RecruitingPHASE1INTERVENTIONAL

A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma

This study is investigating a new medication called etentamig (ABBV-383) for adults with multiple myeloma. This is a type of blood cancer that affects bones and can cause pain, fractures, and kidney problems. Sometimes, standard treatments don't work or the cancer comes back. This study aims to understand the side effects of etentamig and how it changes the disease symptoms. Patients will receive the medicine through a drip in their vein over about three years, with regular hospital checks. The study also explores different ways to give the medicine and how much to give, including whether it can be given as an outpatient.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

AbbVie

Enrolment target

210

Start

21 Mar 2023

Estimated completion

01 Aug 2029

Multiple Myeloma

What is this study about?

Multiple myeloma is a type of cancer that starts in certain blood cells found in your bones. It can lead to problems like bone pain, fractures, and kidney issues. While there are treatments, sometimes the cancer can return after treatment (called 'relapsed') or doesn't get better with treatment (called 'refractory'). When this happens, doctors look for new ways to help patients.

This study is testing an investigational medicine named etentamig (ABBV-383). It's called 'investigational' because it's still being studied and isn't available as a standard treatment yet. The main goal of this study is to learn more about the possible side effects of etentamig and how it might affect the symptoms of multiple myeloma in adults whose cancer has relapsed or become refractory. It's important to understand if new medicines are safe and if they can help patients.

The study involves different groups of participants to test various aspects of the medicine. For example, some groups will help determine the best dose of etentamig, starting with small amounts and slowly increasing. Other groups will look at whether the medicine can be given outside of the hospital as an outpatient. Around 210 adults with relapsed or refractory multiple myeloma from different locations around the world will take part in this research.

Key takeaways

This study is for adults with multiple myeloma that has come back or isn't responding to standard treatments.
It's testing a new medicine called etentamig (ABBV-383) given as a drip into a vein.
The main goals are to find out about side effects and how the medicine affects the disease.
Participation involves regular hospital visits for medical checks, blood tests, and side effect monitoring.
The treatment could last for about three years.
Different groups will test various doses and ways to give the medicine, including as an outpatient.

Who may be eligible?

To join this study, participants generally need to have multiple myeloma that has either come back or isn't getting better after previous treatments. Their general health and ability to perform daily activities would be carefully assessed by the study doctors. They must not have received this specific study drug, etentamig (ABBV-383), before.

Depending on which part of the study a person might join, there are different requirements regarding their previous treatments. For example, some parts of the study are for people who have had at least two or three different types of treatment in the past, including specific kinds of medicines for multiple myeloma. Other parts might consider fewer previous treatments if the person is suitable for receiving the study drug at home or as an outpatient.

People would generally not be able to join if their disease is getting worse very quickly, or if they have had other specific types of therapies targeting a certain protein called BCMA.

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.

Do you have multiple myeloma that has returned or isn't responding to treatment?
Have you had at least 2 or 3 previous treatments for your multiple myeloma?
Are you generally well enough to participate in a study, as assessed by a doctor?
Have you NOT received the specific study drug, etentamig (ABBV-383), before?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will receive the investigational medicine, etentamig (ABBV-383), through a drip into your vein (an IV infusion). This treatment will be given in cycles lasting 28 days each, and you could be receiving it for up to approximately three years.

Throughout the study, you will have regular visits to a hospital or clinic. During these visits, the study team will carry out several checks. This includes medical examinations, blood tests to see how you're responding and to monitor for any changes, and checks for any side effects you might experience. You may also be asked to fill out questionnaires about how you are feeling. These regular checks are vital for the study team to understand how the medicine is working and to ensure your safety.

Potential risks and benefits

Taking part in a research study might offer the potential benefit of accessing an investigational medicine that is not yet widely available for your condition. However, there's no guarantee the medicine will work, and like all medicines, etentamig may have side effects, some of which could be serious or unexpected. The study involves many hospital visits and tests, which can be time-consuming and may add to your treatment burden. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (44)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Mayo Clinic Arizona /ID# 251405
Verified postcode
Phoenix, United States· Recruiting
Highlands Oncology Group - Springdale /ID# 267742
Verified postcode
Springdale, United States· Recruiting
Rocky Mountain Cancer Centers - Aurora /ID# 268574
Verified postcode
Aurora, United States· Recruiting
Medical Oncology Hematology Consultants /ID# 268560
Verified postcode
Newark, United States· Recruiting
Hope And Healing Cancer Services /ID# 268536
Verified postcode
Hinsdale, United States· Recruiting
Fort Wayne Medical Oncology And Hematology /ID# 268179
Verified postcode
Fort Wayne, United States· Recruiting
Tulane University School of Medicine /ID# 251204
Verified postcode
New Orleans, United States· Recruiting
Maryland Oncology Hematology - Silver Spring /ID# 268562
Verified postcode
Silver Spring, United States· Not yet recruiting
Mayo Clinic - Rochester /ID# 251164
Verified postcode
Rochester, United States· Recruiting
NHO Revive Research Institute, LLC /ID# 267869
Verified postcode
Lincoln, United States· Recruiting
Mt Sinai /ID# 251166
Verified postcode
New York, United States· Recruiting
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167
Verified postcode
New York, United States· Recruiting

Common questions

What is multiple myeloma?

It's a type of cancer that affects plasma cells, a kind of blood cell, and often causes problems in the bones and bone marrow.

What does 'relapsed or refractory' mean?

It means the cancer has come back after treatment (relapsed) or hasn't responded to previous treatments (refractory).

What is etentamig (ABBV-383)?

It's a new medicine being tested in this study for treating multiple myeloma.

How will I receive the medicine?

It will be given as a drip into your vein (IV infusion) in cycles that last 28 days.

How long will the study last?

Participants will receive the medicine for around three years, with regular check-ups during that time.

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.