A trial looking at DNA vaccine therapy after bone marrow transplant for myeloma (Educated donor lymphocytes, EDL)

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

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 or become more active (relapse) over time.

Some patients have a bone marrow transplant. The bone marrow is donated by a matched donor (usually a sister or brother), to try to cure the cancer. But even a transplant may not work in all patients and sometimes the cancer may come back. If this happens, the patient may have a drip of white blood cells called lymphocytes. Lymphocytes are part of the immune system and these are taken from the donor. This is called a ‘donor lymphocyte infusion’ and it aims to kill any remaining cancer cells.

This trial is looking into using a DNA vaccine which is made from a sample of the patient’s cancer. The donor will have this vaccine before their lymphocytes are collected. This kind of vaccine has been tested in about 30 patients and healthy donors and they have only had mild flu like symptoms. The researchers think that it is safe to give the vaccine to the donor and that there is no risk that this could cause cancer in the healthy donor. Hopefully, giving this vaccine to the donor will ‘educate’ their lymphocytes. When the donor’s lymphocytes are given to the patient, the patient’s immune system may be more able to recognise the cancer cells and kill them. The aim of this trial is to find out if

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

Recruitment

Start 01/03/2004

End 31/05/2013

Phase

Pilot

Who can enter

You can enter this trial if

You have myeloma and have had a matched allogeneic bone marrow transplant using your brother or sister’s bone marrow and your treatment has not completely removed all of your cancer or your cancer has come back (relapsed) after treatment or you are at risk of your cancer coming back
There are cells from your myeloma that can be used for making a vaccine, either at the moment or stored in frozen form. Your consultant will be able to tell you if this is the case
There is abnormal protein from the cancer cells that can be purified from your blood or that has been stored before you have had your transplant
You are at least 18 years
You are well enough to have treatment (performance status 0)
You are willing to use adequate contraception if there is a chance that you or your partner could become pregnant
Your donor is willing to be vaccinated before her/his white blood cells are collected

You cannot enter this trial if you

Have graft versus host disease
Are having drugs to suppress your immune system
Have had chemotherapy in the last 3 months
Are having any other kind of treatment for your cancer
Have any other type of cancer
Are HIV positive
Are a known carrier of hepatitis B or hepatitis C

Trial design

This is a 'pilot study'. This means that the researchers are carrying out a small study to see if it is possible to then carry out a similar study on a larger scale. This pilot study will recruit 15 patients.

You will have the standard treatment for your myeloma, whether you take part in this trial or not. This includes chemotherapy followed by a bone marrow transplant using your brother or sister’s bone marrow.

The researchers will take a sample of your cancer from when you are 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.

Your donor will have an injection of the DNA vaccine into a muscle. They will have 6 injections over a period of 3 months. They will then have their lymphocytes collected and these will be stored, in case you need them later.

If your cancer relapses, you will have an infusion or drip of your donor’s lymphocytes. The researchers hope that the lymphocytes will recognise the cancer cells and kill them, while avoiding the normal cells.

You may have more than one donor lymphocyte infusion. Your consultant will tell you how many infusions you will need. This depends on your personal circumstances and the normal practice of your hospital.

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 blood tests after your donor lymphocyte infusion. Your treatment is intensive, whether you take part in this trial or not. You will be in hospital on and off for some months.

Side effects

This is a new and experimental treatment. But the researchers are not expecting the vaccine to cause any serious side effects to your donor. Your donor may have mild swelling at their injection site, feel tired and have flu like symptoms. Muscle pains are less likely. There is information about the side effects of a bone marrow transplant on CancerHelp UK.

The researchers do not think your side effects will be made worse as a result of having a donor lymphocyte infusion following vaccination of your donor.