RecruitingPHASE3INTERVENTIONAL

A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant

This study is looking into a new medication called linvoseltamab for adults recently diagnosed with multiple myeloma. Multiple myeloma is a cancer that affects plasma cells in your bone marrow. This research focuses on patients who are not suitable for a special type of treatment called a stem cell transplant. The main goal is to compare linvoseltamab with the usual treatments to understand how well it works and if it has any side effects. By joining, you could help doctors learn if this new drug is a better option for people with this condition, potentially leading to improved care in the future. It’s important to remember that this is a research study, and while we hope for positive results, safety is always a top priority.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

European Myeloma Network B.V.

Enrolment target

1,000

Start

23 Dec 2025

Estimated completion

01 Dec 2036

Multiple Myeloma

What is this study about?

This study is about a new possible treatment for a type of blood cancer called multiple myeloma. If you've recently been diagnosed with multiple myeloma and your doctor has said that a stem cell transplant isn't the right option for you, this study might be relevant. We're looking at a new drug called linvoseltamab, and we want to see how it compares to the treatments doctors usually give for this condition. The main aim is to understand if linvoseltamab is safe and if it works better than what's currently available.

Multiple myeloma affects certain white blood cells in your bone marrow, and it can cause various health problems. Standard treatments aim to control the cancer and improve your quality of life. This research is important because it explores a new option that could potentially offer a different way to manage the disease, especially for those who can't receive a stem cell transplant. By joining a study like this, you would be helping medical science learn more about multiple myeloma and how to treat it effectively for a wider range of patients.

Being part of a clinical trial means you'll receive careful medical attention and your health will be monitored closely throughout. The researchers will be comparing linvoseltamab with other drugs like daratumumab, lenalidomide, and dexamethasone, which are existing treatments for multiple myeloma. This comparison will help us get a clear picture of the new drug's potential benefits and side effects. All steps are taken to ensure your safety and well-being during the study.

Key takeaways

Tests a new drug (linvoseltamab) for multiple myeloma.
Compares it to standard treatments for safety and effectiveness.
For adults with newly diagnosed multiple myeloma who can't have a transplant.
Participation involves regular checks and close medical monitoring.
You have the right to withdraw from the study at any time.
Could help improve future treatments for multiple myeloma.

Who may be eligible?

To join this study, you must have a confirmed diagnosis of multiple myeloma that is causing symptoms. Your doctor must also confirm that a high-dose chemotherapy and stem cell transplant is not a suitable treatment for you. You also need to have clear signs of the disease that doctors can measure.

There are some reasons why you might not be able to join. For example, if you have certain other specific health conditions or if you've already had treatment for multiple myeloma. If you decide not to have a transplant just because you prefer not to, you also wouldn't be able to join this particular study. Your doctor will carefully check all your medical information to see if this study is an option for you.

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.

Have you been diagnosed with multiple myeloma that is causing symptoms?
Has your doctor said you are not suitable for a stem cell transplant?
Do you have signs of the disease that doctors can measure?
Are you generally well enough to participate in a study, as assessed by your doctor?
Have you not had previous treatment for multiple myeloma (with very few exceptions)?
Do you have no other serious health conditions that would prevent participation?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic for check-ups and assessments. You would receive either the experimental drug, linvoseltamab, or a standard treatment for multiple myeloma, which could include daratumumab, lenalidomide, and dexamethasone. The specific schedule for your medication and visits would be explained to you by the study team. You would also have blood tests and other examinations to monitor your health and how the treatment is working. We cannot give a precise total duration as this varies by study, but the study team will provide you with all timeline details. You'll be closely supported by the study team throughout your participation.

Potential risks and benefits

Participating in this study might offer you access to a new treatment before it's widely available, which could potentially be beneficial for your condition. You will also receive very close medical attention and monitoring. However, like all medications, the study drugs can have side effects, and some are not yet fully known for linvoseltamab. There's also no guarantee that the new treatment will work better than existing ones, or even work at all. Before joining, the study team will explain all known potential risks and side effects in detail. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (59)

Flinders Medical Centre
Verified postcode
Adelaide, Australia· Recruiting
Box Hill Hospital
Verified postcode
Box Hill, Australia· Recruiting
Canberra Hospital
Verified postcode
Canberra, Australia· Recruiting
Barwon Health, University Hospital Geelong
Verified postcode
Geelong, Australia· Recruiting
Austin Hospital
Verified postcode
Heidelberg, Australia· Recruiting
Nepean Cancer Centre
Verified postcode
Kingswood, Australia· Recruiting
Northern Hospital
Verified postcode
Melbourne, Australia· Recruiting
Sunshine Coast Health
Verified postcode
Sunshine Coast, Australia· Recruiting
Ordensklinikum Linz
Verified postcode
Linz, Austria· Recruiting
Klinik Ottakring
Verified postcode
Vienna, Austria· Recruiting
University Hospital Centre Zagreb - Clinic for Internal Medicine
Verified postcode
Zagreb, Croatia· Recruiting
Fakultni Nemocnice Hradec Kralove
Verified postcode
Hradec Králové, Czechia· Recruiting

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that starts in the plasma cells in your bone marrow, which are part of your immune system.

What is a stem cell transplant?

A stem cell transplant is an intensive treatment that replaces damaged or diseased bone marrow with healthy stem cells. This study is for people who can't have this particular treatment.

Is linvoseltamab a new drug?

Yes, linvoseltamab is an investigational drug, which means it is still being studied to see its safety and effectiveness before it can be widely used.

Will I definitely receive the new drug if I join?

This study compares the new drug with standard treatments. You might receive linvoseltamab, or you might receive one of the standard treatments. The study team will explain this to you.

Who is funding this study?

The information provided does not specify the funding source, but clinical trials are typically sponsored by pharmaceutical companies or research organisations.

How to find out more

Silvia Villa

silvia.villa@emn.org +31 10 268 70 65 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.