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

A Phase 1, Dose Finding Study of CC-92328 in Subjects with Relapsed and/or Refractory Multiple Myeloma.

This research study is about a new drug called CC-92328 for people who have multiple myeloma. Multiple myeloma is a type of cancer that affects certain cells in your bone marrow. This study is specifically for patients whose multiple myeloma has returned after previous treatments, or hasn't got better with the treatments they've already tried. It's a very early-stage trial, which means it's one of the first times this new drug is being given to people. The main goal is to find a safe and effective dose of CC-92328, and to see what effects it has on the body. Understanding this will help doctors decide on the best way to use the drug in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Celgene Corp.

Enrolment target

Start

10 Jul 2023

Multiple myeloma

What is this study about?

This study is focused on people who have multiple myeloma. Multiple myeloma is a cancer of plasma cells, which are a type of white blood cell found in the bone marrow. These cells help fight infections, but in multiple myeloma, they grow out of control and can cause problems with bones, kidneys, and blood. If you've been diagnosed with multiple myeloma and your current treatments haven't worked or your cancer has come back, this study might be relevant to you.

The new medicine being tested in this study is called CC-92328. Scientists want to learn more about how this drug works in the human body. Because this is an early-stage study, it's one of the first times CC-92328 is being given to people. The main aim is to find the best and safest dose of the medicine. This is a crucial step in developing any new treatment, as it helps researchers understand how much medicine is needed to have an effect without causing too many unwanted side effects.

The information gathered from this study will help researchers decide if CC-92328 is promising enough to be tested in larger groups of people in the future. It's an important part of finding new ways to help people with multiple myeloma, especially those who haven't benefited from existing treatments.

Key takeaways

This study is testing a new drug, CC-92328, for multiple myeloma.
It's for people whose cancer has returned or didn't respond to other treatments.
The main aim is to find a safe and effective dose of the new medicine.
It's an early-stage study, meaning it's one of the first times humans are receiving the drug.
You must be 18 or older to be considered for participation.

Who may be eligible?

To be able to take part in this study, you must be 18 years old or older. There is no upper age limit, meaning people of all adult ages can be considered. Both men and women can participate in this research.

Critically, this study is designed for individuals who have multiple myeloma that has either returned after being treated before (we call this 'relapsed') or hasn't improved with previous treatments ('refractory'). This means that if your current treatments are working well for you, this study might not be suitable at this time.

There will also be other specific medical checks and requirements that the study doctors will go through with you. These are to make sure that it's safe for you to take part and that the study results will be meaningful. Your doctor or the study team will be able to explain all these details to 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?
Have you been diagnosed with multiple myeloma?
Has your multiple myeloma come back after previous treatment?
Has your multiple myeloma not improved with treatments you've already tried?
Are you able to attend regular appointments for tests and treatment?

Answer every question to see your result.

What does participation involve?

The detailed description of what taking part involves is not provided in your brief. However, typically for an early-stage study like this, you can expect to visit the clinic frequently, especially at the beginning. These visits would involve various tests such as blood tests, possibly urine tests, and other medical examinations to check your general health and how your body is reacting to the new medicine. You would receive the study medicine, CC-92328, likely for a set period. There would also be follow-up appointments after you stop taking the medicine to monitor your health and any long-term effects. The total duration of your participation would be explained by the study team.

Potential risks and benefits

Participating in an early-stage study like this might offer a potential benefit: you could be among the first to receive a new treatment for your multiple myeloma that might help when other treatments haven't. However, because this is a new medicine, there might be unknown side effects or risks. The research team will carefully monitor you for any problems, but it's important to understand that the full range of effects isn't yet known. You have the right to withdraw from the study 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 is multiple myeloma?

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

What does 'relapsed and/or refractory' mean?

It means your multiple myeloma has either come back after being treated before, or it hasn't responded well to previous treatments you've tried.

What is a Phase 1 study?

A Phase 1 study is an early-stage clinical trial where a new medicine is given to people for the first time. The main goal is to find a safe dose and see how it affects the body.

Will I definitely get the new drug?

If you join this specific study, you will receive the new drug being tested, CC-92328, as it's designed to find the right dose of this medicine.

Can I stop participating in the study if I want to?

Yes, you can choose to leave the study at any time, for any reason. This decision will not affect your future medical care.