
"I am glad that taking part in a trial might help others on their own cancer journey.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new combination of drugs before a stem cell transplant and long term treatment for high risk myeloma and plasma cell leukaemia.
Myeloma is a type of blood cancer that starts in the bone marrow. Plasma cell leukaemia is a very rare type of blood cancer. It is similar to myeloma as it affects the plasma cells (PCL) in the blood and bone marrow. PCL and high risk myeloma are treated in the same way. So, when we refer to myeloma in the summary, we mean both.
There are different types of myeloma. Doctors look at blood and bone marrow samples to work out which type you have. This trial is looking at treatment for a type called high risk myeloma. It is linked with having certain gene changes (mutations) and can be more difficult to treat.
One of the usual treatments for myeloma is a stem cell transplant using your own cells. Before and after the transplant you usually have a combination of drugs that include chemotherapy and targeted drugs such a lenalidomide or bortezomib.
This trial is looking at a new combination of 5 drugs to treat newly diagnosed myeloma. Doctors already use these drugs in various combinations to treat myeloma. But this is the first time people with high risk myeloma are having all 5 together.
The drugs they are looking at are:
The main aims of the trial are to:
You may be able to join this trial if all of the following apply.
You:
Who can’t take part
You cannot join this trial if any of these apply.
Myeloma related
You:
Medical conditions
You:
Other
You:
This a phase 2 trial. The trial team need 95 people to take part.
This trial involves:
You have:
The schedule of drugs is different for each part of the trial. The trial team will tell you exactly when you have each drug and for how long.
You have treatment for about 3 years as long it is working and you can cope with the side effects. You might have treatment for longer if you have maintenance treatment. When you stop treatment, your doctor will talk to you about other treatment options.
Induction treatment
You have treatment in cycles. Each 3 week period is a cycle of treatment. In this part of the trial, you have treatment in week 1 and 2 and no treatment in week 3.
You have:
You have up to 6 cycles. This takes about 6 months.
Stem cell transplant
You have your stem cells collected at the hospital. You have this in the outpatient department. The trial team will tell you more about this. You are then admitted to hospital to have high dose chemotherapy with a chemotherapy drug called melphalan. This is to kill all the myeloma cells. The following day you have a stem cell transplant with the cells they collected. You have this as a drip into a vein.
Consolidation (part 1)
You have treatment in cycles. Each 4 week period is a cycle of treatment. In this part of the trial you have:
You have up to 6 cycles.
Consolidation (part 2)
You have treatment in cycles. Each 4 week period is a cycle of treatment. In this part of the trial you have:
You have up to 12 cycles.
Maintenance treatment
You have treatment in cycles. Each 4 week period is a cycle of treatment. You have:
You continue treatment until your myeloma gets worse.
Quality of life
The researchers will ask you to fill out a questionnaire before starting treatment, at set times during the trial and after finishing treatment. The questionnaire will ask about any side effects you have had and how you are feeling. We call this a quality of life study.
Research samples
The researchers will ask for a sample of your bone marrow that your doctor will take when you have a bone marrow test. You have 2 extra bone marrow samples if you take part in this trial compared to having standard treatment.
The researchers will also ask to take extra blood tests as part of this study. Where possible you have these at the same time as your routine blood tests.
The researchers will use the samples to find out how well treatment is working. They also look at genes to find out more about myeloma.
They will ask to store any leftover samples for future research. You don’t have to agree to this if you don’t want to. You can still take part in the trial.
MRI scan sub study
The trial team might ask you to have 3 extra MRI scans. This is to look at another way to monitor the myeloma. But you don't have to agree to this if you don't want to. You can still take part in the main trial.
You see a doctor and have some tests before you start treatment. These include:
You have the above tests again during and after your treatment.
You have bortezomib, daratumumab and cyclophosphamide at the hospital in the outpatient department. Lenalidomide and dexamethasone are tablets and you take these at home. Although on certain days the trial team might ask you to take them at the hospital when you have your other treatment.
You will be in hospital for about 4 to 6 weeks to have your stem cell transplant. You will be at a high risk of infection, so you will be in a private room.
When you stop treatment, you see the trial team 3 months later for a check up. You see your doctor after that at routine hospital appointments. The trial team will check your medical notes to see how you are getting on.
Having this combination of treatment is new so there may be side effects we don’t know about yet. The trial team will monitor you during the time you have treatment and you’ll have a phone number to call them if you are worried about anything
Some of the most common side effects of bortezomib include:
Some of the most common side effects of lenalidomide include:
Some of the most common side effects of daratumumab include:
The trial doctors will explain all the possible side effects before you join the trial.
We have information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Martin Kaiser
Myeloma UK
Celgene
Janssen
University of Leeds
Freephone 0808 800 4040
"I am glad that taking part in a trial might help others on their own cancer journey.”