A trial to see if other drugs affect the way bortezomib works in people with non Hodgkin's lymphoma and myeloma

Please note this trial is no longer recruiting patients.

This trial is looking at whether other drugs affect the way the body breaks down bortezomib (Velcade) in people with non Hodgkin’s lymphoma or myeloma that has continued to grow.

Bortezomib is a type of biological therapy called a proteasome inhibitor. Doctors use it to treat myeloma that has come back after treatment. Clinical trials are currently looking at using bortezomib for people with non Hodgkin’s lymphoma.

This trial is looking at the effect of two drugs on bortezomib. The first is rifampicin. Rifampicin is not used to treat cancer. It is an antibiotic used to treat or prevent infections. The second is a steroid called dexamethasone. These two drugs activate an enzyme in the body called CYP3A4.

The CYP3A4 enzyme breaks down bortezomib. Doctors think that rifampicin and dexamethasone will lower the amount of bortezomib because they increase the amount of the CYP3A4 enzyme. This may affect the way that bortezomib works. But researchers are not sure yet.

The results of this study may help doctors to improve treatment for people with myeloma and non Hodgkin’s lymphoma in the future.

Recruitment

Start 31/07/2007

End 18/12/2009

Phase

Phase 1

Who can enter

You can enter this trial if you

Have non Hodgkin’s lymphoma or myeloma that has come back or stopped responding to treatment
Have satisfactory blood results
Are willing to give up caffeine and chocolate on certain days in the second and third treatment cycle and avoid grapefruit juice, Seville oranges, alcohol, quinine and nicotine during treatment - your trial doctor can tell you more about this
Are well enough for treatment (Karnofsky performance status of 50 or more)
Are at least 18 years old
Are willing to use reliable contraception if there is any chance that you or your partner could become pregnant

You cannot enter this trial if you

Have had bortezomib (Velcade) before
Have had any medication that affects the CYP3A4 enzyme in the last 4 weeks - you can check this with your doctor
Have moderate or severe damage to the nerves in your hands or feet from chemotherapy (peripheral neuropathy)
Are still having side effects from cancer treatment
Have had major surgery in the last 2 weeks
Have had rifampicin or steroids in the last 4 weeks
Have had any treatment as part of a clinical trial in the last 4 weeks
Have had any other cancer unless it was successfully treated more than a year ago
Are allergic to rifampicin, any other antibiotics, steroids, boron or mannitol - you can check this with your doctor
Have any other serious medical condition that means you cannot take part in this study
Are pregnant or breastfeeding

Trial design

This is a phase 1 study and will recruit 45 people.

The study will recruit people in 2 stages. In the first stage, there are 2 different treatment groups.

Patients in group 1 have bortezomib as an injection into a vein twice a week for 2 weeks. And then no treatment in the third week. Each 3 week period is one cycle of treatment. You have up to 3 cycles of treatment.

Patients in group 2 have bortezomib as described above and rifampicin. You take rifampicin as a tablet for 7 days during your 3rd cycle of treatment.

Please note - The first stage of the trial is now complete. If you join stage 2, you will have bortezomib as described above, but with dexamethasone. You have dexamethasone as a tablet for 4 days in the first and second week of the 3rd treatment cycle.

At the end of each cycle, you will have some tests to see how well bortezomib is working. If the treatment is not helping you, the trial doctor will probably decide to stop treatment. They will then discuss other treatment options with you. If the treatment is working after 3 cycles, you will continue to have bortezomib alone for as long as it is working.

You will fill in a questionnaire before you start treatment and at the beginning of each treatment cycle. The questionnaire will ask about any side effects you have and how you have been feeling. This is called a quality of life questionnaire.

The trial team will ask your permission to take an extra blood sample. This is so that they an look at the DNA in your blood. If you don't want to give this sample for research, you don't have to, you can still take part in the trial.

Hospital visits

Before you can take part in this study, a doctor will examine you and you will have some tests. The tests include

Blood tests
Urine tests
ECG (heart trace)

You will have your treatment in the hospital outpatient department. And you will see the trial doctor at each hospital visit. You will have some blood and urine tests at the end of each cycle to see how well treatment is working.

You will have extra blood samples taken in the 2nd and 3rd treatment cycles. But the trial doctor can tell you more about this.

A month after you finish treatment, the trial doctor or nurse will contact you at home to find out how you are feeling. And you will continue to see your own doctor for check ups and to discuss other treatment options.