Multiple myeloma MedDRA version: 18.1 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864 MedDRA version: 18.1 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Eliquis
Product Name: Apixaban
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: APIXABAN
CAS Number: 503612-47-3
Sponsors
King’s College Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients >18 years of age, newly diagnosed with multiple myeloma at King’s College Hospital NHS Foundation Trust. (2) Able to give written consent to participate. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
Exclusion criteria: (1) Pregnant and breast-feeding women, based on a verbal history from the patient. (2) Hypersensitivity to the active substances or to any of the excipients being used in this study. (3) Patients unable to be prescribed aspirin or enoxaparin as standard care. (4) Patients already prescribed anticoagulant or anti-platelet therapy for other indications. (5) Hypersensitivity to the active substance or to any of the excipients of apixaban; i.e. active clinically significant bleeding; hepatic disease associated with coagulopathy and clinically relevant bleeding risk; lesion or condition if considered a significant risk for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasm at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular neoplasms or major intraspinal or interacerebral vascular abnormalities; concomitant treatment with any other anticoagulant agent. (6) Patients receiving concomitant systemic treatment with strong inhibitors of both CYP3A4 and P-gp, such as azole-antimycotics (e.g., ketoconazole, itraconazole, voriconazole and posaconazole) and HIV protease inhibitors (e.g., ritonavir). (7) Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety of apixaban as a thromboprophylactic agent in the newly diagnosed myeloma population; Secondary Objective: - Recruitment rate from eligible population to the study - Venous thromboembolism event rate on different modes of thromboprohylaxis ; Primary end point(s): - Bleeding as a result of thromboprophylaxis, requiring cessation of prophylactic therapy - Objectively diagnosed thromboembolic event ;Timepoint(s) of evaluation of this end point: The primary outcomes will be measured during and 10 days post IMP administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
United Kingdom
Contacts
Public ContactProfessor Roopen Arya
King’s College Hospital NHS Foundation Trust
Outcome results
None listed