A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma
This research study is exploring the combination of two new medicines, talquetamab and teclistamab, for individuals living with multiple myeloma. This is for people whose myeloma has either returned after previous treatments or hasn't responded well to them. The study has different stages: first, it aims to find the most suitable dose and schedule for these medicines when given together. Then, it will closely watch for any side effects to make sure the treatment is as safe as possible. Finally, for a specific group of patients whose myeloma has spread outside the bone marrow, the study will check how well this combination therapy works to fight the cancer. Ultimately, the goal is to discover a new and effective treatment option for those with challenging forms of multiple myeloma.
Em resumo
Sobre o que é este estudo?
This study is looking into two new medicines, talquetamab and teclistamab, for a type of blood cancer called multiple myeloma. Multiple myeloma affects cells in your bone marrow, and for many people, it can be a challenge to treat, especially when it comes back after treatment or doesn't respond to current medicines. This research is important because it's testing a combination of therapies, which might be more effective than using just one.
The study is happening in different steps. The first part is like figuring out a recipe: the researchers want to find the best amount of each medicine to give and how often to give it. They call this finding the "recommended Phase 2 regimen." Once they think they have a good plan, the next step is to carefully watch for any side effects to make sure the treatment is safe.
In the final part of the study, they will focus on a specific group of people with multiple myeloma where the cancer has spread beyond the bone marrow to other parts of the body. For these individuals, the study will see how well the combination of talquetamab and teclistamab works to shrink the cancer and stop its growth. The hope is that this research will lead to a new and better way to treat multiple myeloma, especially for those who have limited options.
Pontos principais
- This study is testing two new medicines, talquetamab and teclistamab, for challenging multiple myeloma.
- It's for people whose myeloma has come back or isn't responding to current treatments.
- The study aims to find the best dose, check for safety, and see how well the combination fights cancer.
- A participação envolve visitas regulares para tratamento e exames de saúde.
- You'll get access to new treatments, but there are potential side effects to consider.
- Você pode deixar o estudo a qualquer momento sem afetar seu atendimento normal.
Quem pode ser elegível?
To join this study, you would need to have a confirmed diagnosis of multiple myeloma. Importantly, your myeloma must have either returned after previous treatments or not responded well to them. For specific parts of the study, this means you must have had certain standard treatments, like particular types of drugs, and your disease must have worsened despite your last treatment.
You would also need to be generally well enough to take part. This is often checked using a simple score called ECOG, which looks at how well you can carry out daily activities. Depending on the part of the study, you would need an ECOG score of 0, 1, or 2, meaning you are either fully active, able to walk and do light work, or able to care for yourself but unable to do work.
There are also some reasons why you might not be able to join. For example, if you've recently had other trial medicines, specific types of cell transplants, or if your myeloma has spread to your brain or spinal cord. Also, certain other blood conditions like active plasma cell leukemia or Waldenström's macroglobulinemia would prevent you from taking part.
Este estudo pode ser adequado para você?
Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.
- Do I have a confirmed diagnosis of multiple myeloma?
- Has my multiple myeloma returned or stopped responding to previous treatments?
- Have I had particular standard myeloma treatments before?
- Am I generally well enough for daily activities (ECOG score of 0, 1, or 2)?
- Have I avoided other experimental treatments or certain types of transplants recently?
- Does my myeloma affect my brain or spinal cord, or do I have other specific blood conditions?
O que envolve a participação?
The study involves receiving two new medicines, talquetamab and teclistamab. You would have regular visits for blood tests, physical examinations, and to receive your treatment. The frequency of visits might change as the study progresses, usually being more frequent at the beginning and then becoming less often. All treatments and study-required assessments would be provided at no cost.
Throughout your participation, doctors and nurses will closely monitor your health and any side effects. You will be asked about your symptoms and how you are feeling at each visit. The total length of your participation would depend on how your myeloma responds to the treatment and what the study doctors decide is best for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.
Riscos e benefícios potenciais
Locations (40)
- University of Alabama at Birmingham, Comprehensive Cancer CenterCódigo postal verificadoBirmingham, Estados Unidos
- Universidade de Ciências Médicas do ArkansasCódigo postal verificadoLittle Rock, Estados Unidos
- Colorado Blood Cancer InstituteCódigo postal verificadoDenver, Estados Unidos
- Universidade EmoryCódigo postal verificadoAtlanta, Estados Unidos
- Clínica MayoCódigo postal verificadoRochester, Estados Unidos
- Washington University St. Louis School Medicine Siteman Cancer CenterCódigo postal verificadoSt Louis, Estados Unidos
- Mount Sinai Medical CenterCódigo postal verificadoNova Iorque, Estados Unidos
- Centro de Câncer Memorial Sloan KetteringCódigo postal verificadoNova Iorque, Estados Unidos
- Atrium HealthCódigo postal verificadoCharlotte, Estados Unidos
- Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer CenterCódigo postal verificadoWinston-Salem, Estados Unidos
- Cleveland ClinicCódigo postal verificadoCleveland, Estados Unidos
- Oregon Health And Science UniversityCódigo postal verificadoPortland, Estados Unidos
Perguntas frequentes
What is multiple myeloma?
Multiple myeloma is a type of cancer that develops from plasma cells, a type of white blood cell, found in the bone marrow. It can affect your bones, kidneys, immune system, and red blood cell count.
What do 'relapsed' or 'refractory' mean in this study?
'Relapsed' means your multiple myeloma has returned after getting better with previous treatment. 'Refractory' means your multiple myeloma didn't respond or stopped responding to the treatment you were receiving.
Are talquetamab and teclistamab approved medicines?
These are investigational medicines, meaning they are still being studied and are not yet fully approved for general use. They are given as part of a clinical trial to see if they are safe and effective.
Will I know if I'm getting the active treatment or a placebo?
In this specific study, all participants will receive the active study medicines, talquetamab and teclistamab. There is no placebo group.
Com quem posso falar se tiver mais perguntas?
You should discuss any questions or concerns you have about this study with your doctor or the research team. They can provide more detailed information tailored to your specific situation.
Como saber mais
Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.
Discussão
Discussão da comunidade
Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.