A trial looking at different treatments including carfilzomib for people with myeloma (CARDAMON)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Myeloma

Status:

Closed

Phase:

Phase 2

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.

More about this trial

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:

induction treatment
timing of a stem cell transplant
maintenance treatment

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:

how well carfilzomib, cyclophosphamide and dexamethasone work as an induction treatment for people with myeloma
whether it is best for people to have a stem cell transplant after induction treatment, or further carfilzomib, cyclophosphamide and dexamethasone (consolidation treatment)
how well carfilzomib works as a maintenance treatment for myeloma

Who can enter

You may be able to join this trial if your myeloma can be measured with one of the following

A blood test
A urine test
A bone marrow test that shows at least 30% plasma cells or shows 10% to 30% plasma cells and more than one area of plasmacytoma (an area of abnormal plasma cells in the bone or soft tissue) that measures at least 2cm across and can be seen on a scan

As well as the above, all of the following apply

You have myeloma that is causing symptoms and you have not had any treatment for this so far (you may be able to take part if you have had treatment with a group drugs called bisphosphonates, or you have had radiotherapy to treat symptoms, or you have had corticosteroids in the last 3 months)
Your doctor thinks that you will be able to have high dose chemotherapy and a transplant using your own stem cells
You are at least 18 years old
You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
You have satisfactory blood test results
You are willing to use reliable contraception during the trial and for 12 months afterwards if there is any chance that you or your partner could become pregnant

You cannot join this trial if any of these apply. You

Have had major surgery in the last 3 weeks apart from surgery to relieve symtoms of spinal cord compression or a broken (fractured) bone
Have had treatment for infection with antibiotics, antifungals or antiviral drugs in the last 7 days. You may be able to take part depite having this treatment, this depends on your situation, the trial team will discuss this with you
Are known to be HIV, hepatitis B or hepatitis C positive
Have had chest pain (angina) or a heart attack in the past 4 months or any other serious heart problem
Have high blood pressure or diabetes that hasn’t been controlled with medication in the last 2 weeks
Have had any other cancer in the last 3 years, unless it was very early stage and has been successfully treated (the trial team can advise you about this)
Have moderate to severe nerve damage
Are allergic to the drugs used in this trial
Have fluid on the lungs (pleural effusion ) or fluid on the abdomen (ascites ) that has needed draining in the last 2 weeks
Have any other serious medical condition that the trial team think could affect you taking part
Are pregnant or breastfeeding

Trial design

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:

one group of people have a transplant using their own stem cells
the other group have further treatment with carfilzomib, cyclophosphamide and dexamethasone (consolidation treatment)

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If you have a transplant you first have high dose melphalan to kill any remaining myeloma cells in your body. This also kills many of your normal bone marrow cells. You then have your stem cells returned to you through a drip into your vein. This takes about 4 hours. These stem cells find their way to the centre of your bones and begin to make blood cells after a few days or weeks.

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:

about 3 months after the stem cell transplant
after 4 cycles of chemotherapy

You might have a third scan. If needed you have this 6 months after starting your maintenance treatment.

Hospital visits

You see the doctors and have some tests before you start treatment. The tests include:

physical examination
blood tests
urine tests
heart scan (echocardiogram )
heart trace (ECG )
bone marrow test
x-ray
MUGA

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:

after your stem cell collection
after your consolidation treatment or transplant
after about 6 months of maintenance therapy
when your myeloma shows signs of growing again (relapse)

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.