A randomized phase III non-inferiority trial assessing lenalidomide, bortezomib and dexamethasone induction therapy with either intravenous or subcutaneous isatuximab in transplant-eligible patients with newly diagnosed multiple myeloma (GMMG HD8/ DSMM XIX)
This study is for people recently diagnosed with multiple myeloma, a cancer affecting certain white blood cells. It's testing if a new way of giving a medicine called isatuximab is as effective as the current way. Isatuximab is given alongside other standard treatments like lenalidomide, bortezomib, and dexamethasone. Researchers want to see if giving isatuximab as an injection under the skin (subcutaneous) works just as well as giving it through a drip into a vein (intravenous). This is important because injections can often be more convenient for patients. The study will look at how well the treatments shrink the cancer and how patients feel about the different ways of receiving the medicine.
At a glance
What is this study about?
This study is focused on improving treatment for multiple myeloma, a type of cancer that develops from plasma cells in the bone marrow. When you're first diagnosed and eligible for a stem cell transplant, doctors usually start with a combination of powerful medicines to reduce the cancer cells before the transplant. This study is looking at one of these combinations, which includes lenalidomide, bortezomib, and dexamethasone.
The exciting part of this study is that it's introducing a new medicine called isatuximab. Isatuximab is designed to target cancer cells more specifically. The researchers want to find out if giving this medicine as a simple injection under the skin (much like an insulin shot) is just as effective as giving it through a drip directly into your vein. If the injection works just as well, it could make treatments much easier and more comfortable for patients in the future.
Ultimately, the main goal is to see how much the cancer shrinks after this initial treatment. They will compare the two ways of giving isatuximab to see if one is better or if they are equally effective at preparing patients for a potential stem cell transplant. They are also interested in how satisfied patients are with their treatment, especially regarding the difference between having an injection versus a drip.
Key takeaways
- This study is for adults newly diagnosed with multiple myeloma who may be considered for a stem cell transplant.
- It's comparing two ways of giving a medicine called isatuximab: through a drip or as an injection.
- The main aim is to see if the injection works just as well as the drip in shrinking the cancer.
- Patients' satisfaction with their treatment will also be measured.
- Your doctors will explain all the treatments and potential side effects in detail.
Who may be eligible?
This study is open to adults aged 18 and over, of any gender. You would need to have been recently diagnosed with multiple myeloma, and your doctors must believe you are healthy enough to potentially have a stem cell transplant as part of your treatment plan.
More specific details about your diagnosis and general health would be checked by the study team to make sure this trial is the right fit for you. This is to ensure your safety and that the results of the study are clear and reliable.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you recently been diagnosed with multiple myeloma?
- Are your doctors considering you for a stem cell transplant?
- Are you willing to receive one of two ways of getting the study medication (drip or injection)?
- Are you able to attend regular hospital visits for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you will receive a combination of medicines: lenalidomide (tablets), bortezomib (injections), and dexamethasone (tablets). You will also receive the new medicine, isatuximab. Some participants will receive isatuximab through a vein (intravenously, meaning a drip), while others will receive it as an injection under the skin (subcutaneously).
You will have regular hospital visits for these treatments and to monitor your health. This will involve blood tests, physical examinations, and possibly bone marrow samples, similar to what you would have with standard multiple myeloma care. The study will also ask you to fill out questionnaires about how you feel about your treatment, especially regarding convenience and satisfaction. The exact duration of your participation, including follow-up, will be explained fully by the study team.
Potential risks and benefits
Locations (2)
- —UnverifiedAustria
- —UnverifiedGermany
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in your bone marrow.
What is a 'phase III' trial?
A phase III trial usually compares a new treatment or approach with the best standard treatment available, to see if it is just as good, or better.
What does 'transplant-eligible' mean?
This means your doctors believe you are healthy enough to potentially have a stem cell transplant, which is a common treatment for multiple myeloma.
What is the main question this study is trying to answer?
The study wants to know if giving the medicine isatuximab as an injection under the skin works just as well as giving it through a drip, when combined with other standard myeloma treatments.
Will I definitely get the new injection method?
This is a 'randomized' study, meaning you will be randomly assigned to either receive isatuximab as a drip or as an injection. Neither you nor your doctor can choose which one you receive.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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