"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A study looking at using bortezomib for myeloma after stem cell transplant (BCT)
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Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at bortezomib for people with myeloma after they have had a transplant of their own stem cells (
Doctors can treat myeloma with
Bortezomib is an anti cancer drug. We know from research that bortezomib can work well as a treatment for people with cancer.
The researchers think that people may have a better response to their stem cell transplant if they have bortezomib after it. If so, this may increase the amount of time they stay free of myeloma.
The aims of this trial are to find out
- How safe and acceptable it is to give bortezomib after a stem cell transplant
- If bortezomib can increase the amount of time people are free of myeloma
- How bortezomib affects quality of life
- If bortezomib can improve bone health
Who can enter
You can enter this trial if
- You have had high dose melphalan and stem cell transplant using your own stem cells in the last 3 or 4 months
- Your myeloma has not continued to grow, or started to grow again, after your transplant
- You have satisfactory blood test results
- You are able to look after yourself and are up and about for at least half the day (performance status 0, 1, 2)
- You are willing to use reliable contraception while having treatment as a part of the study and for 6 months afterwards if there is a chance you or your partner could become pregnant
- You are 18 to 70 years old
You cannot enter this trial if you
- Have myeloma that continued to get worse during or soon after treatment with high dose melphalan
- Have already had bortezomib
- Had bisphosphonate drugs after your transplant
- Have had problems with your nerves such as
spinal cord compression, or nerve pain that interferes with your normal daily activities
- Have severe liver problems
- Have or have had severe heart problems
- Have low blood pressure
- Have had serious breathing problems
- Are allergic to bortezomib, boron or mannitol – you can check this with your doctor
- Have had medication, or used a medical device, as part of clinical trial in the last 4 weeks
- Have another serious medical condition that could affect you taking part in this trial
This is a phase 2 study. It will recruit about 45 people.
Everyone will have bortezomib. You start bortezomib about 3 months after your stem cell transplant. You have it once a week for 4 weeks as an injection under the skin. Each 4 week period is called a cycle of treatment.
After 3 cycles of treatment, you have an assessment to see how your myeloma is responding. If the treatment is helping you and there aren’t any bad side effects you can have up to another 5 cycles, making a maximum total of 8 cycles.
If your myeloma has continued to grow you have no more treatment as part of this study. Your doctor will talk to you about what other treatments may be available to you.
Before you take part in the trial, and at times during it, you will have blood tests taken to measure the levels of myeloma proteins in your blood. Before you start treatment, then at 6 and 12 moths after your transplant, you will be asked to collect your urine for 24 hours. This is so the team can test for myeloma proteins in your urine. The hospital will provide all the information and equipment you need to do the 24 hour urine collection at home.
You fill in a questionnaire before you start treatment, during treatment and 4 weeks after finishing treatment. This will ask how you have been feeling and about any symptoms you have had. This is called a quality of life questionnaire.
You will see the doctor to have some tests before starting treatment. These include
- A physical examination
- Blood tests
- Bone marrow test
- X-ray - if needed
- CT scan, MRI scan or PET scan – if needed
You will have blood tests done every 4 weeks before each cycle of treatment.
At 6 months and 1 year after treatment you will have
- Blood tests
- Bone marrow test
- X-ray – if needed
- CT scan, MRI scan or PET scan - if needed
The side effects of bortezomib can include
- A drop in blood cells causing an increased risk of bleeding, bruising and infection
- Feeling weak
- A rash or itchy skin
- Feeling, or being, sick
- Weight loss
- Pain or numbness and tingling in the hands or feet
- Flu like symptoms
- Changes in blood pressure
- Dizziness and fainting
- Sore muscles and joints
- Shortness of breath
- Changes to taste
How to join a clinical trial
Professor Kwee Young
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)