RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion Alone or in Combination With Oral, IV, Subcutaneous Daratumumab; Lenalidomide; Dexamethasone; Carfilzomib

This research study is looking for adults with multiple myeloma, a cancer of the blood that affects bone marrow. We want to test a new drug called Etentamig. We'll be looking at how safe it is and how well it works, either on its own or when combined with other medicines you might already be familiar with, such as Daratumumab, Lenalidomide, Dexamethasone, or Carfilzomib. Multiple myeloma can sometimes come back or stop responding to treatment. This study aims to find new and better ways to control the disease. It will involve regular visits to a hospital or clinic and different tests to monitor your health and the treatment's effect.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

AbbVie

Enrolment target

440

Start

30 Jun 2025

Estimated completion

01 Mar 2036

Multiple Myeloma

What is this study about?

Multiple myeloma is a type of cancer that starts in certain white blood cells called plasma cells, which are found in your bone marrow (the soft, spongy material inside your bones). This cancer can cause problems like bone pain, weaker bones, and kidney issues. While there are treatments available, sometimes the cancer can return or stop responding to current medicines.

This study is designed to explore a new potential treatment called Etentamig (also known as ABBV-383). Researchers want to find out if Etentamig can help manage multiple myeloma. They will look at how safe it is and how well it works, both when given on its own and when combined with other medications often used for multiple myeloma. These include drugs like Daratumumab, Lenalidomide, Dexamethasone, and Carfilzomib.

The study is split into different parts. Some people will receive Etentamig alone, while others will get it alongside one or more of the other listed medications. Gradually, the researchers will increase the dose of Etentamig to find the safest and most effective amount. They will then test these promising doses further. The aim is to find better treatment options for people living with multiple myeloma.

Key takeaways

This study tests a new drug, Etentamig, for multiple myeloma.
It aims to find safer and more effective ways to treat the cancer.
You might receive Etentamig alone or with other standard treatments.
Participation involves regular hospital visits and health checks.
The study includes various stages to find the right doses.

Who may be eligible?

To join this study, adult patients must have a confirmed diagnosis of multiple myeloma. This includes people who have just been diagnosed or whose cancer has returned or stopped responding to previous treatments, depending on the specific part of the study.

There are also some conditions that would prevent someone from joining. For example, if your multiple myeloma has spread to your brain or spinal cord, or if you currently have an active infection that is outlined in the study's rules, this study might not be suitable for you.

Quick self-check

Are you an adult aged 18 or over?
Do you have a confirmed diagnosis of multiple myeloma?
Is your general health good enough for you to be up and about most days (as determined by a doctor)?
Have you been told your multiple myeloma hasn't spread to your brain or spinal cord?
Do you currently not have any serious active infections?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will have regular visits to a hospital or clinic over a long period, potentially several years. During these visits, you will receive the study medication (Etentamig) through a drip into your vein. Depending on which group you're in, you might also take other medicines by mouth, injection, or drip.

Throughout the study, the medical team will carry out various checks to see how you are doing. This includes medical checks, blood tests, and looking for any side effects. You might also be asked to complete questionnaires about your health. The total duration of the study for all participants could be around 130 months, which is over 10 years, though your individual participation might be shorter.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments before they are widely available, which could potentially benefit your health. However, as Etentamig is an investigational drug, there might be unknown side effects or the treatment might not work as expected. The study also involves more hospital visits and tests than standard care, which can be time-consuming. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (25)

Colorado Blood Cancer Institute /ID# 273129
Denver, United States· Recruiting
Moffitt Cancer Center /ID# 272628
Tampa, United States· Recruiting
Winship Cancer Institute of Emory University /ID# 274830
Atlanta, United States· Recruiting
Weill Cornell Medical College /ID# 272517
New York, United States· Recruiting
University of North Carolina at Chapel Hill /ID# 274667
Chapel Hill, United States· Recruiting
Atrium Health Levine Cancer Institute /ID# 276193
Charlotte, United States· Recruiting
Atrium Health Wake Forest Baptist Medical Center /ID# 274847
Winston-Salem, United States· Recruiting
Oncology Hematology Care - Kenwood /ID# 272918
Cincinnati, United States· Recruiting
Coffs Harbour Health Campus /ID# 272010
Coffs Harbour, Australia· Recruiting
Port Macquarie Base Hospital /ID# 275925
Port Macquarie, Australia· Recruiting
Westmead Hospital /ID# 271880
Westmead, Australia· Recruiting
Icon Cancer Care - South Brisbane /ID# 271836
South Brisbane, Australia· Recruiting

+13 more sites — see the official record for the full list.

Common questions

What is multiple myeloma?

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

What is Etentamig?

It's a new drug being tested to see if it can help treat multiple myeloma.

Will I get Etentamig alone or with other drugs?

That depends on which part of the study you are in. You might get it alone or in combination with other common multiple myeloma medicines.

How long will the study last?

The study itself is expected to last a long time, around 10 years. Your personal involvement might be shorter.

Are there more hospital visits with this study?

Yes, taking part in this study will likely mean more frequent hospital or clinic visits compared to standard care.

How to find out more

ABBVIE CALL CENTER

abbvieclinicaltrials@abbvie.com 844-663-3742 Official trial record

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