A study of AUTO2 for myeloma (APRIL)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
- chemotherapy
- targeted cancer drugs (biological therapy)
- steroids
More about this trial



- the best safe dose of AUTO2 to give
- what the side effects are
- how safe it is
- how well it works for myeloma
Who can enter
- you have myeloma that can be measured with a blood test or urine test
- your myeloma has come back or continued to grow after at least 3 different types of treatment including a targeted cancer drug, such as bortezomib or carfilzomib and an immunotherapy, such as thalidomide, lenalidomide or pomalidomide or you have had both a targeted drug and immunotherapy and your myeloma continued to get worse within 2 months
- you are able to do everything apart from heavy physical work (performance status 0 or 1)
- you weigh more than 30kg (4 stone)
- you have satisfactory blood test results
- you are willing to use 2 types of reliable contraception during the study and for at least a year afterwards if you or your partner could become pregnant and you must also agree not to donate your eggs or sperm during the study and for at least a year afterwards
- you are at least 18 years old
- have myeloma that has spread to your brain or spinal cord and is causing symptoms
- have previously been diagnosed with systemic light chain
amyloidosis - have had a donor (
allogenic ) stem cell transplant
- have had anti myeloma treatment within the 7 days before your pre conditioning treatment or leukapheresis
- have had radiotherapy within 7 days of pre conditioning treatment or leukapheresis apart from radiotherapy to a single local area for example for bone pain
- have had another cancer apart from treated
in situ carcinoma of the cervix, successfully treated
non melanoma skin cancer or any other cancer that has been successfully treated and there hasn’t been any sign of it in the past 2 years and there is a very small risk of it coming back
- aren’t able to have cyclophosphamide, fludarabine,
albumin or dimethyl sulfoxide (DMSO)
- have already had
gene therapy or other cell therapy treatment
- have had rituximab or a similar drug within the 3 months before having AUTO2 treatment
- a heart problem such as angina, heart failure or arrhythmias that isn’t controlled by medication
- had a heart attack in the past 6 months
- heart problems so it isn’t working well enough
- had a stroke in the past 3 months
- high blood pressure that isn’t controlled by medication
- high blood pressure that has affected other body organs or has caused headaches
- had blood clots (DVTs) or a blood clot on the lung and you are taking medication to prevent further blood clots such as warfarin
- bleeding from your gut
- had major surgery in the past 3 months
- liver problems
- kidney problems and need to have dialysis
- an infection or a virus that needs treatment
- HIV, hepatitis B, hepatitis C, HTLV 1, HTLV 2 or syphilis
- an
autoimmune disease and you take medication that affects your
immune system
- are taking more than 5mg of prednisolone daily or an equal dose of another
steroid that can’t be stopped
- have any other medical or mental health condition that your doctor thinks could affect you taking part in the study
- are pregnant or breastfeeding
Trial design
- you have a severe infection when you are due to have treatment
- you need to have oxygen
- you have pus, blood or similar substances in your lungs when you are due to have treatment
- your liver or kidneys aren’t working well enough
Hospital visits
- a physical examination
- blood tests
- heart trace (
ECG )
- heart scan (
MUGA or
ECHO )
- CT scan or PET-CT scan or MRI scan
- urine test (24 hour urine collection)
- bone marrow test
- a physical examination
- blood tests
- blood tests
- a physical examination
- 24 hour urine collection
- bone marrow test
- a physical examination
- blood tests
- 24 hour urine collection
- to see how you are
- for blood tests
- a physical examination
- a physical examination
- blood tests
- 24 hour urine collection
- heart trace (ECG)
- bone marrow test
- 3 months
- 6 months
- 12 months
- 18 months
- 24 months
Side effects
- feeling lightheaded
- a drop in the level of calcium in your blood causing numbness and tingling particularly in the hands, feet and around the mouth. It can also cause muscle spams
- high temperature (fever)
- shivering
- difficulty breathing and wheezing
- rash
- high temperature
- aching muscles
- low blood pressure
- difficulty breathing
- confusion
- difficulty speaking
- difficulty writing
- decreased alertness
- fits
- a drop in blood cells making you at an increased risk of getting an infection, feeling tired, bruising and bleeding
- an increased risk of developing another cancer and other blood conditions
- feeling or being sick
- tummy (abdominal) cramps
- headaches
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.
Chief Investigator
Dr Rakesh Popat
Supported by
Autolus Limited
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040