A study looking at bortezomib for Waldenstrom's macroglobulinaemia (UK R2W)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is looking at adding bortezomib (Velcade) to cyclophosphamide and rituximab (Mabthera) for Waldenstrom’s macroglobulinaemia (pronounced wall-den-stroms mak-row-glob-you-lin-ee-mee-a). This is a rare and slow growing type of non Hodgkin lymphoma (NHL). It is also sometimes called lymphoplasmacytic NHL (pronounced lim-fo-plaz-ma-sit-ik). This study is supported by Cancer Research UK.
Doctors can treat Waldenstrom’s macroglobulinaemia with a combination of drugs called fludarabine, cyclophosphamide and rituximab (FCR). This combination can work, but doctors are always looking to improve treatment.
Bortezomib is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
We know from research that bortezomib helps people whose Waldenstrom’s macroglobulinaemia has come after treatment or continued to grow during treatment. We also know that having bortezomib with rituximab may be better.
In this trial the researchers want to combine bortezomib with cyclophosphamide and rituximab (BCR) to see if it can help people with Waldenstrom’s macroglobulinaemia. They also want to compare BCR with FCR.
The aims of this trial are to find out
- How well BCR works for people with Waldenstrom’s macroglobulinaemia
- How safe BCR is
- What the side effects are
- If BCR should be studied further
Who can enter
You may be able to enter this trial if you
- Have Waldenstrom’s macroglobulinaemia that your doctor feels needs to be treated
- Have a protein, called IgM, in your blood and it can be measured - your doctor can confirm this
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are willing to use reliable contraception during treatment and for at least a year afterwards if there is a chance you or our partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if
- You have already had treatment for your Waldenstrom’s macroglobulinaemia
- You have low levels of blood cells and that is caused by a disease where the body mistakes something that is natural to it as foreign (an
autoimmune disease 
) - You have moderate to severe nerve damage
- Your kidneys aren’t working
- You have severe liver damage
- You have hepatitis B or hepatitis C and your infection is causing problems
- You are HIV positive
- You are allergic to the chemical element boron or the drug mannitol
- You have had another cancer in the past 5 years apart from successfully treated non melanoma skin cancer or a very early stage cancer that was successfully treated (
in situ carcinoma ) - You have an infection that needs treatment
- You have a very serious problem with your heart, lungs, nerves or any other serious medical condition
- You are having treatment as part of another clinical trial
- You are pregnant or breastfeeding
Trial design
This is a phase 2 trial. There are 2 stages in this trial.
In the first stage it will recruit 6 people. Everyone will have bortezomib, cyclophosphamide and rituximab. The researchers want to find out what the side effects of this combination are and how safe it is. If the side effects aren’t too bad and the researchers feel it is safe to give they will go on to the 2nd stage.
The second stage is a randomised trial. It will recruit 50 people.
You will be put into 1 of 2 treatment groups by a computer. Neither you nor your doctor can choose which group you are in.
The 2 groups are
- Bortezomib, cyclophosphamide and rituximab (BCR)
- Fludarabine, cyclophosphamide and rituximab (FCR)
The treatment is organised into 4 week periods, which are called cycles of treatment. When you get to the end of the first cycle, you start the second and so on. You can have up to 6 cycles.
You have rituximab as an injection into a vein. You have rituximab once every week during the 2nd and 5th cycle of treatment only.
You have bortezomib as an injection under the skin. You have it once a week for the first 3 weeks of each cycle of treatment.
Fludarabine and cyclophosphamide are tablets. If you are in the BCR group, you take the cyclophosphamide tablets once a week during the first 3 weeks of each cycle. If you are in the FCR group you take the cyclophosphamide and fludarabine tablets during the first 3 days of each cycle of treatment.
After 3 cycles of treatment (12 weeks) you have tests to see how you are responding to treatment. Depending on the results of the tests and if the side effects aren’t too bad you can have another 3 cycles of treatment.
The research team will ask you to fill in a questionnaire before starting treatment, at 3 months and after finishing treatment. It will ask you about how you have been feeling and any side effects you may have. This is called a quality of life study.
Hospital visits
You see the doctor to have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- Heart trace (
ECG ) - CT scan
- Bone marrow test
During treatment you see the doctor regularly for a physical examination, blood tests and to check for side effects.
At the end of treatment you see the doctor for blood tests and a CT scan if needed. After another 3 months, you see the doctor for blood tests and a bone marrow test. You then see the doctor every 3 months for 5 years.
Side effects
The most common side effects of fludarabine, cyclophosphamide and rituximab (FCR) are
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Feeling or being sick (nausea)
- Tiredness (fatigue)
- Feeling weak
- Constipation or diarrhoea
- Flu like symptoms
The most common side effects of bortezomib are
- A drop in blood cells
- Rash, dry and itchy skin
- Pain in hands or feet
- Muscle pain
- Bone pain
- Flu like symptoms
- Shortness of breath
- Feeling or being sick
- Loss of appetite
- Constipation or diarrhoea
- Tiredness
- Headache
Your doctor will talk to you about the possible side effects of treatment before you agree to take part in the trial.
We have more information about bortezomib, cyclophosphamide, fludarabine and rituximab in our cancer drugs section.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr Rebecca Auer
Supported by
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Janssen-Cilag
NIHR Clinical Research Network: Cancer
Roche
University College London (UCL)
Other information
This is Cancer Research UK trial number CRUK/11/030.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
