Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase 1 Study of JNJ-87562761 in Relapsed/Refractory Multiple Myeloma

This is an early-stage research study, often called a Phase 1 trial, for an experimental medicine named JNJ-87562761. It's designed for adults in the UK who have multiple myeloma, a type of blood cancer, that has either returned after treatment or hasn't improved with other medicines. The main goal of this particular study is to see how safe the new medicine is, how the body handles it, and if there are any immediate side effects, since this is the very first time it's being tested in people. This type of trial helps doctors understand if a new treatment might be helpful in the future and how to best give it to patients.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Janssen Cilag International

Enrolment target

Start

11 Oct 2024

Relapsed/Refractory Multiple Myeloma

What is this study about?

This research is focused on a type of blood cancer called multiple myeloma. In multiple myeloma, certain cells in the bone marrow grow out of control. Sometimes, despite receiving treatments, the cancer can return (this is called 'relapsed') or it might not respond well to existing medicines (this is called 'refractory'). When this happens, doctors are always looking for new and different ways to fight the cancer.

That's where this study comes in. It's investigating a new medicine called JNJ-87562761. This is a very early stage trial, often known as a 'Phase 1' study. In Phase 1 studies, the new medicine is given to people for the very first time. The main purpose at this stage is not to cure the cancer, but rather to carefully check how safe the medicine is, what happens when it's given to people, and if there are any side effects. Researchers will also be looking to see if it shows any early signs of helping with the disease.

By taking part, you would be helping doctors and scientists learn more about this potential new treatment. This information is very important for deciding if JNJ-87562761 should be studied further in larger groups of people, and ultimately, whether it could become a new treatment option for multiple myeloma in the future.

Key takeaways

This is an early-stage (Phase 1) study for a new medicine.
It's for adults with multiple myeloma that has returned or is hard to treat.
The main focus is to check the medicine's safety for the first time in humans.
Participants will have regular health checks and doctor visits.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is particularly looking for adults aged 18 or older who have multiple myeloma.

To be considered, your multiple myeloma must be in a 'relapsed' or 'refractory' state. This means your cancer has either returned after you've already had treatment for it, or it hasn't responded as expected to previous treatments you've received. Both men and women can potentially join this study.

There will be other, more detailed health requirements that the study doctors will discuss with you. These are in place to help make sure the study medicine is as safe as possible for everyone taking part and to ensure the results of the study are clear.

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?
Have you been diagnosed with multiple myeloma?
Has your multiple myeloma come back after treatment?
Has your multiple myeloma not responded to past treatments?
Are you able to attend regular hospital/clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a number of tests and checks to make sure your health meets the study's requirements. If you are eligible, you would start receiving the study medicine, JNJ-87562761. This medicine would be given to you in a specific way and at certain times, as determined by the study plan.

You would need to attend regular visits to the hospital or clinic. During these visits, the study team would carefully monitor your health. This would involve repeat blood tests, physical examinations, and other checks to see how your body is responding to the medicine and to look out for any side effects. You would be asked to report how you are feeling and any new symptoms you experience. The total duration of your participation, including follow-up after receiving the medicine, would be explained to you by the study team.

Potential risks and benefits

As with any research study involving a new medicine, there are potential benefits and potential risks to consider. A potential benefit is that the new medicine, for some people, might help control their multiple myeloma, even if it's an early-stage study. However, because this is the first time the medicine is being given to humans, there might be unknown side effects or the medicine might not work for you. The study team will explain all known or expected risks. You should know that taking part in any clinical trial is always completely voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What does 'Relapsed/Refractory Multiple Myeloma' mean?

It means your multiple myeloma has either come back after treatment or hasn't responded well to previous treatments.

What is a Phase 1 study?

It's the very first stage where a new medicine is given to humans to check its safety and how the body handles it.

Will this medicine cure my cancer?

In this early stage, the main goal is to check safety. While it might help, cure is not the primary aim of a Phase 1 study.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.

What is JNJ-87562761?

It's the experimental new medicine being tested in this study for multiple myeloma.