A trial looking at DNA vaccine therapy after stem cell transplant for myeloma (MMIFTT)

Please note this trial is no longer recruiting patients.

This trial is looking at DNA vaccine therapy after a stem cell transplant to help treat people with myeloma.

Myeloma is a type of cancer that develops from cells in the bone marrow called plasma cells. Most patients will have chemotherapy for myeloma and this can get the cancer under control (remission). But the cancer is likely to come back (relapse) or become more active over time.

Some patients have a stem marrow transplant using their own stem cells. This is called an ‘autologous’ transplant. But even a transplant may not work in all patients and sometimes the cancer may come back.

This trial is looking into using a DNA vaccine, which is made from a sample of the patient’s cancer cells. The patients will have this vaccine as injections after their transplant. The researchers hope that the vaccine will increase the body’s ability to fight cancer if it comes back. The aim of this trial is to find out if

It is possible to make the DNA vaccine and to vaccinate patients
The patient’s immune system can recognise and kill the cancer cells

Recruitment

Start 01/03/2004

End 14/12/2011

Phase

Phase 1/2

Who can enter

You can enter this trial if

You have multiple myeloma and have had high dose chemotherapy followed by an stem cell transplant using your own stem cells
Your myeloma cells are available and can be used for making a vaccine. (Your consultant will be able to tell you if this is the case)
Abnormal protein from the cancer cells can be taken from your blood or was stored before you had your transplant
You have satisfactory blood tests
You are well enough to take part in this trial and to travel to the trial centre (hospital) for vaccination and follow up visits
You are willing to use adequate contraception if there is a chance that you or your partner could become pregnant
You are at least 18 years

You cannot enter this trial if you

Have heavy or light chain multiple myeloma
Have had chemotherapy in the last 3 months
Are having any other kind of treatment for your cancer except thalidomide or similar treatments
Have any other type of cancer
Have any medical condition or illness that means you cannot have the vaccine therapy in this trial
Are having steroid treatment, except steroids through an inhaler
Are HIV positive
Are a known carrier of hepatitis B or hepatitis C

Trial design

This trial will recruit 20 patients. Patients at the recruiting hospitals will be asked to take part by their doctor.

Before you take part in this trial, you will have standard treatment for your myeloma. In your particular situation, this includes high dose chemotherapy followed by a stem cell transplant using your own stem cells.

The researchers will take a sample of your cancer from when you were first diagnosed. They will use genetic material from this sample and combine it with a form of the tetanus vaccine to make the DNA vaccine.

Nine months after your transplant you will start your vaccine therapy. You will have this as an injection into a muscle of your arm or buttock. You will have 6 injections in total, over a period of 3 months.

You may have further vaccination injections if your myeloma comes back and steroid treatment or chemotherapy is not appropriate for you. Your doctor will discuss this with you if necessary.

Hospital visits

Before you start your treatment a doctor will examine you and do various tests. These will include

Bone marrow test
Urine test
Blood tests

Some of these may be repeated during and after your treatment. You will have these tests as part of your standard treatment. The only extra tests you have as part of this trial will be extra blood tests. Your treatment is intensive, whether you take part in this trial or not. You will be in hospital on and off for some months. You will probably have your vaccine injections as an outpatient on the day care ward. You will stay on the day care ward for at least one hour after you injection while the nursing staff will keep an eye on you. Then you should be able to go home.

After your vaccination treatment, you will need to travel to the trial centre for follow up appointments. You will see a trial doctor about every month at first, then every 3 months for about 9 months.

Side effects

Vaccine therapy is a new and experimental treatment. The researchers do not think the side effects of your treatment will be made worse as a result of having vaccine therapy. You may have mild swelling at your injection site, feel tired and have flu like symptoms. Muscle pains are less likely. There is information about the side effects of a stem cell transplant on CancerHelp UK.