Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 20130394 | Other Identifier | Amgen Study ID |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multi-center, open-label, Phase 2 study of carfilzomib to monitor the safety and efficacy of long-term or continuing carfilzomib therapy for patients who previously completed a primary carfilzomib treatment study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carfilzomib | Experimental | Participants received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carfilzomib | Drug | Carfilzomib dose levels ranged from 11 to 27 mg/m² for 2- to 10-minute infusions and 36 to 56 mg/m² for 30-minute infusions. Carfilzomib doses were administered on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. Dose level reduction to a minimum dose of 11 mg/m² for toxicity was permitted. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Peripheral Neuropathy | Participants with peripheral neuropathy or peripheral neuropathy-related adverse events, including hypoaesthesia, paraesthesia, dysaesthesia, and neuropathic pain. | From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. |
| Number of Participants With Adverse Events | Adverse events (AEs) were assigned a severity grade using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading scale version 3.0. Per protocol, adverse events were collected if they led to dose modification or dose discontinuation, were grade ≥ 3 or serious, or were events of peripheral neuropathy (any grade). A serious AE is one that met one or more of the following criteria:
| From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Since participants were only followed up to 30 days after administration of last dose of study drug per protocol, Kaplan-Meier estimates of overall survival were not calculated. The number of participants who died within 30 days after administration of last dose of study drug is reported. | From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Oncology Hematology | Scottsdale | Arizona | 85258 | United States | ||
| Tower Cancer Research Foundation |
Not provided
This study was conducted at 23 centers in the United States and Canada from April 2009 to May 2017.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Solid Tumors | Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib. |
| 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 | Mar 25, 2011 | Apr 9, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Progression-free Survival | Progression-free survival (PFS) was defined as the time between the start of treatment and first evidence of documented disease progression or death (due to any cause), whichever occurred first. Disease progression was determined by the local investigator for regimens with the same baseline using the International Uniform Response Criteria (IMWG-URC) for participants with multiple myeloma and Response Evaluation Criteria in Solid Tumors (RECIST) criteria for solid tumor participants. PFS was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency. | From first dose of study drug in study PX-171-010 to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. |
| Time to Progression | Time to progression (TTP) was defined as the time between start of treatment to the first documentation of disease progression. TTP was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency. | From first dose of study drug in study PX-171-010 to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. |
| Beverly Hills |
| California |
| 90211 |
| United States |
| City of Hope National Medial Center | Duarte | California | 91010 | United States |
| University of California Medical Center | San Francisco | California | 94143 | United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| Winship Cancer Institute - Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Maryland, Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110-1093 | United States |
| John Theurer Cancer Center at Hackensack UMC | Hackensack | New Jersey | 07601 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203-1632 | United States |
| Texas Oncology Cancer Center | Austin | Texas | 78731 | United States |
| The University of Texas, MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Northwest Cancer Center | Houston | Texas | 77090 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| University of Toronto, Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3t 1E2 | Canada |
| FG001 | Multiple Myeloma | Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib. |
| Received Treatment |
|
| COMPLETED | Completed final visit |
|
| NOT COMPLETED |
|
|
All participants who received at least 1 dose of carfilzomib after enrollment in PX-171-010.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Solid Tumors | Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib. |
| BG001 | Multiple Myeloma | Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead. | 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 | Number of Participants With Peripheral Neuropathy | Participants with peripheral neuropathy or peripheral neuropathy-related adverse events, including hypoaesthesia, paraesthesia, dysaesthesia, and neuropathic pain. | All participants who received at least 1 dose of carfilzomib after enrollment in PX-171-010. | Posted | Number | participants | From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. |
|
|
| |||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events | Adverse events (AEs) were assigned a severity grade using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading scale version 3.0. Per protocol, adverse events were collected if they led to dose modification or dose discontinuation, were grade ≥ 3 or serious, or were events of peripheral neuropathy (any grade). A serious AE is one that met one or more of the following criteria:
| All participants who received at least 1 dose of carfilzomib after enrollment in PX-171-010. | Posted | Number | participants | From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. |
| |||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Since participants were only followed up to 30 days after administration of last dose of study drug per protocol, Kaplan-Meier estimates of overall survival were not calculated. The number of participants who died within 30 days after administration of last dose of study drug is reported. | All participants who received at least 1 dose of carfilzomib after enrollment in PX-171-010. | Posted | Number | participants | From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. |
| |||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression-free survival (PFS) was defined as the time between the start of treatment and first evidence of documented disease progression or death (due to any cause), whichever occurred first. Disease progression was determined by the local investigator for regimens with the same baseline using the International Uniform Response Criteria (IMWG-URC) for participants with multiple myeloma and Response Evaluation Criteria in Solid Tumors (RECIST) criteria for solid tumor participants. PFS was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency. | Enrolled participants excluding those with no postbaseline endpoint data subsequent to at least 1 dose of the study drug on the PX-171-010 protocol and participants who lacked baseline data for those analyses that required baseline data. Only participants with regimens that continued from the initial study without baseline being reset are included. | Posted | Median | 95% Confidence Interval | months | From first dose of study drug in study PX-171-010 to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Progression | Time to progression (TTP) was defined as the time between start of treatment to the first documentation of disease progression. TTP was re-calculated whenever the baseline was reset due to addition of new anti-cancer therapy or increase of carfilzomib dose/frequency. | Enrolled participants excluding those with no postbaseline endpoint data subsequent to at least 1 dose of the study drug on the PX-171-010 protocol and participants who lacked baseline data for those analyses that required baseline data Only participants with regimens that continued from the initial study without baseline being reset are included. | Posted | Median | 95% Confidence Interval | months | From first dose of study drug in study PX-171-010 to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma. |
|
From first dose of study drug to 30 days after the last dose; median duration of treatment was 14 weeks for participants with solid tumors and 44 weeks for participants with multiple myeloma.
The protocol indicated that AEs leading to dose modification, dose discontinuation, CTCAE grade 3+, serious AEs and all-grade peripheral neuropathy AEs were collected in the study.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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 | Solid Tumors | Participants with solid tumors received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib. | 1 | 9 | 5 | 9 | 6 | 9 |
| EG001 | Multiple Myeloma | Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib. | 7 | 91 | 57 | 91 | 69 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Haemolytic uraemic syndrome | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Catheter sepsis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Haemophilus sepsis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Herpes zoster ophthalmic | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Intraspinal abscess | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 8.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Systematic Assessment |
| |
| Renal cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Sensation of pressure | General disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 8.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Facial palsy | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 28, 2017 | Apr 9, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C524865 | carfilzomib |
Not provided
Not provided
Not provided
| ≥ 65 years |
|
| Male |
|
| Black |
|
| Hispanic |
|
| Asian/Pacific Islander |
|
| 1 (Restricted but ambulatory) |
|
| 2 (Ambulatory but unable to work) |
|
| OG001 | Multiple Myeloma | Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib. |
|
|
|
|
| OG001 | Multiple Myeloma | Participants with multiple myeloma received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib. |
|
|
|
|