A study looking at SAR445514 for myeloma
Cancer type:
Status:
Phase:
This study is looking at a drug called SAR445514 for myeloma and light chain amyloidosis.
It is open to people with myeloma and light chain amyloidosis that has come back after treatment or got worse during treatment.
Please note the study is only open to people with myeloma at the moment. We will update this summary when the study is open to people with light chain amyloidosis.
More about this trial
SAR445514 is a type of 
called a . It works by stimulating the to attack and kill cancer cells.
Researchers think it might help people with myeloma and light chain amyloidosis.
The aims of this study are to find out:
- the best dose of SAR445514 to give for myeloma and light chain amyloidosis
- how well SAR445514 works
- about the side effects of SAR445514
- what happens to SAR445514 in the body
Who can enter
The following bullet points are a summary of 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
Myeloma
You may be able to join this study if you have:
- myeloma that came back after treatment or got worse during treatment
- had at least 2
cycles of treatment of an immunotherapy such as lenalidomide or pomalidomide, dexamethasone, a proteasome inhibitor such as bortezomib, carfilzomib or ixazomib and a monoclonal antibody such as daratumumab or isatuximab. Your doctor will know more about this.
Light chain amyloidosis
You may be able to join this study if you have:
- light chain amyloidosis that came back after treatment or got worse during treatment
- had at least 1
course of treatment that included a proteasome inhibitor such as bortezomib, carfilzomib or ixazomib.
And all of the following apply. You:
- are willing to use reliable contraception during treatment and for a certain period of time after if there is any chance you or your partner could become pregnant
- can mostly care for yourself but might not be able to do your normal activities or active work (Karnofsky performance status 60 to 100)
- have satisfactory blood test results
- are at least 18 years old
For Part 1
The following must also apply. You:
- are not able to have any other treatment for your myeloma or light chain amyloidosis
- weigh between 40kg and 120kg (6st 4lb and 18st 12lb)
Who can’t take part
Myeloma related
You cannot join this study if any of these apply. You have:
- myeloma that got worse during treatment and the initial treatment didn’t work well enough. Your doctor will know about this.
- primary systemic light chain amyloidosis (AL amyloidosis)
- a rare type of myeloma called plasma cell leukaemia
Light chain amyloidosis related
You cannot join this study if any of these apply.
- You have or had symptoms of myeloma.
- Your blood pressure is less than 100mmHg over 55mmHg. Your doctor will check this.
Medical conditions
You cannot join this study if any of these apply. You have:
- another cancer apart from successfully treated
non melanoma skin cancer , a carcinoma in situ . You could join if you had cancer more than 2 years ago that was treated with the aim to cure. heart problems that could affect you taking part. Your doctor will know about this.- non light chain amyloidosis. Your doctor will know this.
- an uncontrolled infection within 2 weeks of starting treatment. You are taking anti retroviral medication for HIV. You have active hepatitis A, uncontrolled or active hepatitis B or active hepatitis C.
- had treatment for myeloma including dexamethasone within 2 weeks of starting treatment
graft versus host (GvHD) after having a stem cell transplant from a donor . You are taking drugs that damp down your immune system to treat GvHD within 2 months before randomisation in this study. - had major surgery, plasmapheresis, radiotherapy or any other major procedure within 2 weeks of starting treatment
- had an anti CD38 monoclonal antibody such as isatuximab or daratumumab within 3 months of starting treatment
- had treatments called anti BMCA such as CAR T-cell or antibody drug conjugate within 3 weeks of starting treatment. Your doctor will know more about this.
- ongoing side effects of any other treatment unless they are mild
- had treatment as part of a clinical trial within the past 28 days
- any other medical condition or mental health problem that could affect you taking part
Other
You cannot join this study if any of these apply. You:
- cannot take dexamethasone
- are allergic or sensitive to any of the treatments used in this study or any of their ingredients
- have a social problem or are in a social situation that could affect you taking part
- have a
live vaccine within 4 weeks of starting treatment. The COVID-19 and seasonal flu vaccines are not live vaccines. - are pregnant or breastfeeding
Trial design
This is an international phase1/2 study.
There are 3 parts to this study. Only Part 1 is open to recruitment for people with myeloma at the moment. We will update this summary when Part 1 is open to people with light chain amyloidosis. And when the other parts of the study are opened to recruitment.
Part 1 - currently only recruiting people with myeloma
In this part the team need up to 30 people with myeloma to take part.
The team want to find the 2 best doses to give for myeloma.
To do this the first few people have a small dose. If they don’t have any serious side effects, the next few people have a higher dose. And so on until the team find the 2 best doses for people with myeloma.
When this part is open to people with light chain amyloidosis the team want to find the best dose for these people. We will update this summary when it is open to people with light chain amyloidosis.
Part 2 - currently not open
In this part the team want to find out more about which of the 2 doses is best for people with myeloma. And more about the best dose for people with light chain amyloidosis.
We will update the summary when this part is open to recruitment.
Part 3 - currently not open
In this part the team want to find out how well the doses of SAR445514 work for people with myeloma and people with light chain amyloidosis. This part is not yet open to recruitment. When it is open we will update this summary.
How you have SAR445514
You have SAR445514 as an injection under the skin (subcutaneous). Each injection takes between 6 and 20 minutes. You have treatment in cycles. Each is 4 weeks (28 days).
Cycle 1
You have SAR445514 once each week in this cycle.
Cycles 2 to 12
You have SAR445514 once on the first day of the cycle and on the 15th day of the cycle.
Following cycles
You have SAR445514 once on week 1 of the cycle.
Medication before having SAR445514
Before having SAR445514 you have medication to reduce the risk of having a reaction to it. Some of these you take by mouth and some you have as a drip into a vein. Your doctor will tell you more about this before you agree to take part.
You have SAR445514 as long as it is working and the side effects aren’t too bad.
Samples for research
You give blood samples during the study. Where possible the team take these samples when you have blood tests as part of your routine care. Your doctor can tell you more about how often you give these samples.
The researchers use these blood samples to:
- find out what happens to SAR445514 in the body
- find out how SAR445514 affects the body
- find out whether the body makes
antibodies due to having SAR445514 - look for substances in the blood (
biomarkers ) that could tell how well SER445514 is working and how to reduce the side effects
Questionnaires
You fill in a questionnaire twice during treatment and once after treatment. The questions ask about the treatment and what advantages or disadvantages you think it has.
Hospital visits
You see the doctor for tests. These include:
- a
physical examination - blood tests
- urine test
- heart trace (ECG)
- heart scan (ECHO)
- ultrasound scan of the heart
- a scan such as a CT scan, an MRI scan or a PET-CT scan
- bone marrow test
For the first 3 treatments of SAR445514 you stay in hospital. This is so the healthcare team can monitor you.
During treatment you see the doctor regularly to see how you are and for blood tests. You might also have a scan and ultrasound of the heart. Your doctor will tell you if you do and how often you will have them.
At the end of treatment you see the doctor to see how you are and for:
- blood tests
- heart trace
- ultrasound of the heart
Follow up
After treatment has finished you see the doctor every 4 weeks until your myeloma or amyloidosis starts to get worse. You then see them every 3 months.
During treatment if your myeloma or amyloidosis gets worse you see the doctor every 3 months.
You might have scans and an ultrasound of the heart. Your doctor will tell you if you do and how often you have them.
Side effects
The study team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
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SAR445514 can affect the These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for. |
This is the first time SAR445514 has been used to treat people. So the side effects aren’t known. Some side effects that might happen could include the following.
A reaction to the study drug
This could happen up to 24 hours after having the injection and most commonly happens after the first injections. The symptoms include:
- chills
- feeling sick
- shortness of breath
- chest discomfort
- flushing
- cough
- headache
- redness, pain and itching at the injection site
Cytokine release syndrome
In some people their immune system can release substances called cytokines into the blood when they have a drug. The symptoms include:
- feeling like you have the flu
- chills
- high temperature
- low blood pressure
- rapid heartbeat
- headache
- skin rash
- confusion
Tumour lysis syndrome
This is when you have changes to the levels of substances in your blood, due to the breakdown of cancer cells. It usually happens when you first start treatment, but you have regular blood tests to check for this.
It can cause damage to your organs such as the heart and kidneys. And can be very serious.
Other possible side effects
These may include:
- infections such as lung infections
- reactivation of previous virus infections such as herpes and hepatitis
Your doctor will talk to you about the possible side effects of the treatment and answer any questions you have before you agree to take part.
Location
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 Emma Searle
Supported by
Sanofi
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
