
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
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 BHQ880 as first line treatment for myeloma. It is for people whose kidneys are not working very well.
Doctors can use treatments such as chemotherapy and stem cell transplants to treat myeloma. And you may have drugs called bisphosphonates to help prevent bone damage. But if your kidneys are not working very well, you cannot have some of these treatments.
In this trial, doctors are looking at a drug called BHQ880. It is a monoclonal antibody which blocks a protein called DKK1. DKK1 stops cells called osteoblasts from forming new bone. This often happens if you have myeloma and causes bone damage and pain. Blocking the DKK1 protein may allow the osteoblasts to start making new bone again.
We know from laboratory research that BHQ880 may also stop myeloma cells growing, but researchers don’t know if this will happen in people.
The aims of the trial are to
You may be able to enter this trial if you
You cannot enter this trial if you
This phase 2 trial will recruit about 144 people in a number of different countries. The trial is in 2 parts.
The first part will recruit 6 to 8 people and all of them will have BHQ880.
You have treatment in 3 week periods called cycles of treatment. You have BHQ880 through a drip into a vein on the first day of each cycle. This takes about 2 hours each time. As long as you don’t have bad side effects, you can have up to 24 cycles of BHQ880.
During the first 9 cycles of treatment, you also have a drug called bortezomib and a steroid called dexamethasone. You have bortezomib as an injection into your vein on 4 days during each treatment cycle. You take dexamethasone tablets on 8 days during each cycle.
The second part of the trial will recruit about 136 people. This part is randomised. The people taking part are put into 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.
Half the people taking part have BHQ880, the other half have a dummy drug ().
You have BHQ880 (or the dummy drug) in 3 week cycles as described for the first part of the trial. You have up to 24 treatment cycles. During the first 9 cycles, everybody also has bortezomib and dexamethasone.
You will see the doctors and have some tests before you start treatment. The tests include
You may also have a bone marrow test.
You see the trial doctors every 3 weeks during treatment. People joining the first part of the trial will have some extra hospital visits in the 1st and 4th cycles of treatment to have more blood tests.
During treatment you have
You may also have another bone marrow test.
If you stop having treatment before the end of 24 cycles, you see the trial doctors a week later and have an X-ray, a CT scan, a DXA or MRI scan, blood and urine tests. If you finish all 24 cycles of treatment, you see the doctors and have these tests 4 weeks later.
The trial team will check how you are for up to 3 years after you finish treatment, but this may be by phone rather than having more hospital visits.
As BHQ880 is a new drug, there may be side effects we don’t know about yet. Possible side effects include
The side effects of bortezomib include
We have more information about the side effects of dexamethasone and bortezomib in our cancer drugs section.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Kwee Yong
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Novartis
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.