A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets
This research trial is testing a new drug called ABBV-453 for adults with multiple myeloma. This is a type of blood cancer that affects plasma cells in the bone marrow and has either returned after treatment or hasn't responded well to other therapies. The main goal is to check how safe ABBV-453 is and what side effects it might cause. Researchers also want to see if it helps to slow down or stop the progression of the disease. In the first part of the study, people will receive ABBV-453 on its own to find the best dose. In the second part, people will receive ABBV-453 combined with other existing treatments for multiple myeloma. Around 178 to 360 adults will take part across many hospitals worldwide.
At a glance
What is this study about?
Multiple myeloma is a type of cancer that affects special white blood cells called plasma cells in the bone marrow. When these cells grow abnormally, they can cause problems throughout the body. Sometimes, despite treatment, the myeloma can come back (this is called 'relapsed') or it might not respond well to existing medicines (known as 'refractory'). This can be a very challenging situation for patients and doctors.
This study is looking at a new medicine, ABBV-453, which is currently being developed. The main idea behind this trial is to carefully check if ABBV-453 is safe for people with multiple myeloma that has relapsed or is refractory. We also want to understand what side effects it might cause and how the body reacts to it. Importantly, the researchers will also be monitoring whether taking ABBV-453 helps to reduce the amount of myeloma in the body or stops it from growing.
This trial is divided into two main parts. In the first part, a smaller group of people will receive ABBV-453 on its own. This helps the researchers figure out the safest and most effective dose to use. In the second, larger part of the study, participants will be split into different groups. Each group will receive ABBV-453 combined with other established multiple myeloma treatments like Dexamethasone, Daratumumab, or Lenalidomide. This allows the researchers to see how ABBV-453 works alongside these other medicines and to compare different treatment approaches.
Key takeaways
- This study is for adults with multiple myeloma that has come back or hasn't responded to previous treatments.
- It's testing a new drug, ABBV-453, to see if it's safe and helps control the disease.
- You might receive ABBV-453 alone or combined with other existing myeloma medicines.
- Taking part means regular hospital visits for checks and tests.
- Your doctor will carefully check if this study is right for you, based on specific health requirements.
- You can stop participating in the study at any time if you wish.
Who may be eligible?
To join this study, your doctor will need to check if you meet certain requirements. You must be an adult aged 18 or older with multiple myeloma that has either returned or hasn't responded to previous treatments. It's important that your myeloma can be measured, meaning doctors can see and track it with tests.
For most parts of the study, you would have already tried and not responded well to several common myeloma treatments, including certain types of drugs called proteasome inhibitors, immunomodulatory drugs, and an anti-CD38 antibody. Your general health and ability to carry out daily activities will be assessed, and blood test results also need to be within specific ranges. In some cases, your myeloma cells might need to have a specific genetic feature (called t(11;14) or BCL2high status).
However, there are also reasons why you might not be able to join. For example, if you have significant heart problems. For some parts of the study, if you've previously taken certain drugs like venetoclax or other similar medicines, or a drug called daratumumab, you might not be eligible. Your study doctor will go through all these details with you carefully to see if this study is suitable.
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 that has returned or not responded to previous treatments?
- Can your doctors measure your multiple myeloma with tests?
- Have you already tried certain standard myeloma treatments?
- Are your general health and blood test results within specific ranges?
- Are you able to attend regular hospital visits for treatment and checks?
What does participation involve?
If you decide to take part in this study, you will be given ABBV-453 tablets to take by mouth every day, in cycles of 28 days. Depending on which part of the study you are in, you might also receive other treatments like Dexamethasone tablets, Daratumumab injections under the skin, or Lenalidomide capsules. These treatments will be continuous, meaning you'll keep taking them as long as the study doctor advises.
You will need to attend hospital or clinic visits regularly throughout the study. During these visits, the medical team will closely monitor your health, perform various medical checks, take blood samples, and ask about any side effects you might be experiencing. These frequent checks are important to see how you are responding to the treatment and to ensure your safety. The overall length of your participation will depend on how you respond to treatment and your individual situation, but you will be closely monitored throughout.
Potential risks and benefits
Locations (21)
- Stanford University School of Med /ID# 242809Verified postcodeStanford, United States
- Sylvester Comprehensive Cancer Center /ID# 243417Verified postcodeMiami, United States
- Tulane University School of Medicine /ID# 244854Verified postcodeNew Orleans, United States
- American Oncology Partners of Maryland /ID# 244858Verified postcodeBethesda, United States
- University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 242754Verified postcodeAnn Arbor, United States
- Mayo Clinic - Rochester /ID# 242844Verified postcodeRochester, United States
- Memorial Sloan Kettering Cancer Center /ID# 243503Verified postcodeNew York, United States
- Atrium Health Levine Cancer Institute /ID# 243420Verified postcodeCharlotte, United States
- Duke Univ Med Ctr /ID# 242808Verified postcodeDurham, United States
- Wake Forest Baptist Health /ID# 244252Verified postcodeWinston-Salem, United States
- University of Pennsylvania /ID# 242842Verified postcodePhiladelphia, United States
- Vanderbilt Ingram Cancer Center /ID# 242810Verified postcodeNashville, United States
Common questions
What is multiple myeloma?
It's a type of cancer that affects specialized white blood cells called plasma cells, found in the bone marrow. These cells can grow abnormally and cause problems.
What does 'relapsed or refractory' mean?
Relapsed means the cancer has come back after treatment. Refractory means the cancer hasn't responded well to previous treatments.
What is ABBV-453?
ABBV-453 is a new drug being tested in this study to see if it's safe and effective for treating multiple myeloma.
Will I get ABBV-453 alone or with other drugs?
In the first part of the study, you'd get ABBV-453 alone. In the second part, you'd get it alongside other known myeloma treatments like Dexamethasone, Daratumumab, or Lenalidomide.
How long will I be in the study?
The exact length will vary for each person. You will continue treatment and follow-up as long as your study doctor recommends, based on how you respond and how you Tolerate the treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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