Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at bortezomib, adriamycin and dexamethasone as the first treatment for myeloma (PADIMAC)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a combination of the drugs bortezomib, adriamycin and dexamethasone (PAD) for myeloma. It is for people who have not yet had any other treatment for myeloma.
We know from research that people who have a very good response to their initial chemotherapy can stay free of myeloma (be in
Other studies have shown that people who have a drug called bortezomib alongside chemotherapy as the first treatment for myeloma can have a very good response. Myeloma disappears (complete remission) in more people who have bortezomib with chemotherapy than in people who have chemotherapy alone.
Doctors will assess each person’s response to treatment. If the myeloma goes into remission, they will not have a stem cell transplant straight away – they may have this type of treatment when they relapse. People who don’t have such a good response will have a stem cell transplant straight after PAD.
The aim of this trial is to see if people who have a good response to PAD can safely wait to have a stem cell transplant.
Who can enter
You may be able to enter this trial if you
- Have myeloma that is causing symptoms and you have not had any treatment yet
- Would be able to have high dose chemotherapy and a stem cell transplant
- Have satisfactory blood test results
- Are well enough to take part and do not need complete care (you have a performance status between 0 and 3) - you may be able to take part if you need complete care, but this is only because of your myeloma
- Are willing to use reliable contraception during the trial and for 6 months afterwards if there is any chance you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have damage to your nerves (peripheral neuropathy) unless it is very mild
- Are known to be allergic to drugs called mannitol or boron
- Have a history of lung disease or your heart is not working very well (the trial doctors can advise you about this)
- Have HIV, hepatitis B or hepatitis C
- Have any other condition which the trial doctor thinks could affect you taking part
- Are pregnant or breastfeeding
This is a phase 2 trial. It will recruit about 120 people at different hospitals in the UK.
Everybody taking part has bortezomib, adriamycin and dexamethasone (PAD). The trial doctors recommend you have a central line put in before you start treatment.
You have treatment in 21 day (3 week) cycles of treatment. In each cycle, you have
- Bortezomib as an injection under your skin (subcutaneous) on days 1, 4, 8 and 11
- Adriamycin through a continuous drip or separate injections into your central line on days 1 to 4
- Dexamethasone tablets on days 1 to 4 (In the first cycle of treatment, you have dexamethasone tablets on days 8 to 11 and 15 to 18 as well)
If you have a bad skin reaction to the subcutaneous injection, you can have bortezomib as an injection into a vein.
You have between 4 and 6 cycles of treatment. The trial doctors will then see how your myeloma has responded.
If the myeloma has not responded to the PAD treatment at all, or has not responded well enough for you to be able to have a stem cell transplant, you will leave the trial and your specialist will talk to you about other treatment options.
If the myeloma has responded well enough to have a stem cell transplant, you will start chemotherapy and growth factors within about 6 weeks. You have a chemotherapy drug called cyclophosphamide. You then have daily injections of a growth factor called G-CSF. This makes your
If your myeloma did show some response to PAD treatment, but not enough for you to delay having a stem cell transplant (a partial response), you will have your transplant at this point. You have a high dose of a chemotherapy drug called melphalan. This kills both the myeloma cells and your healthy bone marrow cells. So you then have your own stem cells back through a drip into your central line. The cells find their way into your bone marrow and start making blood cells again.
If your myeloma had completely disappeared (complete response), or almost disappeared (very good partial response) after PAD, you will not have a stem cell transplant at this point. You will still have chemotherapy and stem cells collected, but these will be frozen and stored until you need them. The doctors will monitor you closely and you may have a transplant when your myeloma comes back.
You see the trial doctors and have some tests before you start treatment. The tests include
- Physical examination
- Blood and urine tests
- Heart trace (
- Heart scan (
echocardiogram) or MUGA
- Bone marrow test
You have PAD treatment for between 12 and 18 weeks. During this time, you go to hospital regularly for treatment and check ups. If you have a stem cell transplant, you will be in hospital for 3 to 4 weeks.
After your transplant (or after your stem cell collection if you don’t have a transplant straight away) you go to hospital for check ups
- After 100 days
- After 6 months, 1 year, 18 months, 2 years and then the same as if you were having routine care
Throughout the trial, you have regular blood tests and more bone marrow tests if needed. Your doctor may also want you to have other tests and scans. You are unlikely to have more hospital visits than you would if you were having treatment for myeloma but not taking part in the trial.
The most common side effects of bortezomib include
- Tiredness (fatigue)
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Pain in your tummy (abdomen) with diarrhoea or constipation
- Weight loss
- Pain or numbness and tingling in your hands and feet (peripheral neuropathy)
- High temperature (fever)
Dexamethasone can cause problems such as mood changes, difficulty sleeping, an increase in blood pressure and in blood sugar levels.
When you have a central line, you may get an infection. There is also a possibility of a blood clot forming.
If you have a stem cell transplant, you will have a drop in your blood cell count, which increases your risk of infection. During this time, you may also have a poor appetite, a sore mouth and diarrhoea. Most people start to feel better as their blood counts improve.
On this website there is more information about
How to join a clinical trial
Dr Kwee L Yong
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)