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

A Trial to Determine the Safety of CC-93269, an Antibody, in People who have Multiple Myeloma That Has Returned After a Period of Treatment And is not Responsive After Treatment.

This research study is about a new medicine, an antibody called CC-93269, for people who have multiple myeloma. This is a type of cancer that affects a certain kind of white blood cell. Doctors are particularly interested in patients whose myeloma has returned after they've had treatment, and whose cancer isn't getting better with the treatments they are currently receiving. This is a very early-stage study, called Phase I. This means it's one of the first times this new medicine is being given to people. The most important thing the doctors want to find out in this study is if CC-93269 is safe for people to take, and what effects it might have on the body. It's a key first step in understanding if this medicine could help patients in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Celgene International II S.a.r.l.

Enrolment target

112

Start

06 Oct 2023

Relapsed and refractory multiple myeloma (RRMM)

What is this study about?

This study is testing a new experimental medicine called CC-93269. This medicine is a type of antibody, which is a protein designed to find and attach to specific targets in the body, similar to how your immune system fights off infections. In this case, CC-93269 is being explored as a potential treatment for multiple myeloma.

Multiple myeloma is a type of cancer that starts in the bone marrow, affecting cells called plasma cells. These are important for your immune system. The study is specifically for people whose multiple myeloma has returned after they've already had treatment, and for whom those treatments are no longer working. Doctors call this 'relapsed and refractory' multiple myeloma.

This is a "Phase I" study. This means it's one of the first times this specific medicine is being given to people. The main purpose of a Phase I study is to carefully check if the new medicine is safe, find out what dose might be best, and see how the body handles it. It's an important early step to see if this medicine has the potential to help patients with multiple myeloma in the future.

Key takeaways

This study is testing a brand new medicine for multiple myeloma.
It's for people whose cancer has returned and isn't responding to current treatments.
The main goal is to find out if the new medicine, CC-93269, is safe.
This is an early-stage study (Phase I).
It's an important step in developing new potential treatments.

Who may be eligible?

To join this study, you must be an adult aged 18 or over. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.

Crucially, you would be considered for this study if you have multiple myeloma that has come back after you've already had treatment, and if your current treatments are not helping to control the cancer. This means your doctors have tried various treatments, but the cancer is still active.

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 previous treatments?
Are your current treatments no longer working well for your multiple myeloma?

Answer every question to see your result.

What does participation involve?

Details about what taking part in this study involves aren't fully described in the brief summary provided. However, in a typical Phase I study like this, you would likely have regular visits to the clinic for medical check-ups, blood tests, and other assessments to monitor your health and how your body is responding to the new medicine. You would receive the study medication, CC-93269, according to a schedule set by the researchers. The total duration of your participation, including follow-up appointments after you stop taking the study medicine, would be explained to you in detail by the study team.

Potential risks and benefits

Taking part in any medical research comes with potential benefits and risks. A potential benefit of joining this study could be access to a new treatment (CC-93269) that is not yet widely available, which might help your multiple myeloma when other treatments haven't worked. However, there are also potential risks, as this is a new medicine, and doctors are still learning about its side effects. These side effects could be mild or serious. You will be closely monitored for any unwanted effects. Importantly, you are always free to decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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
Germany
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Unverified
Sweden
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Unverified
Italy

Common questions

What is multiple myeloma?

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

What does 'relapsed and refractory' mean?

It means your multiple myeloma has returned after previous treatments, and those treatments are no longer working to control the cancer.

What is a 'Phase I' study?

It's the first stage of testing a new medicine in humans, mainly to find out if it's safe and what the right dose might be.

What is CC-93269?

It's a new experimental medicine, a type of antibody, being studied as a potential treatment for multiple myeloma.

Will I get better if I join this study?

Doctors don't know yet if this medicine will make people better, as this is a very early study focused on safety. It's a step towards finding future treatments.