A trial looking at carfilzomib for myeloma (MUK 5)

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

This trial is looking at combining a drug called carfilzomib with cyclophosphamide chemotherapy and dexamethasone to treat myeloma. This trial is for people whose myeloma continued to grow during treatment or came back after treatment.

More about this trial

Doctors can treat myeloma that has come back, or continued to grow despite treatment, with a combination of a biological therapy drug, chemotherapy drug and a steroid

A combination they use is bortezomib (Velcade), cyclophosphamide and dexamethasone. This combination can help people with myeloma. But doctors are always looking for ways to improve treatment.

 

Carfilzomib is another type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

The researchers want to compare the combination of carfilzomib, cyclophosphamide and dexamethasone (CCD) with the combination of bortezomib, cyclophosphamide and dexamethasone (CVD) to find out which is the best combination to treat myeloma that has come back, or continued to grow despite treatment.

The researchers also want to find out if continuing with carfilzomib after the initial treatment can stop or delay myeloma coming back. People who had carfilzomib may then be able to continue having it after their initial treatment.

Who can enter

You may be able to enter this trial if

  • You have myeloma that has come back after treatment or continued to grow despite treatment and is causing symptoms
  • Your myeloma can be measured with a blood 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 the trial and for 30 days afterwards if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

You cannot enter this trial if you

  • Have myeloma that doesn’t show up in a blood or urine test (non secretory myeloma)
  • Have a collection of white blood cells called plasma cells (a plasmacytoma) growing outside your bones and you have no other symptoms of myeloma
  • Have already had treatment for myeloma that has come back or continued to grow despite treatment – if you had radiotherapy to control pain you may be able to take part or if you had bortezomib and your myelaoma had at least a partial response and had not got worse within 6 months of your last dose of bortezomib you may be able to take part
  • Have already had carfilzomib
  • Have had major surgery in the past 3 weeks
  • Have had treatment for an infection in the past 2 weeks
  • Have had chest pain (angina) or a heart attack in the past 4 months or any other serious heart problem
  • Have high blood pressure or diabetes that isn’t controlled with medication
  • Have moderate to severe nerve damage
  • Have an inflammation of the bladder that causes bleeding (haemorrhagic cystitis)
  • Have fluid on the lungs (pleural effusion) or fluid in the abdomen (ascites) that has needed draining in the past 2 weeks
  • Have a certain type of lung disease that needs treatment
  • Are HIV, hepatitis B or hepatitis C positive
  • Have had another cancer in the past 3 years apart from successfully treated non melanoma skin cancer or thyroid cancer, carcinoma in situ of the cervix or in situ breast cancer, prostate cancer with a Gleason score of 6 or less and a stable PSA blood test result or any other cancer that has been successfully removed with surgery or that your doctor thinks will not affect you taking part in this trial
  • Are known to be allergic to the drugs that are used in this trial or any of their ingredients
  • Are pregnant or breastfeeding

Trial design

This is a phase 2 trial. It will recruit up to 300 people. It is a randomised trial. The people taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

The 2 groups are

  • Carfilzomib, cyclophosphamide and dexamethasone (CCD)
  • Bortezomib, cyclophosphamide and dexamethasone (CVD)

MUK 5 trial diagram (a)

If you are in the CCD group, you have carfilzomib as an injection into a vein. You have it twice a week for 3 weeks then a week of not having it. Cyclophosphamide is a tablet. You have it weekly for 3 weeks then a week of not having it. Dexamethasone is a tablet. You have it weekly. Each 4 week period is called a cycle of treatment. If the treatment is helping you and the side effects aren’t too bad, you can have up to 6 cycles of CCD.

If you are in the CVD group, you have bortezomib as an injection under the skin. You have it twice a week for 2 weeks then have a week of not having it. You have the cyclophosphamide and dexamethasone tablets once every week. Each 3 week period is a cycle of treatment. You can have up to 8 cycles of CVD.

After their initial treatment, those who had CCD may be able to continue having carfilzomib if their myeloma didn’t get any worse. You will be randomised into 1of 2 groups, those who

  • Continue to have carfilzomib
  • Don’t have carfilzomib but will be monitored

MUK 5 trial diagram (b)

In this part of the trial you have carfilzomib twice a week on weeks 1 and 3 of every 4 week period. Each 4 week period is a cycle of treatment. You have this for 6 cycles. Then you have carfilzomib twice a week in the 1st week of treatment and 3 weeks of no carfilzomib. You have this for 12 cycles.

If you agree to take part in this trial, the researchers will ask for a blood sample before you start treatment and a sample of tissue when you have your bone marrow test. You must agree to have these samples taken if you take part in this trial.

Hospital visits

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

During treatment you see the doctor regularly for a physical examination and blood tests.

After treatment you see the doctor every month until your myeloma starts to grow again.

Side effects

The most common side effects of carfilzomib are

The most common side effects of cyclophosphamide are

  • A drop in blood cells
  • Tiredness
  • Shortness of breath
  • Feeling or being sick
  • Loss of appetite
  • Hair loss

The most common side effects of bortezomib are

Side effects of dexamethasone include

  • Mood changes
  • Difficulty sleeping
  • High blood pressure
  • An increase in the levels of sugar in your blood

Your doctor will talk to you about the possible side effects of treatment before you agree to take part in this trial.

We have more information about cyclophosphamide, bortezomib and dexamethasone in our cancer drugs section.

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 Kwee Yong

Supported by

Experimental Cancer Medicine Centre (ECMC)
Institute of Cancer Research (ICR)
NIHR Clinical Research Network: Cancer
Myeloma UK
Onyx Pharma
Leeds Institute of Clinical Trials Research (University of Leeds)
Haematological Malignancies Diagnostic Service (HMDS)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10913

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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