RecruitingPHASE3INTERVENTIONAL

A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)

This research study is comparing two medicines, linvoseltamab and daratumumab, for people diagnosed with High-Risk Smoldering Multiple Myeloma (HR-SMM). This is a 'pre-cancer' condition where some abnormal cells are present, but it hasn't yet turned into active cancer. The main goal of the study is to see if linvoseltamab can delay or prevent HR-SMM from developing into active multiple myeloma, compared to daratumumab. Researchers will also be looking closely at any side effects the drugs might cause, how the drugs work in the body, and if the body's immune system reacts to them. Your participation could help doctors learn more about the best ways to treat this condition.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Regeneron Pharmaceuticals

Enrolment target

270

Start

21 May 2026

Estimated completion

27 Jul 2033

High Risk Smoldering Multiple Myeloma (HR-SMM)

What is this study about?

This study is for people who have been diagnosed with a condition called High-Risk Smoldering Multiple Myeloma (HR-SMM). Smoldering Multiple Myeloma is a condition where abnormal cells are found in the bone marrow, but it's not yet active cancer and usually doesn't cause symptoms. However, for some people, especially those classed as 'High-Risk,' there's a higher chance it could develop into active Multiple Myeloma over time. Doctors want to find the best ways to prevent this progression.

In this study, researchers are comparing two different medicines: linvoseltamab (which is a new, experimental drug) and daratumumab (a drug already used for some blood cancers). The main aim is to see if linvoseltamab is better at delaying or stopping HR-SMM from turning into active Multiple Myeloma. This could offer a new and improved treatment option for people with this condition.

The study will also carefully check for any side effects from these medicines. Researchers will also look at how the drugs behave in your body and if your body develops a reaction to them. By taking part, you would be helping doctors and scientists learn more about HR-SMM and potential new treatments, which could benefit many patients in the future.

Key takeaways

This study compares two drugs for High-Risk Smoldering Multiple Myeloma (HR-SMM).
It aims to see if a new drug, linvoseltamab, is better at preventing HR-SMM from becoming active cancer.
Participation involves regular clinic visits for medication and health checks.
You would receive either linvoseltamab or daratumumab by chance.
Your involvement could help improve future treatments for HR-SMM patients.

Who may be eligible?

To join this study, you would need to be an adult (age 18 or older). You must have a confirmed diagnosis of High-Risk Smoldering Multiple Myeloma (HR-SMM) according to specific medical guidelines. You should also generally be well enough to take part in a study, meaning you can carry out your normal daily activities without much difficulty.

There are certain reasons why you might not be able to join. For example, if your HR-SMM has already developed into active Multiple Myeloma, or if you have other specific blood conditions or certain neurological problems. You also cannot have had any previous treatment for a plasma cell disorder (like chemotherapy, radiotherapy, or other similar drugs). This study focuses on people who haven't started treatment yet.

The research team will carefully review all your medical information to make sure the study is right for you and that you meet all the necessary requirements.

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?
Do you have a diagnosis of High-Risk Smoldering Multiple Myeloma?
Have you *never* received any treatment for a plasma cell disorder (like previous chemotherapy or similar drugs)?
Do you feel generally well enough to go about your daily life without significant problems?
Have you *not* been diagnosed with active Multiple Myeloma or other specific related blood conditions?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be assigned to receive either linvoseltamab or daratumumab. You won't get to choose which medicine you receive. This is done by chance, like flipping a coin, to ensure a fair comparison. You will have regular visits to the clinic for medical check-ups, blood tests, and to receive your study medicine.

The study medicine will likely be given as an infusion into a vein. During these visits, doctors and nurses will monitor your health closely, check for any side effects, and make sure the treatment is safe for you. You'll also have follow-up appointments even after you stop taking the study medicine, so doctors can continue to track your health over time. The full duration of your involvement, including follow-up, will be explained by the study team.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as gaining access to a new, experimental drug that might be more effective in delaying your condition. You will also receive very close medical monitoring from a team of specialists. However, there are also potential risks, including side effects from the medications. The doctors and nurses will explain all known and possible side effects to you. It's important to remember that you have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (20)

Mayo Clinic Phoenix, Mayo Clinic Building
Verified postcode
Phoenix, United States· Recruiting
Emory University - Winship Cancer Institute
Verified postcode
Atlanta, United States· Recruiting
Dana Farber / Harvard Cancer Center
Verified postcode
Boston, United States· Recruiting
Barbara Ann Karmanos Cancer Institute - Detroit
Verified postcode
Detroit, United States· Recruiting
Mayo Clinic
Verified postcode
Rochester, United States· Recruiting
Washington University School of Medicine in St. Louis
Verified postcode
St Louis, United States· Recruiting
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States· Recruiting
Ohio State University
Verified postcode
Columbus, United States· Recruiting
Nagoya City University Hospital
Verified postcode
Nagoya, Japan· Recruiting
National Hospital Organization Okayama Medical Center
Verified postcode
Okayama, Japan· Recruiting
Tokushima Prefectural Central Hospital
Verified postcode
Tokushima, Japan· Recruiting
Yamanashi Prefectural Central Hospital
Verified postcode
Kofu, Japan· Recruiting

Common questions

What is 'Smoldering Multiple Myeloma'?

It's a condition where you have some abnormal cells in your bone marrow, but it's not yet active cancer and usually doesn't cause symptoms.

What does 'High-Risk' mean in this study?

It means you have a higher chance of your Smoldering Multiple Myeloma turning into active Multiple Myeloma over time, so doctors are looking for ways to prevent this.

What are linvoseltamab and daratumumab?

They are types of medicines. Daratumumab is already used for some blood cancers, and linvoseltamab is a new drug being tested in this study.

Will I know which drug I am receiving?

No, you won't know which drug you are getting. This is a common practice in studies to make sure the results are unbiased and reliable.

What happens if my condition gets worse during the study?

The study team will monitor you closely. If your condition changes or if you develop active Multiple Myeloma, you will receive appropriate medical care, and your participation in the study may be reviewed.

How to find out more

Clinical Trials Administrator

clinicaltrials@regeneron.com 844-734-6643 Official trial record

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