A study of carfilzomib and daratumumab for myeloma (CANDOR)

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
• have a rare subtype of myeloma called IgM myeloma
• have plasma cell leukaemia
• have myelodysplastic syndrome
• have amyloidosis
• have had  immunotherapy  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  of the cervix, early prostate cancer, early breast cancer, medullary or papillary cancer, basal cell  or squamous cell skin cancer , 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
• have had a stem cell transplant  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  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  in the last 4 weeks
• are pregnant or breastfeeding