E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028228 |
E.1.2 | Term | Multiple myeloma |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049909 |
E.1.2 | Term | Venous thromboembolism prophylaxis |
E.1.2 | System Organ Class | 100000004865 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Safety of apixaban as a thromboprophylactic agent in the newly diagnosed myeloma population |
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E.2.2 | Secondary objectives of the trial |
- Recruitment rate from eligible population to the study
- Venous thromboembolism event rate on different modes of thromboprohylaxis
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Evaluation of the increased thrombotic risk in the myeloma population v.5 08/10/2015
In order to understand how the baseline VTE risk differs in a newly diagnosed myeloma population, a control group of patients will additionally be recruited, who will be asked for a 30mL blood sample, the results from which will be compared to the baseline results from the subjects in the study. Recruited controls will be age, gender and ethnicity matched to the subjects recruited.
Understanding the patient perspective - v.5 08/10/2015
A key objective of this feasibility trial is to understand patient and carers views about consenting to such a study and their experiences of taking part. Key issues being, one medication form being parenteral, the other an oral tablet, and the fact that patients may already be consented to other clinical trials at the same time for their myeloma treatment, so how would they feel about entering a further study, at the same time. Understanding these issues will be key, if a multi-centre trial is conducted in the future.
Two discrete pieces of qualitative work are planned, in the form of focus groups. One before this feasibility clinical trial begins and one at the end of the study. The results from the focus group discussions will be published, but will not be captured for the specific study report. |
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E.3 | Principal 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.
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Bleeding as a result of thromboprophylaxis, requiring cessation of prophylactic therapy
- Objectively diagnosed thromboembolic event
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary outcomes will be measured during and 10 days post IMP administration |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial will be closed when all participants have made their final follow up visit, the data entered into the database and all queries resolved and the database locked. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |