |
| Bladder prolapse | Renal and urinary disorders | 24.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 24.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 24.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 24.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 24.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 24.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 24.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 24.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 24.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | 24.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 24.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 24.1 | 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 | May 1, 2018 | Feb 20, 2019 | 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 |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
Not provided
Not provided
| Other reasons |
|
| Study drug toxicity |
|
| Withdrawal by Subject |
|
| Maximum Clinical Benefit |
|
| Participant request to discontinue |
|
| Administrative reasons by sponsor |
|
| Death |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|