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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This is a phase 2, single arm, open-label, multicenter study to evaluate the feasibility and tolerance of the combination of elotuzumab, lenalidomide, and dexamethasone in the induction, consolidation, and maintenance treatment of transplant eligible, newly diagnosed multiple myeloma patients.
The primary purpose of this study is to evaluate the feasibility of using the combination of elotuzumab, lenalidomide, and dexamethasone (ERd) as induction therapy and the ability of the combination to facilitate the start of autologous stem cell transplantation (ASCT) in transplant-eligible patients newly diagnosed with multiple myeloma. In addition to induction, the efficacy, safety, and tolerability of ERd as consolidation and maintenance therapy in these patients will be observed.
Eligible patients will undergo four 28-day cycles of an induction regimen of elotuzumab, lenalidomide, and dexamethasone. Following completion of 4 cycles of induction therapy, all patients will undergo standard mobilization, collection of stem cells, and then ASCT using a melphalan conditioning regimen as per institutional guidelines.
Toxicity evaluation will be interrupted during the stem cell procedure and will resume with the onset of consolidation. Adverse events will be collected, however, from the end of induction up to mobilization.
Consolidation therapy will begin 70 to 120 days following ASCT and will consist of four 28-day cycles of elotuzumab, lenalidomide, and dexamethasone. All patients that do not experience progressive disease will begin maintenance therapy of elotuzumab, lenalidomide, and dexamethasone. The duration of maintenance will be 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERd Therapy | Experimental | INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| elotuzumab | Drug | Given intravenously (IV) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Induction Feasibility Rate (IFR) | Defined as the percentage of patients who successfully complete four 28-day cycles of induction therapy with elotuzumab, lenalidomide and dexamethasone (ERd) and start autologous stem cell transplantation (ASCT). | approximately 22 weeks (16 weeks of treatment and 6 weeks allowance for planning and scheduling mobilization and ASCT). |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate (CRR) for Complete Time on Study | Defined as the percentage of patients who achieve a complete response (CR) or near complete response (nCR) to treatment at each stage of the study (induction, ASCT, consolidation, end of study) per International Myeloma Working Group (IMWG) and European Group for Blood and Marrow Transplantation (EBMT) criteria.CR=bone marrow contains ≤5% plasma cells; negative immunofixation on serum and urine; disappearance of soft tissue plasmacytomas. nCR = the absence of myeloma protein on electrophoresis, with positive immunofixation, stable bone disease, and a normal serum calcium concentration. Patient must have completed at least 1 cycle to be included in analysis. |
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Inclusion Criteria:
Newly diagnosed myeloma requiring systemic chemotherapy as per International Myeloma Working Group (IMWG) uniform criteria and Diagnostic Criteria and Staging for Multiple Myeloma
Eligible and plan to undergo ASCT in first remission
Measurable disease, prior to initial treatment as indicated by one or more of the following:
Ability to take aspirin or other venous thromboembolism (VTE) anticoagulant therapy
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 thru 2
Adequate hematologic, renal, and liver function.
All study participants must be registered into the mandatory Revlimid REMS® program and must be willing and able to comply with the requirements of that program.
Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 28 days following last dose of study drugs. Male patients must also refrain from donating semen or sperm during their participation in the study.
Willingness and ability to comply with study and follow-up procedures.
Ability to understand the nature of this study and give written informed consent.
Exclusion Criteria:
Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome
Plasma cell leukemia
Waldenström's macroglobulinemia or IgM myeloma
Presence of other active cancers, or history of treatment for invasive cancer ≤5 years. Patients with Stage I cancer who have received definitive local treatment and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e., non-invasive) are eligible, as are patients with a history of non-melanoma skin cancer.
Radiotherapy to multiple sites or immunotherapy within 4 weeks before start of protocol treatment (localized radiotherapy to a single site at least 1 week before start is permissible)
Major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.
Acute active infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to first dose of study treatment
Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea Grade ≥2, and malabsorption syndrome)
Any of the following cardiac diseases currently or within the last 6 months:
Known seropositive for or active viral infection with human immunodeficiency virus or hepatitis A, B, or C virus. Patients who are seropositive because of hepatitis B virus vaccine are eligible.
Any clinically significant medical disease or condition that, in the treating Investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent
Pregnant or lactating females
Contraindication to any of the required concomitant drugs, including dexamethasone, H1 and H2 blockers, and acetaminophen, or if patient has a history of prior thrombotic disease, warfarin or low molecular weight heparin
No health coverage, or if the copay for lenalidomide is not acceptable to the patient.
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Jesus Berdeja, MD | SCRI Development Innovations, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States | ||
| Center for Cancer and Blood Disorders |
One participant withdrew consent before the study treatment assignment.
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| ID | Title | Description |
|---|---|---|
| FG000 | ERd Therapy | INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1. elotuzumab: Given intravenously (IV) Lenalidomide: Given by IV Dexamethasone: Given orally (PO) or by IV autologous stem cell transplantation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2016 |
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| Lenalidomide | Drug | Given by IV |
|
|
| Dexamethasone | Drug | Given orally (PO) or by IV |
|
|
| autologous stem cell transplantation | Procedure |
|
|
| every 4 weeks until end of treatment visit, and every 3 months thereafter up to 3 years |
| Overall Response Rate (ORR) for Complete Time on Study | Defined as percentage of patients receiving at least 1 cycle with confirmed complete response, very good partial response, or partial response (CR, VGPR, or PR) to treatment at each stage of the study (induction, ASCT, consolidation, end of study) per IMWG and EBMT criteria. CR=bone marrow contains ≤5% plasma cells; negative fixation on serum and urine; the disappearance of soft tissue plasmacytomas. VGPR=serum and urine M-protein detectable by immunofixation but not by electrophoresis or ≥90% reduction from baseline serum and urine M-protein level <100mg for 24h and In case of presence of soft tissue plasmacytoma(s) at baseline, the disappearance of any soft tissue plasmacytomas. PR=≥50% reduction from baseline in serum M-protein and ≥90% reduction from baseline in 24h urinary M-protein or urine M-protein <200 mg/24 hours and In case of presence of soft tissue plasmacytoma(s) at baseline, a reduction in the sum of products of the two longest perpendicular diameters (SPD) by >50%. | every 4 weeks until end of treatment visit, and every 3 months thereafter up to 3 years |
| Progression-free Survival (PFS) | The time from start of induction treatment to documented progressive disease (PD) or death from any cause up to 3 years post first study treatment. PD is defined as an increase of ≥ 25% from the nadir in at least one of the following criteria: serum M-protein (absolute increase must be ≥0.5 g/dL); urine M-protein (absolute increase must be ≥200 mg/24h) ; only in patients with non-measurable serum and urine M-protein levels: difference in involved and uninvolved FLC levels (absolute increase must be >10 mg/dL); only in patients with non-measurable serum and urine M-protein levels and non-measurable disease by FLC levels, bone marrow plasma cell % (absolute % must be ≥10%) OR Definite development of new bone lesions or soft tissue plasmacytomas OR definite increase in the size of existing bone lesions or soft tissue plasmacytomas OR Development of hypercalcemia (corrected serum Ca >11.5mg/dL) for patients without hypercalcemia at baseline. Must have completed 1 cycle to be included. | every 4 weeks until end of treatment visit, and every 3 months thereafter up to 3 years |
| Overall Survival (OS) | Defined as the time from start of induction treatment to 3 years post first study treatment or death from any cause, whichever comes first. Patient must have completed at least 1 cycle to be included in analysis. | every 4 weeks until end of treatment visit, and up to 3 years thereafter |
| Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety | Safety data and abnormal lab values and abnormal vital signs were collected and assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V4.03). | weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation, and monthly for 24 months of Maintenance, up to 30 days after last dose of study drugs. |
| Consolidation Feasibility Rate (CFR) | defined as the percentage of patients starting induction treatment with ERd successfully completing treatment to end of consolidation | approximately 55 weeks (16 weeks of induction treatment, 6 weeks allowance for planning and scheduling mobilization and ASCT, 17 weeks pause in treatment after ASCT, 16 weeks of consolidation treatment). |
| Maintenance Feasibility Rate (MFR) | defined as the percentage of patients starting induction treatment with ERd successfully completing treatment to end of maintenance | approximately 159 weeks (16 weeks of induction treatment, 6 weeks allowance for planning and scheduling mobilization and ASCT, 17 weeks pause in treatment after ASCT, 16 weeks of consolidation treatment, 104 weeks/2 years of maintenance treatment) |
| Bethesda |
| Maryland |
| 20817 |
| United States |
| HCA Midwest Health/Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Tennessee Oncology | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ERd Therapy | INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1. elotuzumab: Given intravenously (IV) Lenalidomide: Given by IV Dexamethasone: Given orally (PO) or by IV autologous stem cell transplantation |
| 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 |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Induction Feasibility Rate (IFR) | Defined as the percentage of patients who successfully complete four 28-day cycles of induction therapy with elotuzumab, lenalidomide and dexamethasone (ERd) and start autologous stem cell transplantation (ASCT). | Four participants who completed four 28-day cycles of induction therapy refused transplantation (ASCT). These 4 participants were excluded from the IFR analysis. | Posted | Count of Participants | Participants | approximately 22 weeks (16 weeks of treatment and 6 weeks allowance for planning and scheduling mobilization and ASCT). |
|
|
| ||||||||||||||||||||||||||
| Secondary | Complete Response Rate (CRR) for Complete Time on Study | Defined as the percentage of patients who achieve a complete response (CR) or near complete response (nCR) to treatment at each stage of the study (induction, ASCT, consolidation, end of study) per International Myeloma Working Group (IMWG) and European Group for Blood and Marrow Transplantation (EBMT) criteria.CR=bone marrow contains ≤5% plasma cells; negative immunofixation on serum and urine; disappearance of soft tissue plasmacytomas. nCR = the absence of myeloma protein on electrophoresis, with positive immunofixation, stable bone disease, and a normal serum calcium concentration. Patient must have completed at least 1 cycle to be included in analysis. | Participants who completed at least one cycle of treatment were included in the analysis. One participant didn't complete cycle 1 due to adverse events; therefore, excluded from the analysis. | Posted | Count of Participants | Participants | every 4 weeks until end of treatment visit, and every 3 months thereafter up to 3 years |
| ||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) for Complete Time on Study | Defined as percentage of patients receiving at least 1 cycle with confirmed complete response, very good partial response, or partial response (CR, VGPR, or PR) to treatment at each stage of the study (induction, ASCT, consolidation, end of study) per IMWG and EBMT criteria. CR=bone marrow contains ≤5% plasma cells; negative fixation on serum and urine; the disappearance of soft tissue plasmacytomas. VGPR=serum and urine M-protein detectable by immunofixation but not by electrophoresis or ≥90% reduction from baseline serum and urine M-protein level <100mg for 24h and In case of presence of soft tissue plasmacytoma(s) at baseline, the disappearance of any soft tissue plasmacytomas. PR=≥50% reduction from baseline in serum M-protein and ≥90% reduction from baseline in 24h urinary M-protein or urine M-protein <200 mg/24 hours and In case of presence of soft tissue plasmacytoma(s) at baseline, a reduction in the sum of products of the two longest perpendicular diameters (SPD) by >50%. | Participants who completed at least one cycle of treatment were included in the analysis. One participant didn't complete cycle 1 due to adverse events; therefore, excluded from the analysis. | Posted | Count of Participants | Participants | every 4 weeks until end of treatment visit, and every 3 months thereafter up to 3 years |
| ||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | The time from start of induction treatment to documented progressive disease (PD) or death from any cause up to 3 years post first study treatment. PD is defined as an increase of ≥ 25% from the nadir in at least one of the following criteria: serum M-protein (absolute increase must be ≥0.5 g/dL); urine M-protein (absolute increase must be ≥200 mg/24h) ; only in patients with non-measurable serum and urine M-protein levels: difference in involved and uninvolved FLC levels (absolute increase must be >10 mg/dL); only in patients with non-measurable serum and urine M-protein levels and non-measurable disease by FLC levels, bone marrow plasma cell % (absolute % must be ≥10%) OR Definite development of new bone lesions or soft tissue plasmacytomas OR definite increase in the size of existing bone lesions or soft tissue plasmacytomas OR Development of hypercalcemia (corrected serum Ca >11.5mg/dL) for patients without hypercalcemia at baseline. Must have completed 1 cycle to be included. | Participants who completed at least one cycle of treatment were included in the analysis. One participant didn't complete cycle 1 due to adverse events; therefore, excluded from the analysis. | Posted | Median | 99% Confidence Interval | months | every 4 weeks until end of treatment visit, and every 3 months thereafter up to 3 years |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Defined as the time from start of induction treatment to 3 years post first study treatment or death from any cause, whichever comes first. Patient must have completed at least 1 cycle to be included in analysis. | Participants who completed at least one cycle of treatment were included in the analysis. One participant didn't complete cycle 1 due to adverse events; therefore, excluded from the analysis. | Posted | Median | 90% Confidence Interval | months | every 4 weeks until end of treatment visit, and up to 3 years thereafter |
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety | Safety data and abnormal lab values and abnormal vital signs were collected and assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V4.03). | All treated patients | Posted | Count of Participants | Participants | weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation, and monthly for 24 months of Maintenance, up to 30 days after last dose of study drugs. |
| ||||||||||||||||||||||||||||
| Secondary | Consolidation Feasibility Rate (CFR) | defined as the percentage of patients starting induction treatment with ERd successfully completing treatment to end of consolidation | All patients starting induction treatment | Posted | Count of Participants | Participants | approximately 55 weeks (16 weeks of induction treatment, 6 weeks allowance for planning and scheduling mobilization and ASCT, 17 weeks pause in treatment after ASCT, 16 weeks of consolidation treatment). |
| ||||||||||||||||||||||||||||
| Secondary | Maintenance Feasibility Rate (MFR) | defined as the percentage of patients starting induction treatment with ERd successfully completing treatment to end of maintenance | All patients starting induction treatment | Posted | Count of Participants | Participants | approximately 159 weeks (16 weeks of induction treatment, 6 weeks allowance for planning and scheduling mobilization and ASCT, 17 weeks pause in treatment after ASCT, 16 weeks of consolidation treatment, 104 weeks/2 years of maintenance treatment) |
|
weekly for 8 weeks, then every 2 weeks till the start of mobilization for Induction treatment and 70-120 days post-ASCT, every 2 weeks during 16 weeks of Consolidation treatment, and monthly for 24 months of Maintenance treatment up to 30 days after last dose of study drugs.
Assessments will be made through analysis of the reported incidence of treatment-emergent Serious Adverse Events (SAEs) and non-serious adverse events (AEs).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ERd Therapy | INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1. elotuzumab: Given intravenously (IV) Lenalidomide: Given by IV Dexamethasone: Given orally (PO) or by IV autologous stem cell transplantation | 9 | 52 | 20 | 52 | 52 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cardiac perforation | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Enterocolitis bacterial | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia parainfluenzae viral | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Ataxia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
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| Deafness | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
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| Ectropion | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| Eye irritation | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 25.0 | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Glossodynia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Poor dental condition | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Feeling jittery | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Infusion site bruising | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Temperature intolerance | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Unevaluable event | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Post procedural erythema | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood immunoglobulin G decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood phosphorus decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Immunoglobulins decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysgraphia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypogeusia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Mental impairment | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Affect lability | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Disorientation | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hallucination, visual | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Urine flow decreased | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspareunia | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Perineal pain | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Prostatic obstruction | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vulvovaginal inflammation | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lower respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Leukoplakia | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA 25.0 | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA 25.0 | Systematic Assessment |
| |
| Aortic dilatation | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Cannon Development Innovations, LLC | Sarah Cannon Development Innovations, LLC | 844-710-6157 | CANN.InnovationsMedical@sarahcannon.com |
| Aug 19, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D019337 | Hematologic Neoplasms |
| 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 |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C546027 | elotuzumab |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| 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
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|