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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022445-20 | EudraCT Number |
Not provided
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Insufficient enrollment
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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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The purpose of the study is to look at subjects who receive Lenalidomide, Dexamethasone, and Elotuzumab and determine if they will have lower surface CS1 expression on malignant plasma cells at the time of progression than those who receive Lenalidomide and Dexamethasone without Elotuzumab
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Lenalidomide + Dexamethasone | Experimental | Lenalidomide 25 mg capsules by mouth once daily (on Days 1-21), repeat every 28 days until subject meets criteria for discontinuation of study drug Dexamethasone 40 mg tablets by mouth weekly (on Days 1, 8, 15, 22), repeat every 28 days until subject meets criteria for discontinuation of study drug |
|
| Arm 2: Lenalidomide + Dexamethasone + Elotuzumab | Experimental | Lenalidomide 25 mg capsules by mouth once daily (Days 1-21) Dexamethasone 28 mg tablets by mouth once daily [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15(cycles 3-18); Day 1 (cycle 19 & beyond)] Dexamethasone 40 mg tablets by mouth once daily [Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 & beyond)] Dexamethasone 8 mg IV (intravenous) solution once daily [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15 (cycles 3-18); Day 1 (cycle 19 & beyond)] Elotuzumab 10 mg/kg IV solution weekly [Days 1, 8, 15, 22 (cycles 1 & 2); Days 1 & 15 (cycles 3-18)] Elotuzumab 20 mg/kg IV solution on Day 1 (cycle 19 & beyond) Repeat above-mentioned dose cycles every 28 days until subject meets criteria for discontinuation of study drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Progression of the Cell Surface Expression of CS1 From Bone Marrow-Derived Multiple Myeloma (MM) Cells | CS1 (CD2 subset-1, also known as CRACC, SLAMF7, CD319) expression levels in multiple myeloma cells were analyzed from bone-marrow aspirates collected at baseline and at time of progression through mean fluorescent intensity. The following conditions were considered to describe multiple myeloma cells expressing CS1 (CS1+/CD38++/CD138+/CD56+/CD19-/CD45DIM) | From baseline (screening) to time of progression (up to approximately 54 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Bone Marrow-Derived Multiple Myeloma (MM) Cells Expressing Cell Surface CS1 at Time of Progression | CS1 (CD2 subset-1, also known as CRACC, SLAMF7, CD319) expression levels in multiple myeloma cells were analyzed from bone-marrow aspirates collected at time of progression. The following conditions were considered to describe multiple myeloma cells expressing CS1 (CS1+/CD38++/CD138+/CD56+/CD19-/CD45DIM) |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Subjects who are newly diagnosed with symptomatic MM and who:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Hematology Oncology Associates | San Francisco | California | 94115 | United States | ||
| Memorial Cancer Institute |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
| BMS Clinical Trial Patient Recruiting |
Not provided
23 participants treated in the main CA204-006 study (NCT01335399) were recruited for the CA204-006 biomarker sub-study (NCT01891643).
No additional treatment (other than what administered in the main study) was dosed during the biomarker sub-study.
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| ID | Title | Description |
|---|---|---|
| FG000 | E-Ld Cohort | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle |
| FG001 | Ld Cohort | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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 | Feb 19, 2013 | Jun 29, 2021 |
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| Dexamethasone | Drug |
|
|
| Elotuzumab | Biological |
|
|
| Time of progression (up to approximately 54 months from pre-treatment screening) |
| Levels of CS1 Soluble Form (sCS1) in Serum | Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection | At baseline (screening), during main study therapy (cycle 3 day 1, up to 64 days) and at time of progression (up to approximately 31 months) |
| Change From Baseline in the Levels of CS1 Soluble Form (sCS1) in Serum During Therapy and At Progression | Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection | From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to time of progression (up to approximately 31 months) |
| Change From Baseline in the Number of Circulating Multiple Myeloma (MM) Cells | Circulating MM cells isolated from peripheral blood | From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to the time of progression (up to approximately 54 months) |
| Change From Baseline in Cell Surface CS1 Expression Levels in Circulating Multiple Myeloma (MM) Cells | Circulating MM cells isolated from peripheral blood | From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to the time of progression (up to approximately 54 months) |
| CS1 Expression Levels in Matched Samples of Bone Marrow-Derived Multiple Myeloma (MM) Cells and Circulating MM Cells | CS1 expression levels analyzed from matching bone marrow aspirates (for bone marrow-derived MM cells) and from peripheral blood (for circulating tumor cells) collected from the same participants | At baseline (screening), during main study therapy (cycle 3 day 1) and at time of progression (up to approximately 54 months) |
| Hollywood |
| Florida |
| 33021 |
| United States |
| Illinois Cancercare, Pc | Peoria | Illinois | 61615 | United States |
| Franciscan St. Francis Health | Indianapolis | Indiana | 46237 | United States |
| Crescent City Research Consortium, LLC | Marrero | Louisiana | 70072 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Medical University Of South Carolina Hollings Cancer Center | Charleston | South Carolina | 29425 | United States |
| Baptist Cancer Center | Memphis | Tennessee | 38120 | United States |
| Northern Utah Associates | Ogden | Utah | 84405 | United States |
| Local Institution | Athens | 11528 | Greece |
| Local Institution | Genova | 16132 | Italy |
| Local Institution | Rome | 00161 | Italy |
| Local Institution | Chorzów | 41-500 | Poland |
| Local Institution | Lublin | 20-081 | Poland |
| COMPLETED | Completed = continuing treatment in the main CA204-006 study (NCT01335399) |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | E-Ld Cohort | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle |
| BG001 | Ld Cohort | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) 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 (NIH/OMB) | 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 | Change From Baseline to Progression of the Cell Surface Expression of CS1 From Bone Marrow-Derived Multiple Myeloma (MM) Cells | CS1 (CD2 subset-1, also known as CRACC, SLAMF7, CD319) expression levels in multiple myeloma cells were analyzed from bone-marrow aspirates collected at baseline and at time of progression through mean fluorescent intensity. The following conditions were considered to describe multiple myeloma cells expressing CS1 (CS1+/CD38++/CD138+/CD56+/CD19-/CD45DIM) | All treated participants with measurements available at baseline and at time of progression. No participants in any of the 2 cohorts had available measurements both at baseline and time of progression | Posted | From baseline (screening) to time of progression (up to approximately 54 months) |
|
| ||||||||||||||||||||||
| Secondary | Percent of Bone Marrow-Derived Multiple Myeloma (MM) Cells Expressing Cell Surface CS1 at Time of Progression | CS1 (CD2 subset-1, also known as CRACC, SLAMF7, CD319) expression levels in multiple myeloma cells were analyzed from bone-marrow aspirates collected at time of progression. The following conditions were considered to describe multiple myeloma cells expressing CS1 (CS1+/CD38++/CD138+/CD56+/CD19-/CD45DIM) | All treated participants with measurements available at time of progression. | Posted | Median | Full Range | Percent of cells expressing CS1 | Time of progression (up to approximately 54 months from pre-treatment screening) |
|
| |||||||||||||||||||
| Secondary | Levels of CS1 Soluble Form (sCS1) in Serum | Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection | All treated participants with measurements available either at baseline, at cycle 3 day 1 of study therapy or at time of progression. | Posted | Median | Full Range | ug/L | At baseline (screening), during main study therapy (cycle 3 day 1, up to 64 days) and at time of progression (up to approximately 31 months) |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in the Levels of CS1 Soluble Form (sCS1) in Serum During Therapy and At Progression | Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection | All treated participants with measurements available at baseline and at cycle 3 day 1 of study therapy or at baseline and at the time of progression. | Posted | Median | Full Range | ug/L | From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to time of progression (up to approximately 31 months) |
|
| |||||||||||||||||||
| Secondary | Change From Baseline in the Number of Circulating Multiple Myeloma (MM) Cells | Circulating MM cells isolated from peripheral blood | All treated participants with available circulating MM cells. Circulating MM cells were not collected for any of the participants. | Posted | From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to the time of progression (up to approximately 54 months) |
|
| ||||||||||||||||||||||
| Secondary | Change From Baseline in Cell Surface CS1 Expression Levels in Circulating Multiple Myeloma (MM) Cells | Circulating MM cells isolated from peripheral blood | All treated participants with available circulating MM cells and CS1 expression levels. Circulating MM cells were not collected for any of the participants. | Posted | From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to the time of progression (up to approximately 54 months) |
|
| ||||||||||||||||||||||
| Secondary | CS1 Expression Levels in Matched Samples of Bone Marrow-Derived Multiple Myeloma (MM) Cells and Circulating MM Cells | CS1 expression levels analyzed from matching bone marrow aspirates (for bone marrow-derived MM cells) and from peripheral blood (for circulating tumor cells) collected from the same participants | All treated participants with matched samples of bone marrow-derived MM cells and circulating MM cells. Circulating MM cells were not collected for any of the participants. | Posted | At baseline (screening), during main study therapy (cycle 3 day 1) and at time of progression (up to approximately 54 months) |
|
|
From first dose to 60 days following last dose (up to approximately 80 months)
Not provided
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-Ld Cohort | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | 8 | 13 | 9 | 13 | 13 | 13 |
| EG001 | Ld Cohort | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | 5 | 10 | 7 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | 23.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | 23.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Refractory anaemia with ringed sideroblasts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Delusional disorder, unspecified type | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Restrictive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 23.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 23.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 23.1 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | 23.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | 23.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | 23.1 | Systematic Assessment |
| |
| Macular degeneration | Eye disorders | 23.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 23.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 23.1 | Systematic Assessment |
| |
| Chest pain | General disorders | 23.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 23.1 | Systematic Assessment |
| |
| Fibrosis | General disorders | 23.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | 23.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 23.1 | Systematic Assessment |
| |
| Oedema | General disorders | 23.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 23.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | 23.1 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | 23.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Genitourinary tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 23.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | 23.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | 23.1 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | 23.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | 23.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Weight increased | Investigations | 23.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | 23.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Kyphosis | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | 23.1 | Systematic Assessment |
| |
| Carotid arteriosclerosis | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Spinal cord herniation | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | 23.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | 23.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Glomerulonephritis minimal lesion | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | 23.1 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Restrictive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 23.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | 23.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | 23.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 23.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | 23.1 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | 23.1 | 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 | Feb 19, 2013 | Jun 29, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| C546027 | elotuzumab |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 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 |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|