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MTD determined sub-optimal as efficacious treatment for renal cell carcinoma.
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The purpose of this study was to determine the maximum tolerated dose, safety, and effectiveness of lenalidomide (CC-5013) administered in combination with sunitinib as treatment for patients with renal cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Participants received an oral dose of lenalidomide MTD (mg) capsule administered in combination with a single dose of sunitinib 37.5 mg on days 1-21 of each 21-day cycle |
|
| Cohorts F and G | Experimental | Participants received an oral daily dose of lenalidomide on Days 1 to 21 in combination with a single oral daily dose of sunitinib 37.5 mg on days 1 to 14 or days 1 to 21 of each 21-day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide MTD mg by mouth (PO) daily for Days 1- 21 in combination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Maximum Tolerated Dose (MTD) | The MTD of lenalidomide in combination with sunitinib was defined as the highest dose level at which no more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). Dose limiting toxicities were: • Inability to deliver Lenalidomide in Cycle 1 due to a drug-related toxicity resulting in:
If ≤ 7 doses of lenalidomide or Sunitinib were missed in Cycle 1 due to non-drug related event, the participant data was to be included in the evaluation of dose escalation. | Within 21 days of first dose of treatment |
| Phase 2: Tumor Response Rate According to Response Evaluation Criteria In Solid Tumors (RECIST 1.1) | Tumor response was to be evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was to be defined by RECIST 1.1 criteria:
| After at least 3 cycles of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib | Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participants health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debora Barton, MD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States | ||
| Cleveland Clinic Main Campus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24914044 | Result | Rini B, Redman B, Garcia JA, Burris HA 3rd, Li S, Fandi A, Beck R, Jungnelius U, Infante JR. A phase I/II study of lenalidomide in combination with sunitinib in patients with advanced or metastatic renal cell carcinoma. Ann Oncol. 2014 Sep;25(9):1794-1799. doi: 10.1093/annonc/mdu212. Epub 2014 Jun 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg | Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle |
| FG001 | Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg | Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle |
| FG002 | Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg | Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population includes all participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg | Lenalidomide 10 mg and sunitinib 37.5 mg PO QD on Days 1 to 21 of each 21-day cycle |
| BG001 | Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Phase 1: Maximum Tolerated Dose (MTD) | The MTD of lenalidomide in combination with sunitinib was defined as the highest dose level at which no more than 1 out of 6 participants experienced a dose limiting toxicity (DLT). Dose limiting toxicities were: • Inability to deliver Lenalidomide in Cycle 1 due to a drug-related toxicity resulting in:
If ≤ 7 doses of lenalidomide or Sunitinib were missed in Cycle 1 due to non-drug related event, the participant data was to be included in the evaluation of dose escalation. | Safety population includes all participants who received at least one dose of the study drug. | Posted | Number | mg | Within 21 days of first dose of treatment |
|
Phase 1 Only. From the date of the first study drug dose to within 28 days after the study drug treatment was discontinued.
Median treatment duration with Lenalidomide and Sunitinib was shortest in Cohort A at 41 days (range = 17 to 189 days) and longest in Cohort G = 97 days (range: 60 to 125 days) of lenalidomide treatment and 97.5 days (range = 54 to 125 days) of Sunitinib
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 | Cohort A | Lenalidomide 10 mg QD and sunitinib 37.5 mg QD on Days 1-21 of each 21-day cycle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne McClain,Senior Manager | Celgene Corporation | 1-888-260-1599 | clinicaltrialsdisclosure@celgene.com |
Not provided
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
Not provided
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| Sunitinib | Drug | Sunitinib 37.5 mg PO daily on days 1-21 of each 21-day cycle in Cohort A or on days 1-14 in Cohorts F and G |
|
|
| First day of study drug to within 28 days after the last dose of the last study drug; The duration of exposure to lenalidomide and sunitinib was 7.0 to 327 and 7.0 to 328 days respectively |
| Phase 1 : Tumor Response Rate According to RECIST 1.1 | Tumor response was evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was evaluated using the Response Criteria Evaluation in Solid Tumors (RECIST 1.1) criteria: Treatment response includes both complete response and partial response
| Every 3 cycles; up to month 25 |
| Progression Free Survival (PFS) | Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first. | Day 1 of study drug to disease progression or death |
| Duration of Response | Duration of response was defined as the time from the initial response date to progressive disease (PD) for participants who achieved an objective confirmed complete response (CR) or partial response (PR) | Day 1 of initial response date to progressive disease |
| Overall Survival (OS) | Overall survival was defined as the time from the start of study drug therapy to death. | Day 1 of study drug to death |
| Cleveland |
| Ohio |
| 44195 |
| United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Withdrawal by Subject |
|
| Death |
|
| Physician decision and disease related |
|
Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
| BG002 | Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg | Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity)
| Number | participants |
|
| OG000 | Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg | Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle |
|
|
| Primary | Phase 2: Tumor Response Rate According to Response Evaluation Criteria In Solid Tumors (RECIST 1.1) | Tumor response was to be evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was to be defined by RECIST 1.1 criteria:
| Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study. | Posted | After at least 3 cycles of treatment |
|
|
| Secondary | Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Lenalidomide and Sunitinib | Adverse event (AE) = any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a participant during the course of a study, including new intercurrent illness, worsening concomitant illness, injury, or any concomitant impairment of participants health, including laboratory test values, regardless of etiology. Serious adverse event (SAE) = any AE which: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAE = any AE occurring or worsening on or after the first treatment with any study drug. Related = suspected by investigator to be related to study treatment. National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events [CTCAE], Version 4.0, grades: 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, 5 = death | Safety population includes all participants who received at least one dose of study drug. | Posted | Number | participants | First day of study drug to within 28 days after the last dose of the last study drug; The duration of exposure to lenalidomide and sunitinib was 7.0 to 327 and 7.0 to 328 days respectively |
|
|
|
| Secondary | Phase 1 : Tumor Response Rate According to RECIST 1.1 | Tumor response was evaluated every 3 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response was evaluated using the Response Criteria Evaluation in Solid Tumors (RECIST 1.1) criteria: Treatment response includes both complete response and partial response
| Intent to Treat Population includes participants who took at least one dose of study drug. Study participants with stable disease also reported. | Posted | Number | participants | Every 3 cycles; up to month 25 |
|
|
|
| Secondary | Progression Free Survival (PFS) | Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first. | Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including MTD, were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study. | Posted | Day 1 of study drug to disease progression or death |
|
|
| Secondary | Duration of Response | Duration of response was defined as the time from the initial response date to progressive disease (PD) for participants who achieved an objective confirmed complete response (CR) or partial response (PR) | Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study. | Posted | Day 1 of initial response date to progressive disease |
|
|
| Secondary | Overall Survival (OS) | Overall survival was defined as the time from the start of study drug therapy to death. | Analysis was not performed due to the early termination of the study. The cumulative frequency and severity of toxicities observed at each dose level, including Maximum Tolerated Dose (MTD), were higher than expected and evident during all cycles and all dose levels in Phase 1. The decision was made not to open the Phase 2 portion of the study. | Posted | Day 1 of study drug to death |
|
|
| 3 |
| 5 |
| 5 |
| 5 |
| EG001 | Cohort F | Lenalidomide 10 mg QD on Days 1-21 of each 21-day cycle and sunitinib 37.5 mg QD on Days 1-14 of each 21-day cycle | 4 | 7 | 7 | 7 |
| EG002 | Cohort G | Lenalidomide 15 mg QD on Days 1-21 of each 21-day cycle and sunitinib 37.5 mg QD on Days 1-14 of each 21-day cycle | 2 | 4 | 4 | 4 |
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| General Physical Health Deterioration | General disorders | MedDRA | Systematic Assessment |
|
| Influenza Like Illness | General disorders | MedDRA | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Thrombocytpenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haemogloinaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Splinter Haemorrhages | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 14.0 | Systematic Assessment |
|
| Thyroiditis Subacute | Endocrine disorders | MedDRA 14.0 | Systematic Assessment |
|
| Lacrimation Increased | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye Swelling | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Periorbital oedema | Eye disorders | MedDRA 14.0 | Systematic Assessment |
|
| Tear discolouration | Eye disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dental Caries | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dry Mouth | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Tongue Disorder | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Tongue Ulceration | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Mucosal Inflammation | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Non-cardiac Chest Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Early Satiety | General disorders | MedDRA | Systematic Assessment |
|
| Face Oedema | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Influenza Like Illness | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Seasonal Allergy | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Infected Bites | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Post Procedural Complication | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Blood Creatinine Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Transaminases Increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| White Blood Cell Count Decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood Alkaline Phosphatase | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | MedDRA | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Decreasd Appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Haemoglobinuria | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Scrotal Oedema | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Orophryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Hair Colour Changes | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash Maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Scar Pain | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Upper Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Sputum Discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
Multicenter publications must include input from investigators and Celgene, and agreement be established before publication. Results from a center cannot be submitted for publication prior to a multicenter publication unless it is more than 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene ≤ 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to ≤ 90 days.
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| 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 |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D007211 | Indoles |
|
| ≥ 1 TEAE leading to stopping lenalidomide |
|
| ≥ 1 TEAE leading to stopping sunitinib |
|
| ≥ 1 TEAE -> dose reduction/interrruption of Len |
|
| ≥ 1 TEAE dose reduction/interrruption of Sunitinib |
|
| Participants with ≥1 TEAE related to lenalidomide |
|
| Participants with ≥1 TEAE related to Sunitinib |
|
| ≥ 1 NCI CTC Gr 3 or higher TEAE |
|
| ≥ 1 NCI CTC Gr 3 or higher related to lenalidomide |
|
| ≥ 1 NCI CTC Gr 3 or higher related to Sunitinib |
|
| ≥ 1 serious TEAE related to lenalidomide |
|
| ≥ 1 serious TEAE related to sunitinib |
|
| Title | Measurements |
|---|---|
|
| Stable Disease |
|