
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at the use of carfilzomib and the timing of a stem cell transplant for people with myeloma. It is for people with myeloma who have not yet had any treatment. This trial is supported by Cancer Research UK.
Doctors treat newly diagnosed myeloma with a combination of drugs. If you are fit and well, you may have initial treatment for about 6 months (called induction chemotherapy). If this has worked, you may then have high dose chemotherapy followed by a transplant using your own stem cells. You then have further treatment to stop the cancer coming back for as long as possible (called maintenance treatment).
This trial is looking at 3 different areas in the treatment of myeloma:
The researchers are looking at a new combination of drugs for induction treatment. This includes the standard drugs cyclophosphamide (a type of chemotherapy), dexamethasone (a type of steroid) and a new drug called carfilzomib.
Carfilzomib is a type of biological therapy. It is a cancer growth blocker, it stops signals that cancer cells use to divide and grow.
Doctors are not sure if people who have had this new induction treatment should have a stem cell transplant straight away. Or have further treatment with the same drugs instead and keep their stem cells in storage to be used at a later time. To find this out, the researchers will compare 2 groups of people who have these different treatments. The trial team also want to know whether carfilzomib is useful as a maintenance treatment.
The aims of this trial are to find out:
You may be able to join this trial if your myeloma can be measured with one of the following
As well as the above, all of the following apply
You cannot join this trial if any of these apply. You
This is a phase 2 trial. The researchers need up to 280 people to join.
There are 3 parts to this trial. If your treatment is working and you are well enough you will go through parts 1, 2 and 3.
Induction treatment
The first part is induction treatment, this aims to get rid of as much of the myeloma in your bone marrow as possible.
You have treatment over 4 weeks. You have carfilzomib as a drip into a vein. You have it twice a week for 3 weeks then a week off. You have cyclophosphamide as a tablet. You have this once a week for 3 weeks then a week off.
Dexamethasone is also a tablet. You take it at home once at the start of each week. You can have cyclophosphamide and dexamethasone into your vein if you are not able to swallow tablets.
Each 4 week period is called a cycle of treatment and you have 4 cycles.
If your induction treatment has not worked well, you will no longer be part of the trial. Your doctor will discuss further treatment with you.
If your treatment has worked well enough you have your stem cells collected in preparation for your transplant. This happens about 4 to 8 weeks after your induction therapy. The trial doctor or nurse will give you more information about what a stem cell collection involves.
Consolidation treatment or a stem cell transplant
The second part of the trial is randomised. 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:
If you have consolidation treatment you have the same drugs as you had during induction treatment. The only difference is that the dose of dexamethasone will be lower. You have 4 cycles of treatment.
A few weeks after your transplant or consolidation treatment your doctor will assess you and decide whether the treatment has worked.
Maintenance therapy
If your treatment has worked well, you start treatment with carfilzomib on its own. The aim is to stop the cancer coming back for as long as possible, this is called maintenance therapy. You have it once a week for 3 weeks then have a week off. You may have up to 18 months of maintenance therapy.
PET-CT sub study
The team might ask you to join the PET-CT sub study. The team need a 120 people to join.
You have extra 2 PET-CT scans. The first before starting chemotherapy as part of the induction treatment. The second depending on your consolidation treatment at one of the following times:
You see the doctors and have some tests before you start treatment. The tests include:
You also have a scan to see whether your bones are affected by your myeloma. This might be an x-ray, MRI scan, CT scan or PET-CT scan . Your treatment team will tell you which particular scan you are going to have.
During induction treatment you go to the clinic twice a week for the first 3 weeks of each cycle. You see a doctor who will examine you and ask how you are. You have blood tests and sometimes urine tests. You might have a further scan after your induction treatment has finished.
You will be asked to keep a record of when you take your tablets and to take any remaining drugs or empty packaging to clinic with you.
You have another bone marrow test:
If you have a transplant you will be in hospital for some weeks. You will be looked after in a single room (being in isolation) for about 2 weeks. This is to protect you from the risk of infection. You may then stay for a further 1 or 2 weeks on the ward while you recover.
If you have consolidation treatment, your hospital visits will be similar to when you had your induction therapy.
During maintenance therapy you go to clinic and see a doctor once a month at the beginning of every treatment cycle.
After you finish treatment you go to hospital to have a check up every 2 to 3 months for the first year and every 6 months for the following 10 years.
The most common side effects of carfilzomib include:
The most common side effects of cyclophosphamide include
The most common side effects of dexamethasone include:
We have more information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Kwee Yong
Amgen
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
University College London (UCL)
This is Cancer Research UK trial number CRUK/13/032.
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.