A trial looking at having a radiolabelled monoclonal antibody before an autologous stem cell transplant for myeloma

Who can enter

You can enter this trial if you

• Have myeloma
• Are in partial remission after chemotherapy and due to start intensive treatment before having an autologous stem cell transplant
• Have had enough stem cells collected for your doctors to be able to give you 2 transplants (if needed)
• Are well enough to take part
• Have satisfactory blood test results
• Are prepared to use a reliable form of 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

• There is no sign of your myeloma after earlier chemotherapy (so you are in complete remission)
• There are a lot of myeloma cells in your bone marrow (your doctor can advise you on this)
• You have already had intensive treatment and an autologous stem cell transplant
• You have had chemotherapy for myeloma in the last 4 weeks (you can take part if you had cyclophosphamide chemotherapy to help collect your stem cells)
• You have had radiotherapy (except for pain control) or biological therapy in the last 4 weeks
• You have had major surgery in the last 4 weeks and haven’t recovered yet
• You still have bad side effects from other treatment (apart from hair loss)
• You have an antibody known as HAMA (the doctors will test for this)
• You have had allergic reactions in the past
• You have had eczema or asthma in the past
• You have heart failure or other heart problems that are a cause for concern
• You have another serious medical condition or an infection that cannot be controlled with medicine
• You are known to be HIV, Hepatitis B or Hepatitis C positive
• You are pregnant or breastfeeding

Trial design

This is a randomised trial. It will recruit about 90 people. Everybody taking part will be put into one of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

People in group A will have a radiolabelled monoclonal antibody called BW 250/183 before they have high dose melphalan chemotherapy and a stem cell transplant.

People in group B, will not have the monoclonal antibody, but will have high dose melphalan and a stem cell transplant. This is known as the standard treatment.

If you are in group A, there are 2 phases to the trial. In the first phase, the researchers will look at where the monoclonal antibody goes in your body. You have a drip into a vein (an infusion) that contains the antibody with a very small amount of radioactive material attached. This takes about 15 minutes. Then the trial team will take some blood samples and you have a scan using a gamma camera. The scan shows up areas of radioactivity so should pick up where the antibody has gone. The scan takes 40 to 60 minutes.

You have more pictures taken with the gamma camera on the 2nd, 4th and 5th days after the infusion. Each time you have a scan, you have another blood test. You have a bone marrow test on the 2nd day to see how much of the antibody is in your bone marrow.

If the tests show that there is more radioactivity in your bone marrow and spleen than anywhere else in your body, you will move on to the 2nd phase.

In the 2nd phase of the trial, you have another infusion of the radiolabelled antibody, but this time it carries a much higher dose of radioactive material to kill the myeloma cells. 12 days later, you will have high dose melphalan chemotherapy and then your stem cell transplant 2 days later.

Hospital visits

You will see the doctors and have some tests before you can take part in this trial. The tests include

• Physical examination
• Bone scan
• Bone marrow test
• Blood tests
• Urine tests
• Chest X-ray
• Heart trace (ECG)

If you are in group A, you will have at least 6 extra hospital visits before your stem cell transplant. You will be at the hospital for about 2 hours each time.

Having the monoclonal antibody, will not affect how long you are in hospital when you have your transplant. The length of time people have to stay in hospital depends on how quickly their blood counts recover.

When you go home after your transplant, you will have to go back to hospital for regular check ups and blood tests. You will have a bone marrow test and a bone scan after about 3 months. You will have follow up appointments with the trial team for at least a year.

Side effects

There is more information about side effects of melphalan and having a stem cell transplant on CancerHelp.

It is possible that having the radiolabelled monoclonal antibody may make some side effects worse. These include sore mouth, diarrhoea and damage to the liver.

Some people have an allergic reaction to the monoclonal antibody. You will have antihistamine drugs and paracetamol before the treatment to reduce the risk of this. And the research team will keep a close eye on you during the treatment.

Because of the radioactivity, for 7 days after having the radiolabelled MAB you should avoid contact with babies, young children and women who could be pregnant.