A Study to Evaluate Adverse Events and Change in Disease Activity With Injected Etentamig Plus Oral Pomalidomide Versus Standard Therapies in Adults With Relapsed or Refractory Multiple Myeloma
This study is looking for adults with multiple myeloma, a type of blood cancer, whose disease has returned or hasn't responded well to previous treatments. They will have already had 1 to 3 different treatments, including one called lenalidomide. The main goal is to find out if a new medicine, Etentamig, given with Pomalidomide, is safe and can help control the disease better than standard treatments currently available. Etentamig is still being investigated. Some participants will receive the new combination, while others will get one of the usual treatments. The study will also look at any side effects people experience during the trial.
At a glance
What is this study about?
This study is designed for people who have multiple myeloma, a type of cancer that affects certain cells in the bone marrow and can cause problems like bone pain, infections, and kidney issues. In this study, we're looking at patients whose multiple myeloma has either come back after treatment (relapsed) or hasn't improved with earlier treatments (refractory). They will have already tried 1 to 3 different treatments, including a specific one called lenalidomide.
The main purpose of this study is to see how safe and effective a new medicine called Etentamig is when given together with Pomalidomide. Etentamig is still being researched, so it's not a standard treatment yet. We want to compare this new combination with other treatments that doctors normally use for multiple myeloma. This will help us understand if the new combination can help control the disease better and how it affects patients compared to existing options.
The study involves two parts. First, a small group will try the Etentamig and Pomalidomide combination to check its early safety. Then, a larger group will be randomly assigned to receive either the Etentamig and Pomalidomide combination or one of the standard treatments. The standard treatments include options like Daratumumab with Pomalidomide and Dexamethasone, Daratumumab with Carfilzomib and Dexamethasone, or Teclistamab. The study will carefully monitor all participants for side effects and how their disease responds to treatment.
Key takeaways
- This study evaluates a new treatment for multiple myeloma that has returned or not responded to previous therapies.
- It compares a new medicine (Etentamig with Pomalidomide) against standard treatments.
- Participants must have had 1-3 prior treatments for multiple myeloma, including lenalidomide.
- Safety and how well the treatment controls the disease are the main focus.
- Participation involves regular hospital visits for assessments and monitoring.
- It's a long-term study, lasting over six years.
Who may be eligible?
To be considered for this study, you must be an adult aged 18 or older. You should have been diagnosed with multiple myeloma that has either come back or is not responding to treatment. Importantly, you must have already received between one and three different treatments for your multiple myeloma, including a medicine called lenalidomide.
There are also some requirements about your general health. Your organs, like your kidneys and liver, need to be working well, and your overall fitness for daily activities needs to be at a certain level.
However, you would not be able to join this study if you've had a specific type of T-cell treatment before for your multiple myeloma, or if your cancer has spread to your brain or spinal cord. Also, if you’ve had other cancers in the last three years (with a few specific exceptions) or serious health conditions affecting your heart, lungs, or other major body systems recently, you might not be eligible.
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?
- Do you have multiple myeloma that has come back or isn't responding to treatment?
- Have you had at least 1, but no more than 3, previous treatments for your multiple myeloma, including lenalidomide?
- Are your major organs (like kidneys, liver) generally healthy?
- Have you NOT had a specific type of T-cell immune therapy for your multiple myeloma?
- Is your multiple myeloma NOT in your brain or spinal cord?
What does participation involve?
If you decide to take part in this study, you will have regular visits to a hospital or clinic. These visits are essential to keep a close eye on your health and how the treatment is affecting you. You'll have medical check-ups, blood tests, and doctors will ask about any side effects you might be experiencing. You may also need to fill out questionnaires.
Some medicines in this study are given by injection, while others are tablets you take by mouth. You will be monitored closely throughout. Taking part in this study might involve more hospital visits and procedures than your usual care. The total time for the study, from start to finish, is expected to be about six years and three months.
Potential risks and benefits
Locations (66)
- University of Arizona Cancer Center /ID# 285339Verified postcodeTucson, United States
- Toi Clinical Research - Whittier /ID# 284462Verified postcodeCerritos, United States
- University of California Los Angeles /ID# 282444Verified postcodeLos Angeles, United States
- University Of Colorado - Anschutz Medical Campus /ID# 283478Verified postcodeAurora, United States
- MedStar Georgetown University Hospital /ID# 283734Verified postcodeWashington D.C., United States
- Cleveland Clinic Florida /ID# 283692Verified postcodeWeston, United States
- Northwest Georgia Oncology Centers /ID# 284769Verified postcodeMarietta, United States
- Rush University Medical Center /ID# 283095Verified postcodeChicago, United States
- Beth Israel Deaconess Medical Center /ID# 285204Verified postcodeBoston, United States
- Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 282591Verified postcodeGrand Rapids, United States
- The Mount Sinai Hospital /ID# 283535Verified postcodeNew York, United States
- Columbia University Medical Center /ID# 283510Verified postcodeNew York, United States
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. It can lead to problems with your bones, blood, kidneys, and immune system.
What does 'relapsed or refractory' mean?
'Relapsed' means your multiple myeloma has come back after treatment. 'Refractory' means your multiple myeloma is not responding or has stopped responding to previous treatments.
What is an 'investigational drug'?
An investigational drug, like Etentamig, is a medicine that is still being tested in clinical studies and has not yet been approved for general use by the public.
Will I definitely get the new medicine?
This is a 'randomised' study, which means you will be put into a group by chance. You might receive the new medicine combination, or you might receive one of the standard treatments for multiple myeloma.
How long will I need to be involved in the study?
The total study duration is expected to be around 75 months, which is about six years and three months. This includes regular visits for assessments and monitoring.
How to find out more
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Always speak to your GP or specialist before deciding to take part in a study.
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