A Study to Assess Adverse Events and Change in Disease Activity of Oral Surzetoclax Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM)
This study is testing a new drug called surzetoclax for adults with multiple myeloma, a type of blood cancer, that has either returned or not improved with previous treatments. We want to find out how safe surzetoclax is and how well it helps control the disease. Sometimes, surzetoclax will be given on its own, and other times, it will be combined with existing myeloma medicines like daratumumab, dexamethasone, or pomalidomide. The study involves about 130 adult participants around the world, including in the UK. Participants will attend regular hospital visits for check-ups and to receive treatment. The total study is expected to last for about four and a half years. This research aims to find better treatments for people with this type of multiple myeloma.
At a glance
What is this study about?
Multiple myeloma is a type of cancer that affects plasma cells, which are a type of white blood cell found in your bone marrow. These cells are important for fighting infections. In multiple myeloma, these plasma cells grow out of control, which can cause problems in the body.
This study, called a clinical trial, is looking at a new medicine named surzetoclax. We want to understand how safe this new drug is and how well it helps manage multiple myeloma, especially in people whose cancer has come back after treatment or hasn't responded to other medicines. Scientists believe surzetoclax might work by targeting specific features of myeloma cells, particularly those with a certain genetic change (t(11;14)) or high levels of a protein called BCL2.
The study will test surzetoclax in a few ways. Some participants might receive surzetoclax by itself, while others will get it along with other approved medicines for multiple myeloma, such as daratumumab, dexamethasone, and pomalidomide. This helps us see if surzetoclax works better alone or in combination. We’ll be carefully monitoring participants for any side effects and checking if their disease activity changes.
Key takeaways
- This study is for adults with multiple myeloma that has come back or not responded to previous treatments.
- It's testing a new drug called surzetoclax, both alone and with other medicines.
- The main goals are to check how safe surzetoclax is and how well it helps control the disease.
- You will have regular hospital visits for treatments and health checks.
- The study has specific requirements for who can take part, based on earlier treatments and myeloma features.
- You can stop participating in the study at any time.
Who may be eligible?
To join this study, adults must have multiple myeloma that has already been diagnosed and confirmed by doctors. Your myeloma treatments must have included certain types of drugs in the past, and your cancer needs to have come back or not responded to previous treatments. Importantly, your myeloma should show specific features, like a genetic change called t(11;14) or high levels of a protein called BCL2. You also shouldn't have been treated with a BCL-2 inhibitor medicine before.
There are also some reasons why people might not be able to join. For example, if you've had major surgery recently or are planning one soon, or if you have an active infection that hasn't cleared up before the study starts. The doctors running the study will carefully check all these details to make sure the study is right for you and safe.
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 an adult aged 18 or over?
- Do you have a confirmed diagnosis of multiple myeloma?
- Has your multiple myeloma come back or not responded to previous treatments?
- Has your doctor confirmed that your myeloma has specific features, such as t(11;14) or high BCL2 levels?
- Have you *not* been treated before with a BCL-2 inhibitor drug?
What does participation involve?
If you decide to take part in this study, you will have regular visits to an approved hospital or clinic. These visits are important for the doctors to monitor your health, give you the study medication, and check for any side effects. You'll likely have blood tests and other medical assessments frequently to see how the treatment is affecting you and your myeloma.
The study medication, surzetoclax, is given as a tablet you swallow. Other medicines in the study might be given as an injection under the skin or also as tablets. The total time you would be in the study is about four and a half years, including both treatment and follow-up periods. This might mean more appointments than you would usually have with your standard care.
Potential risks and benefits
Locations (46)
- University of Southern California /ID# 272414Verified postcodeLos Angeles, United States· Recruiting
- Yale University School of Medicine /ID# 272447Verified postcodeNew Haven, United States· Recruiting
- Dana-Farber Cancer Institute /ID# 271846Verified postcodeBoston, United States· Recruiting
- University of Michigan Health System - Ann Arbor /ID# 271536Verified postcodeAnn Arbor, United States· Recruiting
- Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 271214Verified postcodeNew York, United States· Recruiting
- University of North Carolina at Chapel Hill /ID# 272454Verified postcodeChapel Hill, United States· Recruiting
- Atrium Health Levine Cancer Institute /ID# 271510Verified postcodeCharlotte, United States· Recruiting
- Wake Forest Baptist Health /ID# 271294Verified postcodeWinston-Salem, United States· Recruiting
- University of Texas - Southwestern Medical Center /ID# 271914Verified postcodeDallas, United States· Recruiting
- Northwest Medical Specialties Tacoma /ID# 272506Verified postcodeTacoma, United States· Recruiting
- Liverpool Hospital /ID# 272002Verified postcodeLiverpool, Australia· Recruiting
- Calvary Mater Newcastle /ID# 272498Verified postcodeWaratah, Australia· Recruiting
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects certain white blood cells called plasma cells, which are found in your bone marrow.
What is surzetoclax?
Surzetoclax is a new medicine being tested in this study. It's an 'investigational drug', meaning it's not yet approved for general use.
Will I get surzetoclax alone or with other drugs?
Depending on which part of the study you join, you might receive surzetoclax by itself or with other standard myeloma medications.
How long will the study last?
The full study is expected to last for about four and a half years, including your treatment and follow-up.
Can I leave the study if I want to?
Yes, you can choose to leave the study at any time, for any reason, without it affecting your regular medical care.
How to find out more
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Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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