RecruitingPhase IIIInterventional

A study comparing JNJ-79635322 and an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody in participants with relapsed or refractory multiple myeloma (Trilogy-4)

This study is called Trilogy-4 and is for people aged 18 and older in the UK with multiple myeloma, a type of blood cancer, that has either returned after treatment (relapsed) or isn't responding to treatment (refractory). We are testing a new medicine, JNJ-79635322, given as an injection under the skin. This new medicine aims to help your body's immune cells fight the cancer cells. We will compare it to an existing approved medicine called teclistamab, also given as an injection. Participants will be randomly assigned to receive one of these two treatments. The main goal is to see if JNJ-79635322 is an effective treatment. The study involves regular check-ups and monitoring over about five years.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Janssen-Cilag International NV

Enrolment target

Start

03 Mar 2026

Estimated completion

14 Jun 2027

Relapsed or refractory multiple myeloma

What is this study about?

You're looking at information about a clinical trial called Trilogy-4. This study is for people who have multiple myeloma, which is a cancer that affects certain cells in your bone marrow. This type of cancer is called 'relapsed' if it has come back after treatment, or 'refractory' if it hasn't responded to previous treatments. If you have been living with multiple myeloma for a while and have tried several other treatments, this study might be for you.

The main aim of this study is to test a new medicine called JNJ-79635322. This medicine is given as an injection under the skin. It's designed to help your own immune system fight the cancer cells by targeting specific proteins on the cancer cells and activating your T-cells, which are a type of immune cell. We want to see how well it works compared to an already approved medicine, teclistamab, which also works in a similar way to help your immune system.

Taking part in this study means you would be contributing to scientific knowledge that could help future patients with multiple myeloma. Even though this new medicine is still being researched, studies like this are essential to find better ways to treat serious conditions. The study will last for about five years, including initial checks, treatment, and follow-up appointments to monitor your health.

Key takeaways

This study is for adults with multiple myeloma that has come back or isn't responding to treatment.
It compares a new experimental medicine (JNJ-79635322) with an approved medicine (teclistamab).
Both medicines are given as injections under the skin.
You must have tried at least three different types of cancer therapies before joining.
The study involves regular health checks and could last around five years.
There are potential risks and benefits, and you can withdraw at any time.

Who may be eligible?

To be able to join this study, you need to be at least 18 years old. You must have been diagnosed with multiple myeloma and it needs to be either back after treatment or not responding to treatment. Importantly, you should have already received at least three different types of cancer treatments, including specific kinds of drugs called a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and a drug that targets CD38.

Your cancer must show signs of activity that can be measured, either in your blood or urine. Also, any side effects you might have had from your previous cancer treatments should have mostly cleared up and be mild (Grade 1) or better, though things like hair loss or skin changes are usually fine.

This study is open to everyone, regardless of gender. If you meet these main points, the study team will be able to check more detailed requirements to see if this study is suitable 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.

Are you 18 years old or older?
Do you have multiple myeloma that is relapsed or refractory?
Have you already had at least three different types of myeloma treatments, including a PI, an IMiD, and a CD38-targeting drug?
Are your previous treatment side effects mostly gone or mild?
Can your myeloma be measured in blood or urine tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve a few stages. First, there's a 'screening' phase, which lasts up to 28 days. During this time, doctors will do checks to make sure the study is right for you. If you qualify, you'll then enter the 'treatment' phase.

In the treatment phase, you'll be put into one of two groups by chance, like flipping a coin. One group will receive the new medicine, JNJ-79635322, as an injection under the skin. The other group will receive teclistamab, also as an injection under the skin. You won't get both. Throughout this phase, you'll have regular appointments for physical exams, checks of your vital signs (like blood pressure), and blood tests to monitor your health and see how the treatment is working. Any side effects will be carefully recorded. After your treatment period, there's a 'follow-up' phase where doctors will continue to monitor your health. The entire study is expected to last around five years.

Potential risks and benefits

There isn't a guaranteed benefit for you from taking part in this study, especially because JNJ-79635322 is a new medicine and we don't know for sure if it will work. However, some people might feel better simply from having regular health checks. Your participation could also help doctors learn more about multiple myeloma and lead to new treatments that can help others in the future. Like all medicines and medical procedures, there are potential risks. You might experience side effects from the study drugs or tests. These can range from mild to severe, or even life-threatening. Common side effects include inflammation, neurological issues like headaches, infections, low protein levels, skin and nail problems, or reactions where the injection was given. Not all possible risks are known yet, but your study doctor will keep you informed of any new information. You are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Kent and Canterbury Hospital
Approximate
Canterbury, England
Royal Marsden Hospital
Approximate
Sutton, England
Queen Alexandra Hospital
Approximate
Portsmouth, England
University Hospital of Wales
City only
Cardiff, England
Ninewells Hospital
Approximate
Dundee, Scotland
University College London Hospitals NHS Foundation Trust
City only
London, England
Nottingham City Hospital
City only
Nottingham, England

Common questions

What is multiple myeloma?

Multiple myeloma is a type of blood cancer that affects white blood cells called plasma cells, found in your bone marrow.

What does 'relapsed or refractory' mean?

Relapsed means your cancer has come back after treatment. Refractory means your cancer hasn't responded to previous treatments.

What is JNJ-79635322?

JNJ-79635322 is a new, investigational medicine given by injection under the skin, designed to help your immune system fight cancer cells.

How long will the study last?

The study, including screening, treatment, and follow-up, is expected to last for about five years.

Will I have to pay to be in the study?

No, there are no costs for participants. The study drug and tests are paid for, and you may get help with travel costs.

How to find out more

Lacramioara Arvatu

JanssenUKRegistryQueries@its.jnj.com - Official trial record

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