Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at tabalumab for myeloma (JDCG)
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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 drug called tabalumab alongside bortezomib and dexamethasone for myeloma that has come back after treatment.
Doctors often treat myeloma with chemotherapy and biological therapies. If myeloma comes back, doctors may treat it with a biological therapy drug called bortezomib. They may also use a drug called dexamethasone.
The researchers think that combining tabalumab with bortezomib and dexamethasone may be better than bortezomib and dexamethasone alone for people whose myeloma has come back.
The aims of this trial are to find out
- How much tabalumab to give
- How well tabalumab combined with bortezomib and dexamethasone works
- What the side effects are
Who can enter
You may be able to enter this trial if
- You have had at least 1 but no more than 3 other types of treatment, your myeloma is getting worse or causing symptoms and you need to have more treatment
- Your myeloma can be measured using a blood test or urine test
- Your other blood test results are satisfactory
- You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- You are willing to use reliable contraception during treatment and for 3 months afterwards if you or your partner could become pregnant
- You are at least 18 years old
You cannot enter this trial if you
- Didn’t respond very well to earlier treatment, or your myeloma started to come back within 2 months of having bortezomib or a similar drug
- Have had any cancer treatment in the past 3 weeks (6 weeks if you had mitomycin C or drugs called
- Have had an experimental drug as part of a clinical trial in the past 3 weeks
- Are planned to have a transplant of your own bone marrow or stem cells (
autologous transplant) as part of your treatment to stop myeloma coming back (consolidation treatment)
- Have had a
transplant using donor stem cells (allogeneic transplant)
- Have a type of non Hodgkin lymphoma called Waldenstrom’s macroglobulinemia
- Have had any other cancer in the last 3 years, apart from successfully treated non melanoma skin cancer, or
in situ cancerof the cervix, breast or prostate
- Have moderate to severe nerve damage (
- Have had treatment with a drug called a BAFF inhibitor before – your doctor can advise about this
- Have had tabalumab before
- Have a heart problem
- Have an infection
- Are HIV, hepatitis B or hepatitis C positive – the researchers will test for these when you agree to take part in the trial
- Have any other medical condition that could affect you taking part in this study
- Are allergic to tabalumab similar drugs, or their ingredients
- Are pregnant or breastfeeding
This is a phase 2/3 trial. There are 2 stages to this trial. The first stage will recruit 213 people. The second stage will recruit 558 people.
It is a randomised trial. The people joining the first part of the trial are put into 1 of 3 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in either. This is called a double blind trial.
People in group1 have bortezomib, dexamethasone and a dummy drug (placebo).
People in group 2 have bortezomib, dexamethasone and tabalumab.
People in group 3 have bortezomib, dexamethasone and a higher dose of tabalumab.
In the second part of this trial, the researchers will only be testing 1 dose of tabalumab, so there are just 2 treatment groups.
You have tabalumab (or the dummy drug) as an injection into a vein. It takes 30 minutes. You have it once every 3 weeks. You can have bortezomib as an injection under the skin or as an injection into the vein. You have it twice a week for 2 weeks then have a break for 10 days. Dexamethasone is a tablet you have them for 2 weeks and then have a break for a week. Each 3 week period is called a cycle of treatment. You can have up to 8 cycles of treatment.
The trial team will ask you to fill out a questionnaire before you start treatment, during treatment and then after your treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
If you agree to take part in this study, the researchers will ask for blood, urine and
They will also ask for a blood sample to look at your genes to understand more about how the drugs you take affect you. You must agree to this to take part in this trial.
You see the doctor to have some tests before starting treatment. These tests include
- A physical examination
- Bone marrow test
- CT scan and MRI scan
- Blood tests
- Urine test
- Heart trace (
During treatment you see the doctor regularly and have the same tests listed above, apart from the X-rays, CT scan and MRI scan.
After treatment you see your doctor regularly.
Tabalumab is a new drug and there may be side effects we don’t know about. The most common known side effects of taking tabalumab and bortezomib together include
- Shortness of breath
- Diarrhoea or constipation
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Loss of appetite and taste changes
- Feeling or being sick (nausea)
- Trouble sleeping
Numbness and tingling in your hands and feet
- Swelling of the arms and legs
- Tiredness (fatigue)
- Pain in the muscles or under the skin
- Not having enough fluid in your body (
- Feeling bloated
- Blurred vision
Bortezomib can also cause fever and shivering.
How to join a clinical trial
Dr Majid Kazmi
Eli Lilly and Company Limited
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer