A trial of apixaban to prevent blood clots in people with myeloma (TiMM)

The trial team found that it was safe for people with myeloma to take apixaban, and that it should be possible to run a larger trial.

Trial design
This trial was for people who had been recently diagnosed with myeloma. The doctor assessed their risk of developing a blood clot. They were put into a treatment group at random:

• those who had a high risk of developing a blood clot had either apixaban or enoxaparin
• those who had a standard risk of developing a blood clot had either apixaban or aspirin

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. 

The people taking part had the first blood thinning treatment on the day they started chemotherapy, and then every day for up to 6 months after that. They saw the doctor every 3 weeks, on the same day they had chemotherapy.

Results
A total of 10 people joined the trial, 2 who had high risk and 8 who had standard risk of developing a blood clot. 

The 2 people at high risk were put into 1 of 2 treatment groups at random:

• 2 people had apixaban
• 0 people had enoxaparin

The 8 people with standard risk were also put into 1 of 2 treatment groups at random:

• 4 people had apixaban
• 4 people had aspirin

 The research team found that no one taking part developed a serious blood clot. And no one had any major bleeding problems. But it’s hard to draw any firm conclusions because of the small number of people taking part. This is especially true in the high risk group.

Focus groups
The research team held a focus group meeting and asked 5 patients and 2 carers about things such as:

• what they knew about the risk of developing blood clots with myeloma
• what they thought about taking part in clinical trials in general
• what they thought about taking part in this trial in particular
• how they felt about taking part in more than one trial at the same time

The results showed that people didn’t know much about the increased risk of developing a blood clot with myeloma. The team found that people weren’t told much or given written information about it. Or if they had been told, they had been given so much other information they had forgotten.

People generally felt that it was good to take part in clinical trials. But some people felt it was more important to focus on treating the myeloma itself.

There was an issue with some other trials stating that people couldn’t join another trial at the same time. Patients are often happy to take part in more than one trial if they are allowed to. The research team felt that it would be useful for some trials to be more flexible about people also being part of another trial.

Side effects
Three people who took part had mild bleeding problems – two who were having aspirin and one who was having apixaban. No one had any serious bleeding problems.

Two people had a small blood clot where they had a small needle (cannula) in their arm to have chemotherapy. No one had a larger or more serious clot such as a deep vein thrombosis (DVT).

Future trials
The team found that it should be possible to run a larger trial looking at apixaban in more detail.

They asked 11 people if they’d like to join the TiMM trial and 10 people (91%) said they would. But they may need to look at who can join the trial (the eligibility criteria) and make a few changes, so it is easier for more people to take part.

Conclusion
The trial team concluded that they didn’t have any concerns about how safe apixaban is, or how well it works. And that, with a few changes, they should be able to run a larger trial to find out more about well it works. 

Where this information comes from    
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed ) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.