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RecruitingPHASE3INTERVENTIONAL

A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

This research is investigating a new medication called linvoseltamab, either by itself or combined with another existing drug, carfilzomib. It's for adults with multiple myeloma that has returned or stopped responding to previous treatments. The study aims to see if linvoseltamab is safer and more effective than current standard treatments. Researchers will compare these new approaches to several established drug combinations. They want to find out if linvoseltamab can lead to longer and deeper remissions, which could help people live longer. They'll also be carefully checking for any side effects, how the drug acts in the body, and if the body's immune system reacts to it.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Regeneron Pharmaceuticals
Enrolment target
915
Start
02 Jan 2026
Estimated completion
23 Aug 2034

What is this study about?

This study is focused on people living with multiple myeloma, a type of blood cancer, where their treatment hasn't worked as well as hoped, or the cancer has come back. This is often called 'relapsed and/or refractory multiple myeloma' or RRMM. The main goal is to explore a new drug called linvoseltamab. Researchers are comparing it in two ways: either taken on its own, or combined with another multiple myeloma drug called carfilzomib.

These new treatment approaches (linvoseltamab alone or with carfilzomib) are being carefully compared against several established, standard treatments that doctors currently use for multiple myeloma. The study wants to find out if the new drug, linvoseltamab, can offer better results. This means looking for treatments that are not only safe but also more effective, leading to a stronger and longer-lasting control of the cancer, which could help people live longer and improve their quality of life.

Beyond simply checking if the new drug works, the study also has other important questions. Researchers will be keeping a close eye on any side effects that might happen. They'll also track how the drug moves through the body over time to understand the best way to give it. Finally, they'll check if the body's immune system sees the new drug as foreign and tries to fight it off, as this could make the drug less effective or cause other problems.

Key takeaways

  • This study explores a new drug, linvoseltamab, for multiple myeloma that's returned or not responding.
  • It aims to see if linvoseltamab, alone or with carfilzomib, is safer and more effective than current standard care.
  • The research will check for side effects and how the drug works in the body.
  • Participation involves regular checks and medication, with careful monitoring by the study team.
  • Joining could offer access to new treatments, but potential risks and side effects exist.

Who may be eligible?

To be considered for this study, you must be an adult with multiple myeloma that has either returned or stopped responding to treatment. You should have already tried at least one, but no more than three, different treatments for your myeloma. These previous treatments must have included specific types of drugs: lenalidomide, and another called either a 'proteasome inhibitor' or an 'anti-CD38 monoclonal antibody'. Your general health and how well you can do daily activities will also be assessed, usually by a doctor, and this rating needs to be at a certain level. It's also important that your myeloma has shown signs of getting worse recently, even with your most recent treatment.

There are also some reasons why you might not be able to join the study. If you've previously had a specific type of immune treatment for your myeloma that directly targets something called BCMA on your cancer cells (like certain T-cell therapies), then this study wouldn't be suitable for you. However, if you've had a different type of drug that targets BCMA, called an 'antibody-drug conjugate', that's generally acceptable.

Other reasons for not being able to join include having certain related conditions like plasma cell leukaemia or a specific type of amyloidosis. If your myeloma has spread to your brain or spinal cord, or if you have a history of certain nerve or brain conditions, you would also not be able to participate. The study team will review your full medical history in detail to make sure it's safe and appropriate for you to take part.

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.

  1. Are you an adult with multiple myeloma?
  2. Has your multiple myeloma come back or stopped responding to previous treatments?
  3. Have you had at least 1, but no more than 3, previous treatments for your myeloma?
  4. Did your previous treatments include lenalidomide and either a Proteasome Inhibitor or an anti-CD38 antibody?
  5. Do you not have specific types of previous T-cell based immune therapies for myeloma?
  6. Have you *not* been diagnosed with certain other serious related conditions (like plasma cell leukaemia) or myeloma that has spread to the brain?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive either linvoseltamab (on its own or with carfilzomib) or one of the standard multiple myeloma treatments. You'll have regular hospital visits for check-ups, blood tests, and to receive your medication. These visits will help the doctors monitor your health, how your body is reacting to the treatment, and how well the treatment is working against your myeloma. The study will also involve collecting blood samples at various times to see how the study drug is handled by your body and to check for any immune reactions. The total length of your participation in the study will depend on how you respond to the treatment and the study's follow-up schedule, which could be for several years.

Potential risks and benefits

Taking part in this study could offer you access to a new treatment, linvoseltamab, which might work better than current options for your multiple myeloma. It could potentially lead to a stronger and longer-lasting response to treatment, possibly extending your life. However, like all medications, linvoseltamab or the combination treatments could have side effects, and some might be serious. The study team will closely monitor you for any problems. You have the right to withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (16)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Memorial Sloan Kettering Cancer Center
    Verified postcode
    New York, United States· Recruiting
  • OhioHealth
    Verified postcode
    Columbus, United States· Recruiting
  • Mater Misericordiae Ltd
    Verified postcode
    Brisbane, Australia· Recruiting
  • Gold Coast Hospital and Health Service
    Verified postcode
    Southport, Australia· Recruiting
  • Chonnam National University Hwasun Hospital
    Verified postcode
    Hwasun, South Korea· Recruiting
  • Seoul National University Hospital
    Verified postcode
    Seoul, South Korea· Recruiting
  • Severance Hospital; Division of Hematology
    Verified postcode
    Seoul, South Korea· Recruiting
  • Samsung Medical Center
    Verified postcode
    Seoul, South Korea· Recruiting
  • Seoul St. Mary's Hospital, The Catholic University of Korea
    Verified postcode
    Seoul, South Korea· Recruiting
  • Ulsan University Hospital
    Verified postcode
    Ulsan, South Korea· Recruiting
  • Aberdeen Royal Infirmary
    Verified postcode
    Aberdeen, United Kingdom· Recruiting
  • Royal Cornwall Hospital National Health Service (NHS) Foundation Trust
    Verified postcode
    Truro, United Kingdom· Recruiting

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. These abnormal cells can build up and cause problems in the bones, kidneys, and blood.

What does 'relapsed and/or refractory' mean?

'Relapsed' means the cancer has come back after a period of improvement. 'Refractory' means the cancer hasn't responded to previous treatments or has continued to grow despite treatment.

What is linvoseltamab?

Linvoseltamab is a new drug being investigated for multiple myeloma. It's designed to help your immune system find and fight the cancer cells.

Will I definitely get the new drug?

Not necessarily. This study compares different treatments. You might receive linvoseltamab (alone or with carfilzomib) or one of the standard treatments. Which one you get will be decided by chance, like flipping a coin.

What are 'standard treatments'?

Standard treatments are the established and generally accepted medications or combinations of medications currently used by doctors for multiple myeloma that has relapsed or is refractory.

How to find out more

Clinical Trials Administrator

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Compare Linvoseltamab Monotherapy and Linvoseltam…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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