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A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

This research study is about a new medication called teclistamab, designed for individuals living with multiple myeloma. This is a type of blood cancer that affects plasma cells. The study is particularly for those whose multiple myeloma has either returned after previous treatments (relapsed) or hasn't responded well to other therapies (refractory). The main goal is to find out how effective teclistamab is at a specific, recommended dose. By carefully studying its effects, researchers hope to understand if this new treatment could be a valuable option for patients who have limited choices left.

Em resumo

Status
Ativo, mas não recrutando
Fase
FASE2
Patrocinador
Janssen Pesquisa & Desenvolvimento, LLC
Meta de inscrição
194
Iniciar
17 Sep 2020
Conclusão estimada
28 May 2027

Sobre o que é este estudo?

This study is looking into a new treatment called teclistamab for a type of blood cancer called multiple myeloma. Multiple myeloma affects important cells in your bone marrow. Sometimes, after initial treatments, the cancer can return (this is called relapsed) or it might not get better with the treatments tried so far (this is called refractory).

Teclistamab is designed to target specific cells involved in multiple myeloma. The researchers want to see how well this new medicine works in patients who have already had several other treatments, including specific types of drugs. They've identified a particular dose of teclistamab that they believe might be effective, and this study will help them confirm that.

The information gathered from this study is very important. It will help doctors understand more about teclistamab and whether it could become a new option for patients with multiple myeloma, especially those who have found their cancer hard to treat with existing therapies.

Pontos principais

  • This study is testing a new medicine, teclistamab, for multiple myeloma.
  • It's for people whose cancer has returned or didn't respond to other treatments.
  • The study aims to see how effective teclistamab is at a specific dose.
  • Participants must have tried several previous treatments for their multiple myeloma.
  • Careful monitoring of your health will be part of the study.

Quem pode ser elegível?

To join this study, you would need to have a clear diagnosis of multiple myeloma that meets specific medical standards. Your general health and ability to perform daily activities would also be assessed, typically needing to be quite good. The study is for adults aged 18 and older, and it includes both men and women.

Critically, for some parts of the study, you must have already tried at least three different types of multiple myeloma treatments, including certain common medications like PIs, IMiDs, and anti-CD38 monoclonal antibodies. For other parts of the study, you would also need to have tried a treatment that targets something called BCMA.

There are also some reasons you wouldn't be able to join. For example, if you have other serious medical conditions like certain heart problems, lung issues needing oxygen, or certain infections (like HIV or hepatitis B/C). If you've recently had a stroke or seizure, or certain other types of blood cancers, you also wouldn't be able to participate. Also, you shouldn't have had other anti-cancer treatments too close to the start of the study.

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.

  1. Do you have a clear diagnosis of multiple myeloma?
  2. Você tem 18 anos ou mais?
  3. Have you already had at least three different types of multiple myeloma treatments?
  4. Are you generally in good health otherwise?
  5. Do you not have certain serious heart, lung, or infectious conditions?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you decide to take part in this study, you would receive the new medicine, teclistamab. The study will involve regular visits to the clinic so the medical team can monitor your health and how you are responding to the treatment. This will include blood tests, physical examinations, and possibly other scans or checks to see the effect on your multiple myeloma. You would need to follow specific instructions about the medication and any other study rules. The total duration of your participation would depend on how you respond to the treatment and the study's design.

Riscos e benefícios potenciais

Taking part in this study could offer the potential benefit of trying a new treatment for your multiple myeloma, especially if other treatments haven't worked well for you. However, as with any new medicine, there might be side effects or risks that are not fully known yet. The study team will carefully monitor you for any such effects. You should always discuss potential risks and benefits with your doctor. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (51)

  • Universidade do Alabama em Birmingham
    Código postal verificado
    Birmingham, Estados Unidos
  • Cidade da Esperança
    Código postal verificado
    Duarte, Estados Unidos
  • Universidade da Califórnia, São Francisco
    Código postal verificado
    São Francisco, Estados Unidos
  • Stanford University Medical Center
    Código postal verificado
    Stanford, Estados Unidos
  • Winship Cancer Institute Emory University
    Código postal verificado
    Atlanta, Estados Unidos
  • Barbara Ann Karmanos Cancer Institute
    Código postal verificado
    Detroit, Estados Unidos
  • Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects
    Código postal verificado
    Nova Iorque, Estados Unidos
  • Memorial Sloan-Kettering Cancer Center
    Código postal verificado
    Nova Iorque, Estados Unidos
  • Instituto de Câncer Levine
    Código postal verificado
    Charlotte, Estados Unidos
  • Universidade da Pensilvânia
    Código postal verificado
    Filadélfia, Estados Unidos
  • Universitair Ziekenhuis Gent - UZ GENT
    Código postal verificado
    Gante, Bélgica
  • Universitaire Ziekenhuizen Leuven
    Código postal verificado
    Leuven, Bélgica

Perguntas frequentes

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects plasma cells, which are important white blood cells found in your bone marrow.

O que significa 'recidivado ou refratário'?

It means your cancer has either come back after treatment or hasn't responded well to the treatments you've tried so far.

What is teclistamab?

Teclistamab is the name of the new medicine being tested in this study for treating multiple myeloma.

Este é um novo tratamento?

Yes, this is a 'Phase 2' study, which means it's still in the stages of being tested to see how well it works.

Will I get regular checks during the study?

Yes, you will have regular medical check-ups and tests to see how you're doing and how the treatment is affecting you.

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.