Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma

This study is for adults aged 18 and over in the UK who have multiple myeloma, a type of blood cancer. This means their multiple myeloma has either returned after treatment or hasn't responded to previous treatments. The new medicine being tested is called Forimtamig. Because this is a very early-stage study, the main goal is to find out if different doses of Forimtamig are safe for people to take. Researchers will also learn how the medicine behaves in the body, such as how long it stays in the system and how it's processed. This information is crucial for understanding how to use the medicine effectively and safely in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

180

Start

15 Mar 2024

Relapsed or Refractory Multiple Myeloma

What is this study about?

This research study is about a new medicine called Forimtamig designed to help people living with multiple myeloma. Multiple myeloma is a type of cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. Sometimes, even after treatment, multiple myeloma can return (this is called 'relapsed') or it might not get better with current treatments (this is called 'refractory'). This study focuses on people in the UK who are in these situations.

The main purpose of this study is to carefully test Forimtamig. Because it's a very early-stage study, often called a Phase I study, the researchers are particularly interested in two main things. Firstly, they want to make sure the medicine is safe for people to take. They will start with small doses and gradually increase them to find a dose that is both safe and has the potential to be effective.

Secondly, the researchers want to understand how Forimtamig works inside the body. This includes how it's absorbed, how it's distributed, how it's broken down, and how it leaves the body. This information, often called 'pharmacokinetics', is really important because it helps doctors decide on the best dose and how often the medicine should be given in future studies.

Key takeaways

This study is testing a new medicine called Forimtamig for multiple myeloma.
It's for people whose multiple myeloma has returned or not responded to past treatments.
The main aim is to check the medicine's safety and how it works in the body.
Participants must be 18 years old or older.
Taking part means regular check-ups and monitoring by a medical team.

Who may be eligible?

This study is looking for adults who are 18 years old or older. You could be a man or a woman to join.

The most important thing is that you must have multiple myeloma that has either come back after you’ve had treatment for it, or it hasn’t responded well to treatments you’ve already tried. This is often called 'relapsed or refractory' multiple myeloma.

There might be other health conditions or medications that mean you can't join the study, even if your multiple myeloma fits. The study doctor will check all these details with you carefully to make sure it's safe for you to take part.

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?
Or has your multiple myeloma not responded well to previous treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given the new medicine, Forimtamig. You will have regular appointments where the study team will take blood samples, do physical check-ups, and ask you about how you are feeling and any side effects you might be having. These checks are important to see how the medicine is affecting your body and to make sure you are safe. The study will involve several visits to the clinic, especially in the beginning, and then potentially fewer visits later on. The total length of your participation will depend on how you respond to the treatment and the study plan, but the doctor will explain the expected duration to you.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might receive a new treatment for your multiple myeloma that isn't available outside of the study, which could help your condition; however, this isn't guaranteed. Potential risks include experiencing side effects from the new medicine, or that it might not work for you. The medical team will monitor you closely for any problems. Remember, you have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Spain
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Unverified
Italy
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Unverified
Denmark
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Unverified
France
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Unverified
Belgium

Common questions

What is multiple myeloma?

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

What does 'relapsed or refractory' mean?

It means your multiple myeloma has either returned after you've had treatment, or it hasn't responded well to treatments you've tried before.

What is Forimtamig?

Forimtamig is a new medicine being tested in this study for people with multiple myeloma.

Will I definitely get the new medicine?

Yes, in this type of study, all participants who are eligible will receive the study medicine, Forimtamig.

What is a Phase 1 study?

A Phase 1 study is an early-stage study that mainly checks if a new medicine is safe and how it works in the body, rather than how effective it is.