Active not recruitingNAINTERVENTIONAL

Multicenter Phase 2 Study of Subcutaneous Isatuximab Plus Bortezomib, Lenalidomide and Dexamethasone in the Treatment of Newly Diagnosed Transplant Ineligible Multiple Myeloma

This study is looking at a new way to give a drug called isatuximab. Currently, people receive this drug through a quick drip into a vein. This study is testing if giving a new version of the drug as an injection under the skin (like a jab) works just as well and is as safe. This new injection could be much more convenient and quicker than the current drip. The study is for people who have recently been diagnosed with multiple myeloma and are not able to have a stem cell transplant. Researchers want to see how this injected version of isatuximab, combined with other standard myeloma treatments (bortezomib, lenalidomide, and dexamethasone), helps patients. They will compare the results to what they already know about the original drip version.

At a glance

Status

Active not recruiting

Phase

Sponsor

Poitiers University Hospital

Enrolment target

Start

23 Oct 2023

Estimated completion

01 Sep 2028

Multiple Myeloma Myeloma Multiple Myeloma

What is this study about?

This research study is about finding a better way to give a medicine called isatuximab to people with a type of blood cancer called multiple myeloma. Multiple myeloma affects special cells in your bone marrow. Currently, isatuximab is given through a needle into a vein (this is called an intravenous infusion, or IV), which can take some time. The drug company has now developed an injection form of isatuximab, which can be given under your skin, similar to many other injections. This new injection is designed to be much quicker and more convenient for patients.

The study is specifically looking at patients who have recently been diagnosed with multiple myeloma and, for various health reasons, are not able to have a stem cell transplant. In this study, doctors will give the new injected isatuximab along with other standard treatments for multiple myeloma: bortezomib, lenalidomide, and dexamethasone. The main goal is to see if giving isatuximab as an injection works just as well and is as safe as the original drip version when used with these other medicines.

The doctors running this study want to learn if the injected form of isatuximab offers the same benefits as the drip form. They'll be looking carefully at how effective it is in treating the myeloma and what side effects people experience. By comparing their findings with previous studies that used the drip version, they hope to show that the new, more convenient injection is a good option for patients.

Key takeaways

This study is testing a new injected form of the myeloma drug isatuximab.
It aims to make treatment more convenient and quicker than the current drip method.
The study is for newly diagnosed multiple myeloma patients who can't have a stem cell transplant.
Isatuximab will be given with other standard myeloma medicines.
Researchers want to confirm the injection works as well and is as safe as the drip.

Who may be eligible?

To be considered for this study, you need to be at least 65 years old and have been recently diagnosed with multiple myeloma. It's important that your specific type of myeloma requires treatment and that you're not able to have a stem cell transplant. You also need to be able to take medicines by mouth.

Doctors will check your medical records to make sure you have measurable signs of myeloma, meaning they can track how well the treatment is working. This might involve checking certain protein levels in your blood or urine. They will also look at your general health to make sure you are well enough to take part and are expected to live for at least another six months.

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 at least 65 years old?
Have you recently been diagnosed with multiple myeloma?
Are you unable to have a stem cell transplant?
Can you swallow various pills and tablets?
Are you able to attend regular hospital/clinic appointments?

Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves is not fully provided here, but generally, trial participation typically includes regular visits to the hospital or clinic for check-ups, blood tests, and to receive your treatment. You would receive the study drug, isatuximab, as an injection under your skin, along with other standard oral and injected medications for your myeloma.

You would have regular assessments to monitor your health, how the treatment is working, and to check for any side effects. There would be a follow-up period after your treatment finishes to see how you are doing in the long term. The total duration of your participation, including treatment and follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving a new, potentially more convenient way of taking a proven myeloma treatment, and contributing to medical knowledge that could help future patients. However, like all medicines, the treatments have potential risks and side effects, some of which are known and others which might be unexpected. You would be closely monitored for any adverse reactions. You have the right to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

CHU Poitiers
Verified postcode
Poitiers, France

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects plasma cells, which are white blood cells found in your bone marrow.

What is isatuximab?

Isatuximab is a medicine used to treat multiple myeloma. It's usually given through a drip, but this study is testing an injection version.

Why is an injection better than a drip?

An injection under the skin is usually quicker and more convenient than a drip into a vein, which can take longer in a clinic setting.

What does 'transplant ineligible' mean?

This means that for health reasons, a person isn't suitable to have a stem cell transplant, which is another treatment option for multiple myeloma.

Will I still receive other treatments for my myeloma?

Yes, in this study, the injected isatuximab will be given alongside other standard myeloma treatments: bortezomib, lenalidomide, and dexamethasone.