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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
Not provided
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The purpose of this study is to determine the efficacy of Lenalidomide/Dexamethasone + Elotuzumab in the subjects with newly diagnosed, previously untreated Multiple Myeloma (MM) in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) | Experimental | Drug: Lenalidomide Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug Drug: Dexamethasone Tablets, Oral 28 mg and Intravenous (IV) 8 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug Biological: Elotuzumab (BMS-901608) Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug |
|
| Arm B: Lenalidomide + Dexamethasone | Active Comparator | Drug: Lenalidomide Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug Drug: Dexamethasone Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat 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 |
|---|---|---|
| Objective Response Rate (ORR) of Participants Treated With Elotuzumab + Lenalidomide/Dexamethasone (E-Ld) | ORR is the proportion of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or PR as determined by investigator using the International Myeloma Working Group (IMWG) response criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required. | From first dose until documented response (assessed up to February 2017, approximately 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is the percentage of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) as determined by investigator using the International Myeloma Working Group (IMWG) response criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required. |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Nagoya | Aichi-ken | 4600001 | Japan | ||
| Local Institution |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32398792 | Derived | Suzuki A, Kakugawa S, Miyoshi M, Hori M, Suzuki K, Furukawa Y, Ohta K. Soluble SLAMF7 is a predictive biomarker for elotuzumab therapy. Leukemia. 2020 Nov;34(11):3088-3090. doi: 10.1038/s41375-020-0860-7. Epub 2020 May 12. No abstract available. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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82 participants were randomized and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) | Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered:
On weeks when elotuzumab is NOT administered: - 40 mg taken orally Elotuzumab (BMS-901608)
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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 16, 2017 | Sep 9, 2019 |
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| Dexamethasone |
| Drug |
|
| Elotuzumab (BMS-901608) | Biological |
|
| From first dose until documented response, up to approximately 72 months |
| Progression Free Survival (PFS) | PFS is defined as the time from randomization to the date of the first documented tumor progression, as determined by the investigator using the International Myeloma Working Group (IMWG) response criteria, or to death due to any cause, provided death does not occur more than 10 weeks (2 or more assessment visits) after the last tumor assessment. Clinical deterioration will not be considered progression. | From randomization to the date of first documented tumor progression or death due to any cause, up to approximately 72 months |
| Progression Free Survival (PFS) Rate | PFS rate is defined as the percentage of participants who have neither progressed nor died at the specified timepoints | From randomization up to the specified timepoints, up to 3 years |
| Nagoya |
| Aichi-ken |
| 4678602 |
| Japan |
| Local Institution | Aomori | Aomori | 0308553 | Japan |
| Local Institution | Chiba | Chiba | 2608677 | Japan |
| Local Institution | Kamogawa-shi | Chiba | 2968602 | Japan |
| Local Institution | Matsuyama | Ehime | 7900024 | Japan |
| Local Institution | Fukuoka | Fukuoka | 8128582 | Japan |
| Local Institution | Maebashi | Gunma | 3718511 | Japan |
| Local Institution | Shibukawa-shi | Gunma | 3770280 | Japan |
| Local Institution | Fukuyama-shi | Hiroshima | 7200001 | Japan |
| Local Institution | Morioka | Iwate | 0208505 | Japan |
| Local Institution | Kagoshima | Kagoshima-ken | 8920853 | Japan |
| Local Institution | Kyoto | Kyoto | 6028566 | Japan |
| Local Institution | Sendai | Miyagi | 9808574 | Japan |
| Local Institution | Niigata | Niigata | 9518566 | Japan |
| Local Institution | Okayama | Okayama-ken | 7011192 | Japan |
| Local Institution | Osaka | Osaka | 5300012 | Japan |
| Local Institution | Osaka | Osaka | 5438555 | Japan |
| Local Institution | Kawagoe-shi | Saitama | 3508550 | Japan |
| Local Institution | Hamamatsu | Shizuoka | 4313192 | Japan |
| Local Institution | Utsunomiya | Tochigi | 3200834 | Japan |
| Local Institution | Bunkyo-ku | Tokyo | 1138677 | Japan |
| Local Institution | Koto-ku | Tokyo | 1358550 | Japan |
| Local Institution | Shibuya-ku | Tokyo | 1508935 | Japan |
| Local Institution | Shinjuku-Ku | Tokyo | 1608582 | Japan |
| Local Institution | Shinjuku-ku | Tokyo | 1628655 | Japan |
| Local Institution | Tachikawa-shi | Tokyo | 1900014 | Japan |
| Local Institution | Kasama-shi | 3091793 | Japan |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
| FG001 | Arm B: Lenalidomide + Dexamethasone | Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All treated particpants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) | Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered:
On weeks when elotuzumab is NOT administered: - 40 mg taken orally Elotuzumab (BMS-901608)
|
| BG001 | Arm B: Lenalidomide + Dexamethasone | Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each 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 | All treated participants | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | All treated participants | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | 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 | Objective Response Rate (ORR) of Participants Treated With Elotuzumab + Lenalidomide/Dexamethasone (E-Ld) | ORR is the proportion of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or PR as determined by investigator using the International Myeloma Working Group (IMWG) response criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required. | Participants treated with E-Ld | Posted | Number | 70% Confidence Interval | Percentage of participants | From first dose until documented response (assessed up to February 2017, approximately 24 months) |
|
|
| |||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR is the percentage of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) as determined by investigator using the International Myeloma Working Group (IMWG) response criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required. | All randomized participants | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose until documented response, up to approximately 72 months |
| |||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS is defined as the time from randomization to the date of the first documented tumor progression, as determined by the investigator using the International Myeloma Working Group (IMWG) response criteria, or to death due to any cause, provided death does not occur more than 10 weeks (2 or more assessment visits) after the last tumor assessment. Clinical deterioration will not be considered progression. | All randomized participants | Posted | Median | 95% Confidence Interval | Months | From randomization to the date of first documented tumor progression or death due to any cause, up to approximately 72 months |
| |||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) Rate | PFS rate is defined as the percentage of participants who have neither progressed nor died at the specified timepoints | All randomized participants | Posted | Number | 95% Confidence Interval | Percentage of Participants | From randomization up to the specified timepoints, up to 3 years |
|
|
All-cause mortality was assessed from date of first dose to study completion (up to approximately 77 months). Serious Adverse events and other adverse events were assessed from date of first dose to 60 days following date of last dose (up to approximately 74 months).
All randomized 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 | Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608) | Lenalidomide 25 mg taken orally once daily, Days 1 - 21 of each cycle Dexamethasone Administered on Days 1, 8, 15, and 22 of each cycle: On weeks when elotuzumab is administered:
On weeks when elotuzumab is NOT administered: - 40 mg taken orally Elotuzumab (BMS-901608)
| 2 | 40 | 26 | 40 | 39 | 40 |
| EG001 | Arm B: Lenalidomide + Dexamethasone | Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle | 6 | 42 | 27 | 42 | 42 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Eosinophilic myocarditis | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | 24.0 | Systematic Assessment |
| |
| Cataract subcapsular | Eye disorders | 24.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Ischaemic enteritis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Chills | General disorders | 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 24.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.0 | Systematic Assessment |
| |
| Sudden death | General disorders | 24.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Disseminated varicella zoster virus infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Peri-implantitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pneumonia cryptococcal | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Near drowning | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 24.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | 24.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Drug reaction with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | 24.0 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 24.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | 24.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | 24.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | 24.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | 24.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | 24.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 24.0 | Systematic Assessment |
| |
| Malaise | General disorders | 24.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 24.0 | Systematic Assessment |
| |
| Oedema | General disorders | 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 24.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | 24.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Hepatitis B reactivation | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 24.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | 24.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 24.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | 24.0 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 24.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 24.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | 24.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | 24.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 24.0 | 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_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 2, 2017 | Sep 9, 2019 | SAP_002.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 |
|---|---|
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| 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 |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Arm B: Lenalidomide + Dexamethasone | Lenalidomide 25 mg taken orally once a day, Days 1 - 21 of each cycle Dexamethasone 40 mg taken orally, Days 1, 8, 15, and 22 of each cycle |
|
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| Participants |
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