A trial of bortezomib and thalidomide in people with myeloma whose kidneys are not working well (OPTIMAL)

Cancer type:

Myeloma

Status:

Open

Phase:

Phase 2

This trial is comparing 2 drugs called bortezomib and thalidomide for newly diagnosed myeloma. It is for people who have myeloma and whose kidneys are not working well.

Some people with myeloma have damage to their kidneys Open a glossary item. This is because myeloma often causes high levels of proteins called free light chains in the blood. These extra proteins can damage the kidneys, as they pass through from the blood into the urine.

In this trial, doctors are looking at 2 drugs called bortezomib and thalidomide. Earlier research has shown that both drugs can lower the number of free light chains in the blood. But the doctors aren’t sure which works better so they want to find out more.

Bortezomib and thalidomide are both types of biological therapies Open a glossary item. They are cancer growth blockers. They stop the signals that cancer cells use to divide and grow.

Everyone taking part will also have a standard chemotherapy drug called bendamustine and a steroid drug called dexamethasone.

The aims of the trial are to

  • Compare bortezomib with thalidomide to see which works better to reduce the number of free light chains in the blood
  • Find out if lowering the number of free light chains earlier on improves the chances of the kidneys recovering
  • Learn more about the side effects and how these drugs affect quality of life

Who can enter

You may be able to join this trial if all of the following apply. You

  • Have recently been diagnosed with myeloma
  • Have severe kidney damage caused by myeloma (your doctor can tell you more about this)
  • Have satisfactory blood test results
  • Are willing to use reliable contraception during the trial if there is any chance that you or your partner could become pregnant
  • Are at least 18 years old

You cannot join this trial if any of these apply. You

  • Have had myeloma treatment in the last 2 weeks (apart from dexamethasone)
  • Have kidney failure that is not related to your myeloma
  • Are going to have another treatment to reduce the free light chains in the blood such as plasma exchange or ‘high cut off dialysis’ (your doctor can tell you more about this)
  • Have had an experimental drug as part of another clinical trial in the last 3 months
  • Have had another cancer in the last 2 years apart from carcinoma in situ Open a glossary item of the cervix or breast, non melanoma skin cancer Open a glossary item or early stage prostate cancer that was successfully treated
  • Have moderate to severe nerve damage (neuropathy)
  • Are known to be allergic to any of the trial drugs
  • Have any other serious medical condition that the trial team think could affect you taking part
  • Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The researchers need 120 people to join. It is a randomised trial. You are put into 1 of 2 groups by a computer. Neither you nor doctor can choose which group you are in.

You have treatment in 3 week periods called cycles of treatment. You have between 4 and 6 cycles.

You have bendamustine as a drip into a vein twice during each cycle. You take dexamethasone tablets for 2 days on 4 occasions in each treatment cycle.

Thalidomide is a tablet that you take every day.

You have bortezomib as either injections under the skin or as a drip into a vein. You have it 4 times in each treatment cycle.

You may also need to have treatment to remove the free light chain proteins from the blood with a machine to help your kidneys to work (dialysis). If this is necessary, your doctor can tell you more about it.

The trial team will ask you to fill out a questionnaire before you start treatment and when you stop treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the doctor to have some tests before taking part in this trial. These tests include

You go to hospital to have bendamustine and bortezomib. During treatment everyone will see the doctor every 3 weeks for a check up and blood tests. When you finish treatment, you see the trial doctor 1 month later and a year after that. But in between you will see the doctor for your routine myeloma appointments.

Side effects

The most common side effects of bortezomib include

The most common side effects of thalidomide include

  • Constipation
  • Muscle weakness
  • Tingling or numbness in your hands or feet
  • Dizziness
  • Skin rash
  • Mood changes
  • Feeling sick
  • Headaches

We have more information about

Location

Basingstoke
Canterbury
Epsom
Liverpool
Oxford
Portsmouth

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr. Karthik Ramasamy

Supported by

Bloodwise
Janssen-Cilag
NIHR Clinical Research Network: Cancer
Oxford University Hospitals NHS Trust
Warwick Clinical Trials Unit 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12218

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

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