AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants with Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma

Smoldering multiple myeloma is an early stage of blood cancer that does not yet cause symptoms. However, people with the 'high-risk' type are more likely to develop active multiple myeloma soon. Historically, doctors often watched and waited before starting treatment. This Phase 3 trial compares two treatments to see if early action can prevent the disease from getting worse. Participants will be randomly chosen to receive either linvoseltamab (a newer targeted immunotherapy) or daratumumab (a standard antibody treatment given by injection). Both medicines help the body's immune system locate and destroy abnormal plasma cells. Doctors want to see which drug keeps people free from active disease for longer, how well each drug removes signs of abnormal cells, and how the treatments affect daily quality of life.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Regeneron Pharmaceuticals Inc.

Enrolment target

108

Start

20 Aug 2026

High Risk Smoldering Multiple Myeloma (HR-SMM)

What is this study about?

Multiple myeloma is a type of blood cancer that affects plasma cells inside the bone marrow. Before active myeloma develops, people often go through a quiet stage called smoldering multiple myeloma. In this stage, there are abnormal cells in the bone marrow, but they have not yet caused bone damage, kidney problems, or low red blood counts. When doctors assess this condition as 'high risk', it means tests show a greater chance that it will become active cancer in the near future.

In the past, the usual approach was to monitor patients closely and only begin treatment once clear symptoms appeared. Today, doctors are investigating whether early treatment can clear abnormal cells and stop the cancer from waking up. This trial compares two medicines: linvoseltamab and daratumumab.

Daratumumab is an established medicine that binds to a specific protein on myeloma cells so the immune system can destroy them. Linvoseltamab is a newer type of drug known as a bispecific antibody. It works like a bridge, bringing your body's own disease-fighting immune cells directly to the abnormal myeloma cells to help kill them. By comparing the two, researchers hope to find the most effective and safest way to protect people at high risk.

Key takeaways

Phase 3 trial comparing linvoseltamab to daratumumab.
Aimed at adults with high-risk smoldering multiple myeloma.
Tests whether early treatment can prevent or delay active blood cancer.
You will be randomly assigned to receive one of the two medicines.
Includes regular hospital visits, blood tests, scans, and health checks.
Participation is completely voluntary and you can stop at any time.

Who may be eligible?

This study is open to men and women aged 18 and over who have been diagnosed with smoldering multiple myeloma that doctors consider 'high risk'. High risk is determined through specific blood tests, urine tests, and bone marrow checks that show the abnormal cells are active enough to likely cause problems soon.

To take part, you must not have developed full, active multiple myeloma. This means you should not have significant organ damage caused by the disease, such as serious bone thinning, kidney failure, or high calcium levels in the blood.

Your general health also needs to be stable enough to safely receive the study treatments. Your doctor and the trial team will perform health checks to make sure your heart, liver, and kidneys are working well before you can join.

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.

I am aged 18 or older.
I have been diagnosed with smoldering multiple myeloma.
My doctor has told me my condition is considered 'high risk'.
I do not have active myeloma symptoms or major organ damage.
I am well enough to attend regular hospital appointments for treatment and tests.

Answer every question to see your result.

What does participation involve?

If you join the trial, a computer will randomly place you into one of two groups: one group receives linvoseltamab, and the other receives daratumumab. Neither you nor your doctor can choose the group. Daratumumab is usually given as a quick injection under the skin, while linvoseltamab is given into a vein. You will visit a hospital clinic regularly for your treatments and health checks. During your visits, the medical team will take blood and urine samples, carry out regular scans, and occasionally perform bone marrow checks to see how well the medicine is working. You will also be asked to fill in simple questionnaires about your energy levels, mood, and day-to-day well-being. The trial lasts for several years, continuing as long as the treatment helps you and does not cause troublesome side effects.

Potential risks and benefits

Taking part could help delay or prevent your condition from turning into active myeloma, and you will be looked after very closely by blood cancer specialists. However, both medicines can cause side effects. Common risks include tiredness, higher risk of infections, allergic reactions during treatment, and temporary drops in normal blood cell counts. Linvoseltamab can also cause an immune reaction that leads to flu-like symptoms, such as fevers. Joining the trial is entirely your choice. If you decide to take part, you are free to stop and leave the study at any time without giving a reason, and your regular NHS medical care will not be affected.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Spain
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Unverified
Poland
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Unverified
France
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Unverified
Norway
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Unverified
Greece
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Unverified
Germany

Common questions

What does 'smoldering' multiple myeloma mean?

It means abnormal cells are present in your bone marrow, but they are not yet causing noticeable damage or symptoms. It is like an early warning sign that cancer could develop.

Can I pick which drug I will receive?

No. Participants are placed into treatment groups at random by a computer. This ensures the comparison between the two medicines is fair and scientifically sound.

Will I have to pay for the trial treatments?

No. The trial medicines and any extra study tests are provided free of charge, though you may need to travel to a specialist hospital.

What happens if my condition worsens during the trial?

Your team will monitor your blood and scans closely. If there are signs that the disease is turning into active cancer, you will stop the trial drug and be offered standard cancer treatments straight away.

Can I leave the study if I change my mind?

Yes. You can leave the study at any point. Your decision will never affect your relationship with your doctors or the quality of your regular NHS care.