RecruitingPHASE3INTERVENTIONAL

A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma

This research study is investigating a new medication called JNJ-79635322 for people with multiple myeloma. Multiple myeloma is a cancer that affects certain blood cells in the bone marrow. The study focuses on patients whose myeloma has come back after earlier treatments (relapsed) or hasn't responded to those treatments (refractory). We want to find out how well JNJ-79635322 works compared to another treatment, Teclistamab. The aim is to understand if this new treatment can be more effective in controlling the cancer. This is a Phase 3 study, meaning it's a later stage of research, usually involving more people, to confirm the safety and effectiveness of a new treatment before it might become widely available.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

400

Start

04 Feb 2026

Estimated completion

30 Sep 2031

Multiple Myeloma

What is this study about?

This study is about finding better ways to treat multiple myeloma, a type of cancer that starts in the plasma cells in your bone marrow. When you have multiple myeloma, your body makes too many abnormal plasma cells, which can cause problems in your bones and kidneys, and affect your immune system.

Doctors are always looking for new and more effective treatments, especially for people whose myeloma has not responded well to previous medications or has unfortunately returned. This particular study is comparing a new experimental treatment, JNJ-79635322, with a treatment that's already being used, Teclistamab. Both of these treatments are designed to target and kill myeloma cells.

The main goal is to see which of these treatments works better in shrinking or controlling the cancer. Finding effective new treatments is really important because it gives patients more options and hope for living longer and feeling better. By taking part, you could be helping to advance our understanding of multiple myeloma and potentially help future patients. Your safety and well-being will be carefully monitored throughout the study.

Key takeaways

This study is testing a new treatment (JNJ-79635322) for multiple myeloma.
It's for people whose myeloma has come back or not responded to prior treatments.
The new treatment is compared against an existing one (Teclistamab).
It's a Phase 3 study, aiming to confirm safety and effectiveness.
Your health will be closely monitored throughout the study.

Who may be eligible?

To join this study, you must have been diagnosed with multiple myeloma and your doctors must be able to measure your cancer. You also need to have tried at least three different types of anti-myeloma treatments in the past, including specific kinds of drugs called a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.

Crucially, your cancer must have either gotten worse or not responded well to your last treatment. You should not be receiving any other cancer treatments at the same time as this study. You also need to be reasonably fit and able to carry out daily activities.

There are some reasons why you might not be able to join. For example, if you have active hepatitis, or if your myeloma has spread to your brain or spinal cord. Also, if you’ve recently had or plan to have major surgery, or if you're allergic to parts of the study medications, you wouldn't be able to take part. Receiving certain vaccines close to the study start or during the study would also prevent participation.

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 I have multiple myeloma that has come back or isn't responding to treatment?
Have I already tried at least three different types of myeloma treatments (including specific ones like a PI, IMiD, and anti-CD38 antibody)?
Is my general health good enough to participate in a study?
Do I have any other serious health conditions that might prevent me from joining, like active hepatitis or myeloma in my spine/brain?
Am I willing to follow the study's schedule of visits and treatments?

Answer every question to see your result.

What does participation involve?

Taking part in this study means you would receive one of the study medications (JNJ-79635322 or Teclistamab). You would have regular visits to the hospital or clinic for blood tests, check-ups, and to see how you are responding to the treatment. These visits will help the doctors monitor your health and how the medication is affecting your myeloma. The length of time you'd be in the study can vary, but generally, participants continue until their cancer gets worse, they have bothersome side effects, or they choose to stop. There will be follow-up appointments even after you stop the study treatment to keep track of your health.

Potential risks and benefits

Potential benefits of joining could include getting access to a new experimental treatment that might be more effective for your multiple myeloma, or receiving an established treatment under close medical supervision. However, like all medicines, these treatments can have side effects, which can range from mild to serious. The study team will carefully monitor you for any side effects and manage them as best as possible. You are absolutely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (43)

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

USC Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States· Recruiting
University of Connecticut Health Center
Verified postcode
Farmington, United States· Recruiting
Yale Cancer Center
Verified postcode
New Haven, United States· Recruiting
Florida Cancer Specialists & Research Institute
Verified postcode
Fort Myers, United States· Recruiting
Moffit Cancer center
Verified postcode
Tampa, United States· Recruiting
Emory University
Verified postcode
Atlanta, United States· Recruiting
University of Iowa Hospital and Clinics
Verified postcode
Iowa City, United States· Recruiting
Mission Cancer Blood
Verified postcode
Waukee, United States· Recruiting
Norton Cancer Institute
Verified postcode
Louisville, United States· Recruiting
Mount Sinai Brooklyn
Verified postcode
Brooklyn, United States· Recruiting
Mount Sinai Chelsea
Verified postcode
New York, United States· Recruiting
Icahn School of Medicine at Mount Sinai
Verified postcode
New York, United States· Recruiting

Common questions

What is multiple myeloma?

Multiple myeloma is a cancer of plasma cells, a type of white blood cell found in the bone marrow.

What does 'relapsed or refractory' mean?

It means the cancer has returned after previous treatments or hasn't responded well to those treatments.

What is a Phase 3 study?

A Phase 3 study is a later stage of research that compares a new treatment with an existing one to confirm its safety and how well it works.

Will I know which treatment I'm getting?

In some studies, you might not know which specific treatment you're receiving (this is called 'blinding'), but the study team can explain this further.

What if I experience side effects?

The study team will closely monitor you and provide care to manage any side effects you might experience during the study.

How to find out more

Study Contact

participate-in-this-study1@its.jnj.com 844-434-4210 Official trial record

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