Thromboprophylaxis in newly diagnosed Multiple Myeloma (TiMM)
Research type
Research Study
Full title
The role of apixaban, aspirin and enoxaparin as Thromboprophylaxis in patients newly diagnosed with Multiple Myeloma - an open label randomised-controlled feasibility study (TiMM)
IRAS ID
171545
Contact name
Roopen Arya
Contact email
Sponsor organisation
King's College Hospital NHS Foundation Trust
Eudract number
2015-002668-18
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
It is well recognised that cancer increases the risk of developing a clot in the leg (deep vein thrombosis) or a clot in the blood vessels supplying the lungs (pulmonary embolism). Some cancers increase this risk more so than others, with multiple myeloma (a form of cancer of the blood) particularly associated with an increased risk.
Doctors minimise this risk, by prescribing low dose aspirin or low molecular weight heparin – a injection based anti-clot treatment (depending on the risk of developing the clot). In the initial months following diagnosis, most patients are considered as high risk of developing these clots and so invariably are prescribed a low molecular weight heparin. This has significant implications for patients, as they have to inject the medicine every day which many patients report finding difficult.
In recent years, a new class of anti-clot medicine has become available for use in clinical practice called direct factor Xa inhibitors, e.g. apixaban. Large clinical trials have shown that they are just as safe and effective as low molecular weight heparin in preventing blood clots for patients undergoing elective orthopaedic surgery. These agents are available as tablets and provide a neat solution to overcoming the shortcomings of low molecular weight heparin and having to inject every day.
To date, very little work has been done, evaluating whether it would be appropriate to use these agents in patients diagnosed with multiple myeloma for both high and low risk patients. This study aims to explore the safety and effectiveness of apixaban as clot-prevention treatment in the myeloma population during the first 6 months following diagnosis and compare outcomes to the current standard of care of aspirin and low molecular weight heparin.
The feasibility study outlined in this proposal will inform a multi-centre clinical trial, if apixaban is found to be beneficial.REC name
London - Central Research Ethics Committee
REC reference
15/LO/1319
Date of REC Opinion
4 Dec 2015
REC opinion
Further Information Favourable Opinion