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RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Assess the Safety and Anti-Tumor Activity of REGN7945 in Combination With Linvoseltamab in Adult Participants With Relapsed/Refractory Multiple Myeloma

This study is looking at two new drugs, REGN7945 and linvoseltamab, for people with multiple myeloma that has returned or not responded to previous treatments. Linvoseltamab has been studied before, but this is the first time REGN7945 is being tested in humans. The main goal is to find out if combining these two drugs is safe and whether it works better at treating the myeloma compared to using linvoseltamab by itself. We also want to understand any side effects, how long the treatment benefits people, and how the drugs behave in the body. Ultimately, we hope to find new ways to improve the quality of life for people living with multiple myeloma.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Regeneron Pharmaceuticals
Enrolment target
186
Start
11 Dec 2024
Estimated completion
01 Nov 2035

What is this study about?

This research study is investigating new treatments for a type of blood cancer called multiple myeloma. Specifically, it's for people whose cancer has either come back after treatment (relapsed) or hasn't responded to previous treatments (refractory). We are looking at two experimental medications, REGN7945 and linvoseltamab. Think of experimental medications as drugs still being tested to see if they are safe and effective, and how they compare to existing treatments.

Linvoseltamab has already been studied to some extent on its own in people with advanced multiple myeloma. However, this is the very first time REGN7945 will be given to people. The main purpose of this study is to see what happens when we use REGN7945 together with linvoseltamab. We want to understand how safe this combination is, whether people can tolerate it well, and how effective it is at fighting the multiple myeloma, compared to using linvoseltamab alone.

Beyond safety and how well the treatment works, we're also interested in several other important questions. This includes understanding any potential side effects, how long the treatment might benefit individuals, and how the drugs move through and are processed by the body. We'll also be checking if the body creates antibodies against these drugs, which could make them less effective. Importantly, the study will also look at whether these treatments can help improve symptoms like pain, how well people can carry out daily activities, and their overall quality of life.

Key takeaways

  • This study is testing two new, unapproved drugs for multiple myeloma.
  • It aims to see if combining them is safer and more effective than one drug alone.
  • It's for people whose myeloma has returned or not responded to previous treatments.
  • Participation involves close medical monitoring and receiving experimental treatment.
  • The study also looks at side effects, quality of life, and how the drugs work in the body.

Who may be eligible?

To join this study, people generally need to be 18 years or older. You would typically have been diagnosed with multiple myeloma and have tried at least three different types of treatment in the past, including specific kinds of drugs (like one called an anti-CD38 antibody, an IMiD, and a proteasome inhibitor). Importantly, your cancer must have started growing again after your last treatment.

You would also need to be generally well enough to take part, meaning you can mostly go about your daily activities without much help, and your body's systems like your blood, liver, and kidneys need to be working reasonably well. Doctors will check to make sure your myeloma can be measured, so we can see if the treatment is working.

There are also some reasons why you might not be able to join. For example, if you have certain other specific blood conditions (like plasma cell leukaemia), if you've had certain types of transplants recently, or if you're taking high doses of steroids. People with certain severe brain or nerve conditions, or who have recently had certain vaccinations, might also not be able to participate. Your medical team will carefully review all these details to see if this study is right 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.

  1. Are you 18 years old or older?
  2. Has your multiple myeloma come back or not responded to other treatments?
  3. Have you had at least three different types of treatment for your myeloma already?
  4. Are you generally well enough to go about your daily activities?
  5. Have you been free from certain brain or nerve conditions, or recent transplants?
Answer every question to see your result.

What does participation involve?

Unfortunately, the detailed plan for what taking part involves (like the number of visits, specific tests, or how long the total study lasts) wasn't provided in the information shared. However, in most clinical trials like this one, you can expect:

* **Regular Hospital Visits:** You would likely have frequent visits to the hospital or clinic, especially at the start of the study, for examinations, blood tests, and to receive the study medication. * **Study Medication:** You will receive either the combination of REGN7945 and linvoseltamab or linvoseltamab on its own, based on what the study design indicates. These are typically given intravenously (through a drip). * **Side Effect Monitoring:** The study team will closely monitor you for any side effects and how you are feeling generally. * **Tests and Scans:** Expect to have regular blood tests, scans (like CT or MRI), and other checks to see how your multiple myeloma is responding to the treatment and to keep an eye on your overall health. * **Questionnaires:** You might be asked to complete questionnaires about your symptoms and quality of life. * **Follow-up:** Even after you stop receiving the study medication, there will usually be a follow-up period to continue monitoring your health and the long-term effects of the treatment.

Before you agree to participate, the study team would explain everything in much more detail, including the exact schedule and what's expected of you, so you know exactly what is involved.

Potential risks and benefits

There are some potential benefits to taking part in this study. You would receive regular medical care and close monitoring, and you might be among the first to access a new treatment that could potentially help manage your multiple myeloma more effectively than standard therapies. However, there are also risks. Because these are experimental drugs, there's a chance of unexpected side effects, and the treatment might not work for everyone. The study treatments could also cause side effects that are more serious than those of current treatments, or they might not help at all. You are free to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Illawarra Cancer Care Centre
    Verified postcode
    Wollongong, Australia· Recruiting
  • Pindara Private Hospital
    Verified postcode
    Benowa, Australia· Recruiting
  • Royal Adelaide Hospital
    Verified postcode
    Adelaide, Australia· Recruiting
  • Alfred Hospital
    Verified postcode
    Melbourne, Australia· Recruiting
  • St Vincents Hospital Melbourne
    Verified postcode
    Melbourne, Australia· Recruiting
  • University College London Hospitals
    Verified postcode
    London, United Kingdom· Recruiting
  • The Christie NHS Foundation Trust
    Verified postcode
    Manchester, United Kingdom· Recruiting

Common questions

What is multiple myeloma?

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

Are the study drugs already approved?

No, REGN7945 and linvoseltamab are experimental drugs, meaning they are still being tested and are not yet approved for general use.

Will I know if I'm getting one or both drugs?

The study design will determine this. In some studies, participants are randomly assigned to a group, and you might not know which specific treatment you are receiving until after the study ends.

What does 'relapsed/refractory' mean?

It means your multiple myeloma has either come back after previous treatment (relapsed) or it hasn't responded to earlier treatments (refractory).

Who is running this study?

This study is being sponsored by a pharmaceutical company called Regeneron Pharmaceuticals, Inc.

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 Assess the Safety and Anti-Tumor Activity of REGN…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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