A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma
This study is looking into a new drug called etentamig for adults with multiple myeloma, a type of blood cancer, that has either returned or isn't getting better with usual treatments. Etentamig will be given in combination with other common multiple myeloma medicines like dexamethasone, lenalidomide, pomalidomide, or daratumumab. The main goals are to check if these combinations are safe and to see if they help control the disease. This study aims to find the best dose of etentamig and will involve about 320 patients from around the world. Participants will receive treatments in monthly cycles and have regular checks to monitor their health and the treatment's effects. It's a Phase 1 study, meaning it's an early look at this new treatment.
At a glance
What is this study about?
This study is about exploring a new medication called etentamig for people living with multiple myeloma. Multiple myeloma is a cancer that affects certain cells in your bone marrow, called plasma cells. For some people, despite treatment, the cancer can come back (relapse) or simply not respond well to existing therapies (refractory). This study focuses on these adults.
The main aim is to understand how safe etentamig is when given together with other treatments you might already be familiar with, such as dexamethasone, lenalidomide, pomalidomide, or daratumumab. The researchers also want to see if these combinations can help reduce the amount of cancer in your body. Etentamig is currently an 'investigational' drug, which means it's still being tested and is not yet available as a standard treatment.
About 320 adults worldwide are expected to take part in this study. The first part of the study will help doctors figure out the safest and most effective dose of etentamig. Once that's decided, more participants will join to confirm that dose. You would likely be placed into a group that receives one of the specified combinations, and these treatments are given in cycles, typically lasting 28 days each.
Key takeaways
- This study tests a new drug, etentamig, for relapsed/refractory multiple myeloma.
- Etentamig is given with other existing multiple myeloma treatments.
- The main goals are to check safety and if the treatment helps control the disease.
- About 320 adults worldwide will take part in this Phase 1 study.
- Participants will have regular visits for medical checks, blood tests, and to report side effects.
- It's a voluntary study, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you must be an adult aged 18 or over and have a confirmed diagnosis of multiple myeloma that has either returned after previous treatment or isn't responding.
You also need to be well enough to take part, meaning you can largely take care of yourself without too much difficulty. Your doctors must be able to measure your disease, and you should not have received etentamig or a similar type of treatment (called BCMA-targeted therapy) before. Depending on which part of the study you might join, you would generally need to have tried at least one to three or even more previous treatments for your multiple myeloma.
There are certain reasons why you might not be able to join. For example, if you've recently had a stem cell transplant, or if you have other serious health conditions that are not well controlled, like severe diabetes or certain infections. Also, if you have severe nerve pain (neuropathy grade 3 or above) or certain types of multiple myeloma that the study isn't able to look at, you might not be eligible. The study team will review all of your health information carefully to see if it's right for you.
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 older?
- Have you been diagnosed with multiple myeloma that has come back or isn't getting better?
- Are you generally well enough to manage day-to-day activities?
- Have you *not* received etentamig or similar 'BCMA-targeted' treatments before?
- Do you not have other serious, uncontrolled health issues like severe diabetes or infections?
- Have you not had a stem cell transplant very recently (within the last year for some types)?
What does participation involve?
If you join this study, you will receive etentamig, which is given directly into a vein (intravenously or IV), along with other study medicines. These other medicines might be taken by mouth, given into a vein, or injected under the skin. Your treatment will be given in cycles, with each cycle lasting 28 days.
Throughout the study, you'll need to visit an approved hospital or clinic regularly. These visits are important for doctors to check your health, how you're responding to the treatment, and if you're experiencing any side effects. These checks will involve medical assessments, blood tests, and filling out questionnaires. Because this is a research study, you might have more appointments and tests than you would with standard care. The medical team will closely monitor you every step of the way.
Potential risks and benefits
Locations (49)
- University of Arkansas for Medical Sciences /ID# 243096Verified postcodeLittle Rock, United States
- Sylvester Comprehensive Cancer Center /ID# 243673Verified postcodeMiami, United States
- Moffitt Cancer Center /ID# 243437Verified postcodeTampa, United States
- University of Maryland, Baltimore /ID# 243679Verified postcodeBaltimore, United States
- Dana-Farber Cancer Institute /ID# 249529Verified postcodeBoston, United States
- University of Massachusetts - Worcester /ID# 243977Verified postcodeWorcester, United States
- University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438Verified postcodeAnn Arbor, United States
- The Valley Hospital /ID# 243829Verified postcodeParamus, United States
- Rutenberg Cancer Center /ID# 244647Verified postcodeNew York, United States
- Memorial Sloan Kettering Cancer Center /ID# 244656Verified postcodeNew York, United States
- Atrium Health Levine Cancer Institute /ID# 242851Verified postcodeCharlotte, United States
- University of Texas Southwestern Medical Center /ID# 243273Verified postcodeDallas, United States
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that starts in plasma cells, which are immune cells found in your bone marrow.
What does 'relapsed/refractory' mean?
It means your multiple myeloma has either come back after treatment or isn't responding to standard treatments.
What is etentamig?
Etentamig is an experimental drug being tested to treat multiple myeloma. It's not yet a standard treatment.
What is a 'Phase 1' study?
A Phase 1 study is an early stage of research. It mainly focuses on finding a safe dose and checking for side effects of a new treatment.
Will I know if I'm getting the new drug?
Yes, all participants in this study will receive etentamig along with one of the other specified cancer medicines.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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