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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Hospitalized patients with histologically or cytologically confirmed diagnosis of solid tumor malignancy, lymphoma, or multiple myeloma and who are at high risk for a venous thromboembolism will be randomized to standard dose versus intermediate dose enoxaparin.
In a phase II trial, high risk hospitalized cancer patients will be enrolled and randomized to standard dose enoxaparin versus intermediate dose (weight adjusted) enoxaparin thromboprophylaxis. Study subjects will be administered enoxaparin during hospitalization in a double-blinded manner. Following completion of 14 days, the study arms will be unblinded and lower extremity ultrasound performed on the standard dose enoxaparin arm in order to more accurately determine the overall cumulative incidence of thrombosis in this group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Standard Dose Enoxaparin | Active Comparator | Participants will receive Enoxaparin 40 mg subcutaneously once daily. On study Enoxaparin will be administered for up 14 days during hospitalization. After the day 14 assessment, treatment arms will be un-blinded in order to appropriately schedule a bilateral lower extremity ultrasound for participants enrolled onto Arm A at day 17. |
|
| B: Weight Adjusted Enoxaparin | Active Comparator | Participants will receive Enoxaparin at 1mg/kg subcutaneously once daily with maximum dose of 100 mg daily. Participants who weigh more than 100kg will be capped at 100mg. On study Enoxaparin will be administered for up 14 days during hospitalization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Venous Thromboembolic Events (VTE) in Standard Dose Enoxaparin Arm at 17 Days | To investigate the numbers of VTE in hospitalized cancer patients receiving standard dose | 17 days only measured in Arm A (Standard dose enoxaparin) |
| Number Participants With Major Hemorrhage | Number of major hemorrhage in weight-adjusted enoxaparin arm and standard-dose enoxaparin arm | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Symptomatic Venous Thromboembolic Events (VTE) | Comparing number of symptomatic VTE (data collected prior to unblinding) for the standard dose (Arm A) versus intermediate dose enoxaparin (Arm B). | 14 days |
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Inclusion Criteria:
Participants must have histologically or cytologically confirmed diagnosis of solid tumor malignancy, lymphoma or multiple myeloma.
Cancer diagnosis or received treatment (chemotherapy or radiotherapy) for malignancy within the previous 6 months
One or more Padua-based risk factor:
Age ≥ 18 years
Life expectancy of greater than 30 days
Platelet count ≥ 100,000/mcL
Creatinine < 1.5 mg/dL or estimated creatinine clearance ≥ 50 mL/min/1.73 m2
Ability to understand and the willingness to sign a written informed consent document
Weight between 50kg to 130 kg.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Zwicker, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States | ||
| Cleveland Clinic Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32442298 | Derived | Zwicker JI, Roopkumar J, Puligandla M, Schlechter BL, Sharda AV, Peereboom D, Joyce R, Bockorny B, Neuberg D, Bauer KA, Khorana AA. Dose-adjusted enoxaparin thromboprophylaxis in hospitalized cancer patients: a randomized, double-blinded multicenter phase 2 trial. Blood Adv. 2020 May 26;4(10):2254-2260. doi: 10.1182/bloodadvances.2020001804. |
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| ID | Title | Description |
|---|---|---|
| FG000 | A: Standard Dose Enoxaparin | Participants will receive Enoxaparin 40 mg subcutaneously once daily. On study Enoxaparin will be administered for up 14 days during hospitalization. After the day 14 assessment, treatment arms will be un-blinded in order to appropriately schedule a bilateral lower extremity ultrasound for participants enrolled onto Arm A at day 17. Enoxaparin |
| FG001 | B: Weight Adjusted Enoxaparin | Participants will receive Enoxaparin at 1mg/kg subcutaneously once daily with maximum dose of 100 mg daily. Participants who weigh more than 100kg will be capped at 100mg. On study Enoxaparin will be administered for up 14 days during hospitalization. Enoxaparin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A: Standard Dose Enoxaparin | Participants will receive Enoxaparin 40 mg subcutaneously once daily. On study Enoxaparin will be administered for up 14 days during hospitalization. After the day 14 assessment, treatment arms will be un-blinded in order to appropriately schedule a bilateral lower extremity ultrasound for participants enrolled onto Arm A at day 17. Enoxaparin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Evaluated for VTE and safety |
| 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 | Total Number of Venous Thromboembolic Events (VTE) in Standard Dose Enoxaparin Arm at 17 Days | To investigate the numbers of VTE in hospitalized cancer patients receiving standard dose | All patients who were randomized to the standard dose of enoxaparin | Posted | Number | participants | 17 days only measured in Arm A (Standard dose enoxaparin) |
|
|
All adverse events data were collected from the time of the first dose (Day 1) of the study treatment, throughout the study, and until the final study visit (Day 14)
All serious adverse events that occur after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment must be reported to the Overall Principal Investigator.
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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 | A: Standard Dose Enoxaparin | Participants will receive Enoxaparin 40 mg subcutaneously once daily. On study Enoxaparin will be administered for up 14 days during hospitalization. After the day 14 assessment, treatment arms will be un-blinded in order to appropriately schedule a bilateral lower extremity ultrasound for participants enrolled onto Arm A at day 17. Enoxaparin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Infections | Infections and infestations | CTCAE) version 4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Zwicker, Division of Thrombosis and Haemostasis, Division of Hematology and Oncology | Beth Israel Deaconess Medical Center, Harvard Medical School | 617.667.9299 | jzwicker@bidmc.harvard.edu |
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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 | Aug 28, 2018 | Mar 25, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| Cleveland |
| Ohio |
| 44195 |
| United States |
| BG001 | B: Weight Adjusted Enoxaparin | Participants will receive Enoxaparin at 1mg/kg subcutaneously once daily with maximum dose of 100 mg daily. Participants who weigh more than 100kg will be capped at 100mg. On study Enoxaparin will be administered for up 14 days during hospitalization. Enoxaparin |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Evaluated for VTE and safety | Count of Participants | Participants |
|
| Race (NIH/OMB) | Evaluated for VTE and safety | Count of Participants | Participants |
|
| Region of Enrollment | Evaluated for VTE and safety | Count of Participants | Participants |
|
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| Primary | Number Participants With Major Hemorrhage | Number of major hemorrhage in weight-adjusted enoxaparin arm and standard-dose enoxaparin arm | Posted | Count of Participants | Participants | 14 days |
|
|
|
| Secondary | Number of Symptomatic Venous Thromboembolic Events (VTE) | Comparing number of symptomatic VTE (data collected prior to unblinding) for the standard dose (Arm A) versus intermediate dose enoxaparin (Arm B). | The analysis data set is comprised of evaluated patients. | Posted | Count of Participants | Participants | 14 days |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 10 |
| 23 |
| EG001 | B: Weight Adjusted Enoxaparin | Participants will receive Enoxaparin at 1mg/kg subcutaneously once daily with maximum dose of 100 mg daily. Participants who weigh more than 100kg will be capped at 100mg. On study Enoxaparin will be administered for up 14 days during hospitalization. Enoxaparin | 0 | 24 | 0 | 24 | 6 | 24 |
| Anemia | Blood and lymphatic system disorders | CTCAE) version 4.0 | Systematic Assessment |
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| Platelets Count Decrease | Investigations | CTCAE) version 4.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE) version 4.0 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE) version 4.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | CTCAE) version 4.0 | Systematic Assessment |
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| Distal deep vein thrombosis | Vascular disorders | CTCAE) version 4.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE) version 4.0 | Systematic Assessment |
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| Pain | General disorders | CTCAE) version 4.0 | Systematic Assessment |
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| Pain - extremeties | Musculoskeletal and connective tissue disorders | CTCAE) version 4.0 | Systematic Assessment |
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| Pulmonary Embolism | Vascular disorders | CTCAE) version 4.0 | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | CTCAE) version 4.0 | Systematic Assessment |
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| Neutrophil Count Decrease | Investigations | CTCAE) version 4.0 | Systematic Assessment |
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| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | CTCAE) version 4.0 | Systematic Assessment |
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| GI-Hemorrhage | Gastrointestinal disorders | CTCAE) version 4.0 | Systematic Assessment | One participant randomly assigned to fixed-dose enoxaparin developed a grade 2 laryngeal bleed occurring several days after completing the trial. the last dose of enoxaparin. |
|
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| D002241 |
| Carbohydrates |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
|