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Low recruitment
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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Interventional, no-randomized, open-label, and single arm multicentre study of apixaban for the prevention of thromboembolic events during induction therapy in transplant-eligible patients with newly diagnosed multiple myeloma who receive bortezomib, thalidomide, and dexamethasone (VTD) during the induction phase of therapy prior to autologous stem cell transplantation (ASCT). The current study is designed to evaluate the efficacy and safety of apixaban during the induction period. Efficacy will be defined as a composite endpoint of acute symptomatic proximal and distal deep venous thrombosis, pulmonary embolism, VTE related deaths, and acute ischemic stroke.
This study is designed to test the efficacy and safety of the oral anti factor Xa apixaban 2.5 mg given twice daily as a prophylaxis of VTE in transplant-eligible patients with multiple myeloma during the induction therapy with VTD.
Induction therapy prior to ASCT will consist in no less than 4 and no more than 6 cycles of VTD, depending on treatment response. Duration of each cycle is 4 weeks if there is not any disease or treatment-related complication; therefore, treatment duration will be around 4-6 months. Daily Prophylaxis with apixaban will continue up to a maximum of 14 days after the last dose of thalidomide. In addition, there will be an additional observation period of 14 (± 7) days, starting the day after the last dose of study medication (until 28 days after the end of the last cycle of VTD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban (single arm) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban 2.5 MG | Drug | Apixaban will be started simultaneously with anti myeloma treatment on day 1 of cycle 1 of VTD, and continues for 4 to 6 months depending on the number of induction cycles administered to the patient |
| Measure | Description | Time Frame |
|---|---|---|
| Venous thromboembolism (VTE)- related death | i.e. death for which VTE can not be excluded as a cause | Cycle 1 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Venous thromboembolism (VTE)- related death | i.e. death for which VTE can not be excluded as a cause | Cycle 2 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Venous thromboembolism (VTE)- related death | i.e. death for which VTE can not be excluded as a cause | Cycle 3 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Venous thromboembolism (VTE)- related death | i.e. death for which VTE can not be excluded as a cause | Cycle 4 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Venous thromboembolism (VTE)- related death | i.e. death for which VTE can not be excluded as a cause | Cycle 5 Day 1(each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Venous thromboembolism (VTE)- related death | i.e. death for which VTE can not be excluded as a cause | Cycle 6 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding event | Defined as a bleeding event that is acute clinically overt bleeding accompanied by one or more of the following:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier de la Rubia | Hospital Doctor Peset | Study Director |
| Samuel Romero | Hospital Universitario y Politecnico La Fe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico Universitario | Valencia | 46010 | Spain | |||
| Hospital Universitario Doctor Peset |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C522181 | apixaban |
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Clinical trial with a single arm
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| Venous thromboembolism (VTE)- related death | i.e. death for which VTE can not be excluded as a cause | Cycle 4 Day 29 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Venous thromboembolism (VTE)- related death | i.e. death for which VTE can not be excluded as a cause | Cycle 6 Day 29 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Venous thromboembolism (VTE)- related death | i.e. death for which VTE can not be excluded as a cause | Cycle 4 Day 43 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Venous thromboembolism (VTE)- related death | i.e. death for which VTE can not be excluded as a cause | Cycle 6 Day 43 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Venous thromboembolism (VTE)- related death | i.e. death for which VTE can not be excluded as a cause | 14 days after last dose of apixaban |
| Symptomatic deep-vein thrombosis (DVT) | Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness | Cycle 1 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Symptomatic deep-vein thrombosis (DVT) | Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness | Cycle 2 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Symptomatic deep-vein thrombosis (DVT) | Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness | Cycle 3 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Symptomatic deep-vein thrombosis (DVT) | Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness | Cycle 4 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Symptomatic deep-vein thrombosis (DVT) | Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness | Cycle 5 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Symptomatic deep-vein thrombosis (DVT) | Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness | Cycle 6 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Symptomatic deep-vein thrombosis (DVT) | Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness | Cycle 4 Day 29 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Symptomatic deep-vein thrombosis (DVT) | Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness | Cycle 6 Day 29 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Symptomatic deep-vein thrombosis (DVT) | Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness | Cycle 4 Day 43 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Symptomatic deep-vein thrombosis (DVT) | Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness | Cycle 6 Day 43 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Symptomatic deep-vein thrombosis (DVT) | Lower extremity DVT: erythema (redness of the skin), warmth, pain, swelling, tenderness | 14 days after last dose of apixaban |
| Pulmonary embolism (PE) | Pleuritic chest pain, dyspnea (shortness of breath), cough, hemoptysis (expectoration of blood or blood-stained sputum), syncope (fainting), lightheadedness/dizziness, tachypnea (rapid breathing), tachycardia (fast heart rate). | Cycle 1 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Pulmonary embolism (PE) | Pleuritic chest pain, dyspnea (shortness of breath), cough, hemoptysis (expectoration of blood or blood-stained sputum), syncope (fainting), lightheadedness/dizziness, tachypnea (rapid breathing), tachycardia (fast heart rate). | Cycle 2 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Pulmonary embolism (PE) | Pleuritic chest pain, dyspnea (shortness of breath), cough, hemoptysis (expectoration of blood or blood-stained sputum), syncope (fainting), lightheadedness/dizziness, tachypnea (rapid breathing), tachycardia (fast heart rate). | Cycle 3 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Pulmonary embolism (PE) | Pleuritic chest pain, dyspnea (shortness of breath), cough, hemoptysis (expectoration of blood or blood-stained sputum), syncope (fainting), lightheadedness/dizziness, tachypnea (rapid breathing), tachycardia (fast heart rate). | Cycle 4 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Pulmonary embolism (PE) | Pleuritic chest pain, dyspnea (shortness of breath), cough, hemoptysis (expectoration of blood or blood-stained sputum), syncope (fainting), lightheadedness/dizziness, tachypnea (rapid breathing), tachycardia (fast heart rate). | Cycle 5 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Pulmonary embolism (PE) | Pleuritic chest pain, dyspnea (shortness of breath), cough, hemoptysis (expectoration of blood or blood-stained sputum), syncope (fainting), lightheadedness/dizziness, tachypnea (rapid breathing), tachycardia (fast heart rate). | Cycle 6 Day 1 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Pulmonary embolism (PE) | Pleuritic chest pain, dyspnea (shortness of breath), cough, hemoptysis (expectoration of blood or blood-stained sputum), syncope (fainting), lightheadedness/dizziness, tachypnea (rapid breathing), tachycardia (fast heart rate). | Cycle 4 Day 29 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Pulmonary embolism (PE) | Pleuritic chest pain, dyspnea (shortness of breath), cough, hemoptysis (expectoration of blood or blood-stained sputum), syncope (fainting), lightheadedness/dizziness, tachypnea (rapid breathing), tachycardia (fast heart rate). | Cycle 6 Day 29 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Pulmonary embolism (PE) | Pleuritic chest pain, dyspnea (shortness of breath), cough, hemoptysis (expectoration of blood or blood-stained sputum), syncope (fainting), lightheadedness/dizziness, tachypnea (rapid breathing), tachycardia (fast heart rate). | Cycle 4 Day 43 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Pulmonary embolism (PE) | Pleuritic chest pain, dyspnea (shortness of breath), cough, hemoptysis (expectoration of blood or blood-stained sputum), syncope (fainting), lightheadedness/dizziness, tachypnea (rapid breathing), tachycardia (fast heart rate). | Cycle 6 Day 43 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Pulmonary embolism (PE) | Pleuritic chest pain, dyspnea (shortness of breath), cough, hemoptysis (expectoration of blood or blood-stained sputum), syncope (fainting), lightheadedness/dizziness, tachypnea (rapid breathing), tachycardia (fast heart rate). | 14 days after last dose of apixaban |
| Asymptomatic proximal DVT as detected by systematic compression ultrasound | Diagnostic assessment of DVT. Presence of any one of the following will be considered diagnostic for the presence of DVT:
| Cycle 4 Day 43 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Asymptomatic proximal DVT as detected by systematic compression ultrasound | Diagnostic assessment of DVT. Presence of any one of the following will be considered diagnostic for the presence of DVT:
| Cycle 6 Day 43 (each cycle is 28 days. Treatment will finish on cycle 4 or 6. Treatment with Apixaban will continue until 14 days after cycle 4/6) |
| Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 4/ 6 Day 29, Cycle 4/6 Day 43, Day 14 after end of treatment (each cycle is 28 days. Treatment with Apixaban will continue until 14 days after cycle 4 or 6) |
| Clinically relevant non-major bleeding event | Defined as a bleeding event that is:
| Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 4/ 6 Day 29, Cycle 4/6 Day 43, Day 14 after end of treatment (each cycle is 28 days. Treatment with Apixaban will continue until 14 days after cycle 4 or 6) |
| Fatal Bleeding Event | Defined as a bleeding event that determines is the primary cause of death or contributes directly to death. | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 4/ 6 Day 29, Cycle 4/6 Day 43, Day 14 after end of treatment (each cycle is 28 days. Treatment with Apixaban will continue until 14 days after cycle 4 or 6) |
| Liver injury event | Potential or suspected cases of liver injury including but not limited to liver test abnormalities (elevation of ALT, AST, GGT, alkaline phosphatase and total bilirrubin), jaundice, hepatitis or cholestasis events. | Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 4/ 6 Day 29, Cycle 4/6 Day 43, Day 14 after end of treatment (each cycle is 28 days. Treatment with Apixaban will continue until 14 days after cycle 4 or 6) |
| Serious adverse events | A Serious Adverse Event is any untoward medical occurrence that:
| Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 4/ 6 Day 29, Cycle 4/6 Day 43, Day 14 after end of treatment (each cycle is 28 days. Treatment with Apixaban will continue until 14 days after cycle 4 or 6) |
| Symptomatic DVT or PE occurring during the 90 days of follow-up period | Symptomatic DTV or PE as defined aforementioned, assessed 90 days after the last dose of the study drug. | Day +90 follow-up |
| Death occurring during the 90 days of follow-up period | All cause of mortality occurring during the 90 days after the last dose of the study drug. | Day +90 follow-up |
| Valencia |
| 46017 |
| Spain |
| Hospital Universitario y Politécnico La Fe | Valencia | 46026 | Spain |
| Hospital General Universitario | Valencia | Spain |
| D054219 |
| Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| 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 |