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The purpose of this study is to identify a well-tolerated, effective dose and schedule of AMG 531 for the treatment of Chemotherapy Induced Thrombocytopenia (CIT) in subjects with lymphoma receiving multi-cycle chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm: AMG 531 Dose-Escalating Cohort Study | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 531 | Biological | Planned Cohorts:
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Platelet Nadir | Change in platelet nadir from the previous qualifying cycle to the first treatment cycle. | 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia | Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L, and <25 x 10^9/L) | 32 weeks |
| Duration of Grade 3 or 4 Thrombocytopenia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
| FDA-approved Drug Labeling | View source |
Not provided
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Participants were enrolled from 15 March 2006 through 28 April 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Romiplostim 100 µg | Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy |
| FG001 | Romiplostim 300 µg | Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Duration of grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L and <25 x 10^9/L, respectively)
| 32 weeks |
| Percentage of Subjects That Received Platelet Transfusions | Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle | 32 weeks |
| FG002 | Romiplostim 700 µg | Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy |
| FG003 | Romiplostim 1000 µg | Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Romiplostim 100 µg | Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy |
| BG001 | Romiplostim 300 µg | Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy |
| BG002 | Romiplostim 700 µg | Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy |
| BG003 | Romiplostim 1000 µg | Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy |
| BG004 | 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 | Year |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participant |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Platelet Nadir | Change in platelet nadir from the previous qualifying cycle to the first treatment cycle. | Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol. | Posted | Mean | Standard Error | 10^9/L | 32 weeks |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Experiencing Grade 3 or 4 Thrombocytopenia | Percentage of subjects experiencing grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L, and <25 x 10^9/L) | Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol. | Posted | Number | Percentage of participants | 32 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Grade 3 or 4 Thrombocytopenia | Duration of grade 3 and/or 4 thrombocytopenia (<50 x 10^9/L and <25 x 10^9/L, respectively) | Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol. | Posted | Mean | Standard Error | Day | 32 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects That Received Platelet Transfusions | Percentage of subjects that received platelet transfusions during the first romiplostim treatment cycle | Efficacy Analysis Set, composed of all enrolled participants who received at least one dose of romiplostim, completed the first treatment cycle, and were not replaced per the protocol. | Posted | Number | Percentage of participants | 32 weeks |
|
From the first administration of investigation product through 30 days after the last dose of investigational product or end of the study (including the follow-up period), whichever is longer.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
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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 | Romiplostim 100 µg | 0 | 8 | 6 | 8 | |||
| EG001 | Romiplostim 300 µg | 1 | 11 | 9 | 11 | |||
| EG002 | Romiplostim 700 µg | 3 | 11 | 7 | 11 | |||
| EG003 | Romiplostim 1000 µg | 3 | 9 | 9 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Staphylococcal infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diastolic dysfunction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 11.0 | Systematic Assessment |
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| Visual disturbance | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Hyperchlorhydria | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Rectal fissure | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Catheter site related reaction | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Back injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Chromaturia | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
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| Urine flow decreased | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
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| Penile oedema | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Increased tendency to bruise | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Haematopoietic stem cell mobilisation | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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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 multi-center 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 |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D009369 | Neoplasms |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| C488777 | romiplostim |
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| Male |
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| Black or African American |
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| Hispanic or Latino |
|
One-sided test |
| No |
| Superiority or Other |
| Satterhwaite t-test | 0.7133 | One-sided test | No | Superiority or Other |
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