RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma

This research study is for people in the UK with multiple myeloma that has either returned after previous treatment or isn't responding to current therapies. We're testing new combinations of drugs, including CC-92480, to see how safe they are and how the body handles them. We also want to find out if these combinations show early promise in treating multiple myeloma. This study is in its early stages (Phase 1 and Phase 2), meaning we're carefully exploring the best ways to use these treatments and monitoring participants closely to ensure their well-being. The aim is to find better treatment options for those who need them most.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Bristol-Myers Squibb

Enrolment target

260

Start

18 Oct 2022

Estimated completion

12 Oct 2026

Multiple Myeloma

What is this study about?

This study is focused on a type of blood cancer called multiple myeloma. Sometimes, after initial treatments, multiple myeloma can come back or stop responding to the medicines. This is often called 'relapsed' or 'refractory' multiple myeloma.

Researchers are looking into new ways to tackle this. They are trying out a new drug called CC-92480 (also known as BMS-986348) in combination with other existing treatments. The main goals are to understand if these new combinations are safe to use, how the body handles the drugs (like how much medicine stays in the blood), and if they show early signs of helping to control the multiple myeloma.

This study is in two main parts, called Phase 1 and Phase 2. In Phase 1, the focus is more on finding the right dose and making sure the drugs are safe. In Phase 2, they will look at more people to get a better idea of how well the drugs work. The hope is that these new combinations could offer more choices for people whose multiple myeloma is difficult to treat.

Key takeaways

This study is for multiple myeloma that hasn't responded to previous treatments.
It tests new drug combinations, including CC-92480, for safety and how well they work.
The study is in early stages (phases 1 and 2).
Close monitoring for side effects and effectiveness will take place.
Participation is voluntary, and you can withdraw at any time.
The aim is to find new and better treatment options.

Who may be eligible?

To be considered for this study, you must have multiple myeloma that has either returned after previous treatment or is not getting better with current treatments. You also need to have clear signs of the disease that can be measured.

Your general health and ability to do daily activities will be checked, and you'll need to be in reasonably good health overall. Women who can become pregnant will need to agree to use effective birth control throughout the study if they decide to take part.

There are also some reasons why you might not be able to join. For example, if your myeloma has spread to your brain or spinal cord, or if you have certain other serious health conditions, especially heart problems. If you've recently had other specific treatments, such as major surgery, radiation, or certain other drugs, in the last few weeks, you might also have to wait or may not be eligible.

Quick self-check

Do I have multiple myeloma that has come back or is not responding to treatment?
Do my doctors say I have signs of the disease that can be measured?
Am I generally well enough to do most of my daily activities?
Have I avoided certain major treatments (like surgery or radiation for other parts of the body) in the last few weeks?
Do I have any heart problems or has my myeloma spread to my brain or spinal cord?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will receive the study drugs (CC-92480 along with others like Tazemetostat, BMS-986158, Trametinib, or Dexamethasone), which will be given in combination. The specific treatment plan will depend on which part of the study you are in. You will have regular appointments at the hospital for check-ups, blood tests, and other assessments to monitor your health and how you are responding to the treatment.

These visits will help the doctors check for any side effects and see how the drugs are working. You will likely need to follow a pregnancy prevention plan if you are a woman who could become pregnant. The total length of your participation will vary, but there will be ongoing follow-up to ensure your safety and track your progress.

Potential risks and benefits

Taking part in a clinical trial can have potential benefits, such as gaining access to new treatments before they are widely available, which might help your condition when standard options haven't worked. However, there are also potential risks involved. The drugs being tested might cause side effects, some of which could be serious and unexpected. The treatment might not work for you, or it might not work as well as hoped. It's important to remember that you are free to withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (17)

UAB Comprehensive Cancer Center
Birmingham, United States· Recruiting
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, United States· Recruiting
Dana-Farber Cancer Institute
Boston, United States· Recruiting
John Theurer Cancer Center at Hackensack UMC
Hackensack, United States· Recruiting
Memorial Sloan Kettering Cancer Center
New York, United States· Recruiting
Alberta Health Services AHS - Foothills Medical Centre FMC
Calgary, Canada· Recruiting
University of Alberta - Cross Cancer Institute
Edmonton, Canada· Recruiting
University Health Network UHN - Princess Margaret Hospital PMH
Toronto, Canada· Recruiting
Oslo University Hospital
Oslo, Norway· Recruiting
ICO - Hospital Germans Trias i Pujol
Barcelona, Spain· Recruiting
Hospital Universitario 12 de Octubre
Madrid, Spain· Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Spain· Recruiting

+5 more sites — see the official record for the full list.

Common questions

What is 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.

What does 'relapsed or refractory' mean?

'Relapsed' means the cancer has come back after treatment. 'Refractory' means the cancer isn't responding to current treatments.

Are the drugs in this study new?

CC-92480 (BMS-986348) is a new drug being tested, often in combination with other treatments that might already be known.

What are 'Phase 1' and 'Phase 2' studies?

Phase 1 studies primarily check if a new treatment is safe and to find the right dose. Phase 2 studies then look at safety in more people and gather early information on how well the treatment works.

Will I have to pay for the treatment?

No, if you participate in an NHS clinical trial, the study drugs and related procedures are usually provided free of charge.

How to find out more

BMS Study Connect Contact Center www.BMSStudyConnect.com

Clinical.Trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.