Biological therapy for myeloma

Biological therapies are treatments that use substances that occur naturally within the body. Or they affect the way that particular substances work in the body. Some of the drugs used stimulate the immune system or occur naturally as part of the immune system. Biological therapies used in myeloma treatment include thalidomide, bortezomib, lenalidomide and interferon.

Thalidomide is a drug that affects the chemicals cells use to signal to one another. It can affect all sorts of cell processes, including the division and growth of cancer cells. Thalidomide is also known as an anti angiogenic drug. Angiogenesis means growth of new blood vessels. Cancers need to grow their own blood vessels as they get bigger. Without its own blood supply, a cancer cannot continue to grow. So anti angiogenic drugs block the growth of new blood vessels.

We don't know exactly how thalidomide works in myeloma. There are probably quite a few different modes of action. We know it can slow the growth of myeloma cells. It may work directly on the myeloma cells, or it may encourage the immune system to attack them. 

Thalidomide is licensed in Europe to treat newly diagnosed myeloma, with the chemotherapy drug melphalan, and prednisone. In 2009 the Scottish Medicines Consortium (SMC), and in 2011 the National Institute for Health and Clinical Excellence (NICE), issued guidance saying it should be available as an option within the NHS in England for people who are newly diagnosed and are unable to have high dose chemotherapy with a stem cell transplant. 

Doctors also use it in combination with cyclophosphamide and dexamethasone to treat newly diagnosed myeloma.  It may also be used for myeloma that has

• Come back after responding to treatment (relapsed disease)
• Stopped responding to other treatments (resistant or refractory disease)

Or it may be used as a maintenance therapy, to help keep myeloma in remission after successful chemotherapy treatment.

We know quite a lot about thalidomide for relapsed or resistant disease. Thalidomide doesn't help everyone with myeloma, but it has been shown to work in about 3 to 6 out of 10 patients (30 to 60%) with relapsed or resistant disease. You might have it on its own, with steroids, or with steroids and chemotherapy. Research into thalidomide continues in order to find out the best time to use it and which dose to use.

As a maintenance therapy, studies have been done, and continue to be done. But we'll need to follow patients' progress for a long time before we really find out how well it works. There is more about thalidomide research in our section on myeloma research.

You take thalidomide as a tablet every day. Some people are very worried about taking thalidomide because of its reputation for causing birth defects. It is very dangerous in pregnancy. If you are a woman of child bearing age you must use contraception from 4 weeks before starting treatment that includes thalidomide until 4 weeks after treatment has finished. If you are a man and have a partner of child bearing age it is also important to use contraception whilst taking thalidomide and for one week after treatment has finished. 

Thalidomide does have some side effects. It can cause sleepiness, dizziness, constipation, pins and needles or numbness in fingers and toes, rashes and a drop in blood counts. It can also increase the risk of blood clots. You may need treatment with aspirin, warfarin or heparin to reduce the risk of clots.

Velcade (bortezomib) interferes with the signals that cells use to control their growth. It is a type of drug called a proteasome inhibitor. That means it stops the breakdown of proteins within cells. This leads to a build up of protein, which makes the cell die. For reasons we don't fully understand, cancer cells seem to be more easily damaged by Velcade than healthy cells.

You have Velcade as an injection into a vein. Like chemotherapy, you have Velcade in cycles of treatment, with breaks in between. You usually have treatment twice a week for 2 weeks and then have a week's break. There are some side effects, but they are often quite mild. Velcade can cause tiredness, sickness, diarrhoea or constipation, loss of appetite, pins and needles or numbness in fingers and toes, and increased risk of bruising or bleeding.

In October 2007, the National Institute for Health and Clinical Excellence (NICE) announced that it has approved a scheme for the use of Velcade on the NHS in England. This applies to people whose myeloma has come back after previous chemotherapy, and who are unable to have, or have had, a stem cell transplant. In this scheme, these patients can have up to 4 cycles of Velcade. Those people whose myeloma shows a full or partial response to the drug, will continue to have it. Those whose disease does not respond to Velcade will stop having it, and the drug manufacturers will refund the cost of the treatment to the NHS. NICE define a partial response as at least a 50% reduction in the levels of abnormal myeloma protein in the blood.

In Scotland in November 2009, the Scottish Medicines Consortium (SMC) announced that it has approved Velcade on the NHS for people whose myeloma has come back after one previous chemotherapy and who are unable to have, or have had, a stem cell transplant.

And in 2011 NICE said Velcade should be available as a first treatment within the NHS in England, for people unable to have high dose chemotherapy with a stem cell transplant or thalidomide. They recommend that people have it with chemotherapy and a steroid.

Lenalidomide (Revlimid) works in a similar way to thalidomide. It blocks cancer cells from developing new blood vessels. Lenalidomide is licensed in the UK to treat people with myeloma who have had previous treatment. In combination with the steroid dexamethasone it can slow the growth of myeloma.

Because it is similar to thalidomide, lenalidomide may cause birth defects if it is taken during pregnancy.  But it's side effects are different from thalidomide. They include lowered production of blood cells by the bone marrow, tiredness and weakness, constipation or diarrhoea, nausea, blood clots, and skin rashes.

Lenalidomide comes as capsules that you swallow. You usually take lenalidomide capsules daily for 3 weeks and then have a week with no treatment. This cycle is repeated for as long as the treatment controls the myeloma or until side effects become too great. You should take the capsules at the same time each day. Dexamethasome is taken during the treatment.

In June 2009, the National Institute for Health and Clinical Excellence (NICE), issued guidance that lenalidomide should be available on the NHS in England. This guidance was widely reported in the news at the time. NICE says that lenalidomide, with dexamethasone, should be available to people with myeloma who have already had at least 2 different treatments. If people continue to have treatment with lenalidomide after 2 years, the company that makes the drug will pay for it.

In May 2010, the Scottish Medicines Consortium (SMC) issued guidance saying that lenalidomide can be used in combination with dexamethasone for people who have already had one or more treatments.

Interferon is a biological therapy. It may sometimes be given as maintenance therapy for myeloma, but thalidomide is used more often now. 

You are most likely to have interferon as an injection under the skin 2 or 3 times a week. The most common side effects are flu like symptoms after your injection. You may have a temperature, headache or general muscle aches and pains. These side effects can be mild. If they are causing problems for you, you may find that paracetamol helps. You could also try having your injection last thing at night, so that you sleep through some of the side effects.

There is more information about biological therapies in this section of CancerHelp UK and in the myeloma research page.