Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 1/2 Multicenter, Open-label Study to Assess the Safety, Pharmacokinetics and Efficacy of CC-92480 Monotherapy and in Combination with Dexamethasone in Subjects with Relapsed and Refractory Multiple Myeloma

This research is a clinical trial exploring a new medication called CC-92480. It's for individuals diagnosed with multiple myeloma, a type of blood cancer, where their condition has either returned after treatment or not improved with earlier therapies. The study will carefully check how safe CC-92480 is, monitoring any side effects. Researchers will also learn how the body processes the medication and how effective it is at treating the myeloma. They will be testing CC-92480 by itself and in combination with an existing medicine called dexamethasone, to see if combining them works better. The main goal is to find the best and safest dose of CC-92480 and to see if it can help patients respond to treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Celgene Corp.

Enrolment target

Start

06 Feb 2024

Relapsed and refractory multiple myeloma (RRMM)

What is this study about?

This study is a clinical trial for people who have multiple myeloma that has either returned after earlier treatments or hasn't responded well to those treatments. Multiple myeloma is a type of cancer that affects plasma cells, a kind of white blood cell found in your bone marrow. When it comes back or doesn't improve, doctors look for new ways to help patients.

This trial is looking at a new medication called CC-92480. We want to understand how safe it is, what side effects it might cause, and how well it works. Researchers will be giving CC-92480 on its own and also in combination with another medicine called dexamethasone, which is already used to treat multiple myeloma. The study will help doctors find the best and safest amount of CC-92480 to give and see if it can make the cancer shrink or stop growing.

This kind of study, called a Phase 1/2 trial, is an important step in developing new treatments. Phase 1 focuses on safety and finding the right dose, while Phase 2 starts to look more closely at how well the treatment works. The information gathered from this study will help us understand if CC-92480 could be a helpful new option for people with this type of multiple myeloma in the future.

Key takeaways

This study evaluates a new drug, CC-92480, for multiple myeloma.
It's for patients whose myeloma has returned or not responded to previous treatments.
Researchers are testing the drug alone and with dexamethasone.
The main goals are to check safety, how the body handles the drug, and its effectiveness.
You'll have regular medical check-ups and monitoring if you join.
Participation involves possible benefits and risks; you can withdraw anytime.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women are welcome.

Crucially, you would need to have multiple myeloma that has either come back after past treatments or has not responded to those treatments. This means your doctors would have already tried other ways to manage your condition.

Beyond these general points, there will be specific health checks and tests to make sure that taking part in the study is right and safe for you. The study team will explain all the detailed requirements if you are interested.

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 not responded to previous treatments?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the new drug, CC-92480, either on its own or together with dexamethasone. You'll have regular hospital visits for check-ups, which will include physical examinations, blood tests, and other important checks like vital signs (like your blood pressure and heart rate). Some participants may also have heart scans (ECGs and ECHO/MUGA scans) to monitor their health carefully.

The study team will monitor you closely for any side effects or changes in your health. You'll need to follow a specific schedule for taking your medication and attending appointments. The total length of your participation will depend on how you respond to the treatment and the study plan, but you will be kept informed every step of the way.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and potential risks. A possible benefit could be that the new drug, CC-92480, helps manage your multiple myeloma when other treatments haven't worked. However, there's also a chance the drug might not help or could cause side effects. These side effects will be carefully monitored, and the research team will explain all known risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Belgium
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Unverified
Spain

Common questions

What is 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 your body fight infections.

What does 'relapsed and refractory' mean?

It means your multiple myeloma has either come back after previous treatments (relapsed) or hasn't responded well to those treatments (refractory).

What is CC-92480?

CC-92480 is a new medication being tested in this study to see if it can help treat multiple myeloma. It's not yet available outside of clinical trials.

What is dexamethasone?

Dexamethasone is a type of steroid medicine that is already used in combination with other drugs to treat multiple myeloma.

Will I definitely receive the new drug?

Yes, in this open-label study, all participants will receive CC-92480, either on its own or combined with dexamethasone. There is no placebo group.