A study of carfilzomib and daratumumab for myeloma (CANDOR)

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

Cancer type:

Blood cancers
Myeloma

Status:

Closed

Phase:

Phase 3

This study is for people whose myeloma has come back or whose treatment has stopped working.

More about this trial

The usual treatment for myeloma is chemotherapy and a steroid drug Open a glossary item. You might have these 2 drugs on their own or alongside a targeted drug such as thalidomide or bortezomib.

But if the myeloma comes back or doesn’t go away afterwards, it can be more difficult to treat. So researchers are looking at ways to improve treatment.

In this study, they are looking at 2 drugs called carfilzomib and daratumumab. They are both targeted cancer drugs.

These 2 drugs stop signals that cancer cells use to divide and grow.

We know from research that having carfilzomib and daratumumab together might help if treatment stops working or if your myeloma comes back. But they aren’t sure, so want to find out more.

In this study, some people have carfilzomib, daratumumab and dexamethasone (a steroid drug). And some have carfilzomib and dexamethasone.

The aims of the study are to:

  • find out how well treatment works
  • see how treatment affects quality of life Open a glossary item
  • learn more about the side effects

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part
You may be able to join this study if all of the following apply.

You:

  • have myeloma that has come back or got worse after last treatment
  • have myeloma that can be measured on scan and shows up in blood or urine tests
  • have had at least 1 but no more than 3 different treatments in the past
  • have myeloma that went away a little bit (a partial response) after at least 1 previous treatment
  • are willing to use reliable contraception during the study and for up to 3 months after daratumumab or 30 days after carfilzomib if there is any chance that you could become pregnant or for up to 3 months after treatment if there is any chance that your partner could become pregnant
  • are well enough to be up and about for at least half the day (performance status 0,1 or 2)
  • have satisfactory blood tests results
  • are at least 18 years old

Who can’t take part
You cannot join this study if any of these apply.

Cancer related
You:

  • have Waldenstrom’s macroglobulinemia Open a glossary item
  • have a rare subtype of myeloma called IgM myeloma
  • have plasma cell leukaemia
  • have myelodysplastic syndrome
  • have amyloidosis Open a glossary item
  • have had  immunotherapy Open a glossary item or chemotherapy in the 21 days before starting study treatment
  • have had carfilzomib in the past and you didn’t have at least a partial response to treatment, you had to stop treatment due to side effects, your myeloma got worse within 6 months of stopping it, or it has been less than 6 months since your last dose
  • have had daratumumab or a similar drug and you didn’t have at least a partial response to treatment, you had to stop treatment due to side effects, your myeloma got worse within 6 months of stopping treatment or it has been less than 6 months since your last dose
  • have had a steroid in the 14 days before starting study treatment
  • have had radiotherapy in the 7 days before starting study treatment or 21 days if you had radiotherapy to a large area of your bone marrow
  • have had major surgery in the last month
  • have had any other cancer in the last 5 years apart from CIS Open a glossary item of the cervix, early prostate cancer, early breast cancer, medullary or papillary cancer, basal cell Open a glossary item or squamous cell skin cancer Open a glossary item, early urothelial cancer that has been successfully treated or you had cancer in the last 3 years, you have had treatment and there haven’t been any signs of it since
  • have already had daratumumab as part of a clinical trial
  • are having or have had treatment with an experimental drug or device in the last 28 days
  • have graft versus host disease Open a glossary item
  • have had a stem cell transplant Open a glossary item with your own cells in the last 90 days or with someone else’s cells in the last 100 days

Medical conditions
You:

  • have a problem with the left side of your heart and it isn’t pumping blood very well
  • have kidneys problems they don't filter urine properly
  • have a condition called POEMS syndrome  
  • have a heart or lung condition that means you are on a fluid restriction
  • have problems with your heart, such as a heart attack in the last 4 months, high blood pressure that is not well controlled, angina that is not well controlled, an abnormal rhythm of your heart, congestive heart failure
  • have an active infection
  • have fluid on the lungs (pleural effusions) or fluid collections in your body (ascites) that the doctors will need to drain in the 14 days before joining the study
  • are having treatment to dampen down your immune system Open a glossary item for graft versus host disease even if it has resolved
  • have a problem with your lungs called COPD and have moderate to severe breathing problems
  • have had moderate to severe asthma in the last 2 years or you have asthma that isn’t well controlled with medication
  • have scarring of the liver (cirrhosis)
  • have had moderate to severe tingling in your hands or feet in the 14 days before starting study treatment
  • have HIV
  • have an active hepatitis B or hepatitis C infection
  • have any other medical condition or mental health problem that the study team think would affect you taking part in this study

Other
You:

  • can’t have dexamethasone for any reason
  • are allergic to a substance called Captisol
  • can’t have daratumumab or anything it contains
  • can’t have any of the other drugs you might need during the study or you are sensitive to anti viral drugs such as oseltamivir or zanamivir
  • have had a live vaccine Open a glossary item in the last 4 weeks
  • are pregnant or breastfeeding

Trial design

This phase 3 study will take place worldwide. The study team hope 400 people will take part including 30 from the UK. It is a randomised study. You are put into 1 of the following 2 treatment groups by a computer.

  • carfilzomib and dexamethasone
  • carfilzomib, daratumumab and dexamethasone

You have a 2 in 3 chance of having daratumumab. So for every 2 people having daratumumab and carfilzomib, 1 will have carfilzomib alone.

CANDOR Diagram

Neither you nor your doctor will be able to decide which group you will be in.

You have darafatumumab and carfilzomib as a drip into a vein. You have dexamethasone tablets or you might have it as drip into a vein. You have treatment in cycles. Each 4 week period (or 28 days) is a cycle of treatment. The first day of each treatment cycle is called day 1.

Carfilzomib and dexamethasone

You have:

  • carfilzomib twice a week in the first 3 weeks of each treatment cycle - it takes 30 minutes each time
  • dexamethasone once a week

Carfilzomib, daratumumab and dexamethasone
You have:

  • carfilzomib twice a week in the first 3 weeks of each treatment cycle
  • dexamethasone once a week
  •  daratumumab in the first cycle of treatment on:
    • day 1
    • day 8
    • day 15
    • day 22
  • for cycles 3 to 6 you have daratumumab every 2 weeks and once a month after that

Everyone has treatment for as long as it is working and the side effects aren’t too bad.

Research samples
You have extra blood tests as part of this study. Where possible you have these at the same time as your routine blood tests.

The researchers want to:

  • find out what happens to the drugs in the body (pharmacokinetics Open a glossary item)
  • look for substances called biomarkers Open a glossary item to find out why treatment might work for some people and not for others.

They will look at your genetic material (DNA), in your body cells such as blood and tissue cells. They might ask for a saliva sample to do this. Knowing more about people’s genetic material might help the doctors to understand more about myeloma and how treatment works. This is known as pharmacogenetic testing.

They will also ask to use any leftover samples for research purposes. You don’t have to agree to give these research samples if you don’t want to. You can still take part in the study.

Quality of life
The study team will ask you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study Open a glossary item.

Hospital visits

You see a doctor and have some tests before you start treatment. The tests include:

  • physical examination
  • a heart scan (echocardiogram Open a glossary item)
  • heart trace (ECG) Open a glossary item
  • tests to see how well your lungs work
  • urine test
  • blood tests
  • bone marrow test
  • X-rays
  • CT scan or PET-CT scan

You have your treatment in the hospital outpatient department. You shouldn’t need to stay overnight.

Follow up appointments
When you finish treatment, you see the study doctor for a check up after:

  • a month
  • 8 weeks

You see your doctor at routine hospital appointments after that. The study team might see you at these appointments or they will check your medical notes to see how you are getting on.

Side effects

Only a few people have had carfilzomib and daratumumab together. So there might be some side effects we don’t know about yet.

The most common side effects of carfilzomib include:

  • a drop in the number of blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • shortness of breath
  • cough
  • chest infections such as pneumonia
  • diarrhoea or constipation
  • feeling or being sick
  • stomach pain
  • tiredness (fatigue)
  • fever
  • swelling of the hands, feet or ankles
  • feeling weak
  • runny or blocked nose
  • loss of appetite
  • back pain, joint pain, arm or leg pain
  • muscle spasms
  • headache
  • dizziness
  • numbness, tingling or loss of feeling in hands and feet
  • difficulty sleeping (insomnia)
  • changes in blood tests such as low levels of potassium or high blood sugar levels

The most common side effects of daratumumab include:

  • a drop in the number of blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • a reaction to the infusion such as stuffy nose, cough, chills, feeling or being sick and rarely, breathing problems. This usually happens during or within the first few hours of treatment. The doctor will keep a close eye on you and treat any problems straight away.
  • blocked nose, sinus or lung infections
  • numbness or tingling of the hands, feet, arms or legs
  • headache
  • cough
  • shortness of breath
  • diarrhoea
  • feeling or being sick
  • muscle spasms
  • tiredness (fatigue)
  • fever
  • swelling of the hands, feet or limbs

The study team will talk to you about the side effects of all treatment before you take part.

We have information about the side effects of dexamethasone.

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 James Cavet

Supported by

Amgen

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15098

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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