A trial looking at tabalumab for myeloma (JDCG)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Myeloma

Status:

Closed

Phase:

Phase 2/3

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.

Tabalumab is another type of biological therapy called a monoclonal antibody. It seeks out myeloma cells by looking for a particular protein.

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 nitrosoureas )
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 cancer of the cervix, breast or prostate
Have moderate to severe nerve damage (peripheral neuropathy )
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

Trial design

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.

JDCG trial diagram

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 bone marrow Open a glossary item samples. If you don’t want to give these samples, you don’t have to. You can still take part in the trial.

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.

Hospital visits

You see the doctor to have some tests before starting treatment. These tests include

A physical examination
Bone marrow test
X-rays
CT scan and MRI scan
Blood tests
Urine test
Heart trace (ECG )

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.

Side effects

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
Headache
Numbness and tingling in your hands and feet
Swelling of the arms and legs
Tiredness (fatigue)
Dizziness
Pain in the muscles or under the skin
Not having enough fluid in your body (dehydration )
Feeling bloated
Blurred vision