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RecruitingPHASE3INTERVENTIONAL

Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma

This study is inviting adults who have multiple myeloma, a cancer affecting blood cells, that has either returned after treatment or hasn't improved with current medicines. We want to see how a new experimental drug called etentamig compares to standard treatments already available. Participants will be put into two groups: one receiving etentamig given directly into a vein, and the other receiving a standard treatment chosen by their doctor. The study will last about 3.5 years, and doctors will regularly check how well the treatments are working, monitor for side effects, and assess changes in symptoms. The aim is to find out if etentamig can help manage the disease better.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
AbbVie
Enrolment target
380
Start
19 May 2024
Estimated completion
01 Dec 2027

What is this study about?

Multiple myeloma is a type of cancer that affects specific cells in your blood, called plasma cells. These cells are mostly found in your bones and the soft, spongy tissue inside your bones called bone marrow. This cancer can cause problems like bone pain, weaker bones, fractures, infections, and even kidney issues. While there are treatments available for multiple myeloma, sometimes the cancer can return after treatment (this is called 'relapsed'), or it might not get better with the treatments you've tried (this is called 'refractory').

This study is looking at a new medicine called etentamig. It's an experimental drug, meaning it's still being tested to see if it's safe and effective for treating multiple myeloma that has come back or isn't responding to other treatments. The study aims to compare etentamig with treatments already used for multiple myeloma to see which works best to control the disease and improve symptoms.

About 380 adult patients from hospitals and clinics worldwide will take part. Participants will be divided into two groups. One group will receive etentamig, given as a drip into a vein. The other group will receive what's called 'standard available therapy' – this is a treatment that your doctor would normally recommend based on approved guidelines and your specific situation. This helps researchers understand how etentamig compares to what doctors currently use.

Key takeaways

  • This study evaluates an experimental drug, etentamig, for advanced multiple myeloma.
  • It compares etentamig against established standard treatments.
  • Participants will be adults whose multiple myeloma has returned or not responded to previous therapies.
  • The study involves regular hospital visits over roughly 3.5 years for treatment and check-ups.
  • You might receive the new drug or a standard treatment; it's decided for you.
  • Close monitoring for side effects and disease progress is a key part of participating.

Who may be eligible?

This study is for adults aged 18 and over who have multiple myeloma that has either come back or isn't responding to previous treatments.

To be considered, your overall health should be reasonably good, and doctors need to be able to measure your cancer to see how well treatments are working. You must also have received at least two past treatments for multiple myeloma, including specific types of medication. However, if you're in the US or Puerto Rico, you only need to have had one past treatment that included these specific types of medication. You also need to be a suitable candidate for one of the standard treatments used in this study.

You cannot join if you have certain other serious health problems, a history of drug or alcohol misuse recently, or if your multiple myeloma has spread to your brain or spinal cord. If you've had a specific type of treatment called BCMA-targeted therapy, you also won't be able to join this study.

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 past treatments?
  3. Have you had at least two lines of treatment for your myeloma (or one line if in the US/Puerto Rico)?
  4. Is your general health good enough for you to participate?
  5. Have you *not* had a specific type of treatment called BCMA-targeted therapy?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be involved for about three and a half years. During this time, you will have regular visits to your hospital or clinic. At these visits, you will receive your assigned study medication – either etentamig or a standard treatment – as a drip into a vein. This will happen in 28-day cycles.

Throughout the study, the medical team will carry out regular checks to see how you're responding. This will involve medical assessments, blood tests, carefully watching for any side effects, and asking you to complete questionnaires about how you're feeling. There might be more hospital visits and tests involved in this study compared to your usual care, but the team will guide you through everything.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. While there's no guarantee, you might benefit from receiving a new, potentially effective treatment (etentamig) or from receiving very closely monitored standard care. However, experimental treatments can have side effects that aren't fully known yet. You will be closely monitored for any reactions or side effects. Always remember, joining this study is completely your choice, and you have the right to leave the study at any time, for any reason, without it affecting your future medical care.

Locations (166)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Alabama at Birmingham - Main /ID# 261434
    Verified postcode
    Birmingham, United States· Recruiting
  • Mayo Clinic Hospital - Phoenix /ID# 263326
    Verified postcode
    Phoenix, United States· Recruiting
  • Alta Bates Summit Medical Center for Research /ID# 261438
    Verified postcode
    Berkeley, United States· Completed
  • Providence - St. Jude Medical Center /ID# 262031
    Verified postcode
    Fullerton, United States· Recruiting
  • VA Loma Linda Healthcare System /ID# 261015
    Verified postcode
    Loma Linda, United States· Recruiting
  • Cedars-Sinai Medical Center /ID# 261008
    Verified postcode
    Los Angeles, United States· Recruiting
  • Rocky Mountain Cancer Centers - Lone Tree /ID# 278320
    Verified postcode
    Lone Tree, United States· Recruiting
  • Mayo Clinic Hospital Jacksonville /ID# 263324
    Verified postcode
    Jacksonville, United States· Recruiting
  • Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 246230
    Verified postcode
    Jacksonville, United States· Recruiting
  • Winship Cancer Institute of Emory University /ID# 262525
    Verified postcode
    Atlanta, United States· Recruiting
  • University of Illinois Hospital and Health Sciences System /ID# 246349
    Verified postcode
    Chicago, United States· Recruiting
  • Rush University Medical Center /ID# 265690
    Verified postcode
    Chicago, United States· Completed

Common questions

What is multiple myeloma?

It's a cancer of plasma cells, a type of blood cell, usually found in your bones and bone marrow.

What does 'relapsed or refractory' mean?

It means the cancer has come back after treatment, or it hasn't responded well to previous treatments.

What is etentamig?

Etentamig is a new, experimental drug being tested to see if it can help treat multiple myeloma.

How long will the study last?

The study will last for about three and a half years.

Will I definitely get the new drug, etentamig?

No, you will be in one of two groups: one gets etentamig, and the other gets a standard treatment chosen by your doctor.

How to find out more

ABBVIE CALL CENTER

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 "Study Assessing Activity of Intravenous (IV) Etentamig Monot…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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