Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of apixaban to prevent blood clots in people with myeloma (TiMM)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is comparing apixaban with other blood thinning medications to see if it works as well and whether it has fewer side effects.
People with myeloma have an increased risk of developing blood clots and usually take medication for a short time to prevent this happening.
More about this trial
After being diagnosed with myeloma your doctor assesses your risk of developing a blood clot. They give you treatment for a short time until the risk has gone. This is usually about 6 months.
Which medication you have depends on what your risk is
- you have a low dose of aspirin if your risk is standard
- you have low molecular heparin, such as enoxaparin, if you are at a high risk
Both these medications prevent blood clots by thinning the blood.
Apixaban is a new type of blood thinning medication. Doctors have used it in other medical conditions to prevent blood clots. Researchers think apixaban might be just as good as aspirin or enoxaparin. And it might have fewer side effects. To find this out the researchers need to compare
- apixaban with aspirin
- apixaban with enoxaparin
This trial is a feasibility trial. The trial team want to know if it is possible to do a large clinical trial comparing apixaban with aspirin and enoxaparin.
The aims of this feasibility trial are to find
- how safe it is for people with myeloma to take apixaban
- how willing people are to take part in this trial
- how good apixaban might be in preventing blood clots
Who can enter
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
You may be able to join this trial if you go to King’s College Hospital NHS Foundation Trust and all of the following apply. You
- Have been newly diagnosed with myeloma
- Are willing to use reliable contraception if you or your partner could become pregnant
- Are at least 18 years old
You cannot join this trial if any of these apply. You
- Are already taking medication that reduces the risk of blood clots, such as warfarin, for any other medical condition
- Have another medical condition that might increase your risk of bleeding for example stomach ulcer or ulcers of the food pipe (oesophagus)
- Have recently had a major bleeding episode such as a stroke
- Have recently had major surgery
- Have an
hereditarydisorder that means you are unable to absorb or breakdown lactose
- Aren’t able to have aspirin or enoxaparin
- Are sensitive to apixaban, aspirin, enoxaparin or any of their ingredients
- Take other medication that affects body substances called CYP enzymes
- Are breastfeeding or pregnant
This is a phase 4 trial. The trial team need 40 people to join.
It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
People who have a high risk of developing a blood clot have either enoxaparin or apixaban.
People who have a standard risk of developing a blood clot have either aspirin or apixaban.
You have enoxaparin as an injection under the skin once a day.
Aspirin is a tablet you have once a day with food.
Apixaban is a tablet you have twice a day.
You continue with treatment until your doctor decides that you no longer need it. This is usually within 6 months.
Quality of life
The trial team ask you to fill out a questionnaire every 3 to 4 weeks for 6 months. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
The trial team will ask for extra samples of your blood during the trial. You don’t have to agree to this. You can still take part in the trial.
All the trial visits are on the same day as your routine clinic appointments. So there are no extra visits if you take part but you will be at the hospital a bit longer.
You see the doctor to have a physical examination and blood tests before taking part.
During treatment you see the doctor every 3 weeks for blood tests and to see how you are.
About 10 to 20 days after stopping treatment a member of the trial team will phone you to see how you are.
The most common side effects of apixaban are
- nose bleed
The most common side effects of aspirin are
- sensitivity which may cause skin rashes, itching, wheezing, coughing or difficulty breathing
- feeling or being sick
- ringing in the ears (tinnitus)
- pain or discomfort in your stomach or lower chest after eating
The most common side effects of enoxaparin are
- an increase in the number of platelets in the blood
- a change to the way the liver works
- itchy skin, rash
- swelling, pain and itching at the injection site
Your doctor will talk to you about the side effects before you agree to take part in the trial.
How to join a clinical trial
Professor Roopen Arya
King’s College Hospital NHS Foundation Trust,
National Institute for Health Research (NIHR)
NIHR Clinical Research Network: Cancer