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

This study is looking into a new treatment called talquetamab for people with multiple myeloma. This is a type of blood cancer that affects the bone marrow. We are focusing on patients whose cancer has either returned after previous treatment or has stopped responding to other medicines. The study is particularly interested in understanding if talquetamab is effective and safe when given at specific doses. Researchers will be checking various aspects of the treatment to make sure it's helpful and well-tolerated. This is a Phase 2 study, which means it builds on earlier research and aims to gather more information about the drug's benefits and any side effects people might experience.

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Estado
Reclutamiento
Fase
FASE2
Patrocinador
Janssen Research & Development, LLC
Objetivo de inscripción
510
Inicio
01 Feb 2021
Estimación de finalización
30 Mar 2029

¿De qué trata este estudio?

This study is about a new medicine called talquetamab. It's being tested for people who have multiple myeloma, which is a type of cancer that develops in a certain kind of white blood cell called plasma cells in the bone marrow. This condition can cause serious health problems if not treated.

Specifically, this research is for individuals whose multiple myeloma has either returned after they've had other treatments, or if their current treatments are no longer working. We call this 'relapsed or refractory' multiple myeloma. The main aim of the study is to find out how well talquetamab works to control the cancer and how safe it is for patients. This is really important to help us understand if this new treatment could be a good option for people in the future.

The study is currently in Phase 2. This means that researchers have already done some initial tests with talquetamab and found it promising. Now, they need to gather more detailed information about its effectiveness and any potential side effects when given at certain doses. The hope is that talquetamab could offer another treatment choice for those living with multiple myeloma.

Puntos clave

  • New medicine, talquetamab, for multiple myeloma.
  • For cancer that has returned or is not responding to other treatments.
  • Aims to check how well the medicine works and if it's safe.
  • Regular check-ups and tests will be part of the study.
  • La participación es voluntaria, y puedes retirarte en cualquier momento.

¿Quién puede ser elegible?

To be able to join this study, your doctor must first confirm that you have multiple myeloma. This diagnosis needs to meet specific international guidelines. Your cancer also needs to be measurable, meaning doctors can track its progress with tests, either through a central lab or your local lab depending on which part of the study you might join. You should also generally be well enough to take part in a study, meaning you can carry out most of your normal daily activities without too much difficulty.

There are also some important things that might mean you can't join. For example, if you've recently had certain types of immunotherapy treatment (like CAR-T or T-cell redirection therapy), you might not be eligible, though the exact timing varies depending on which group in the study you might be in. Any side effects from your previous cancer treatments should have mostly cleared up – generally back to how they were before, or only very mild. You also shouldn't have taken a high dose of steroid medicines in the two weeks before starting the study drug, unless it was for a one-off treatment. Serious health events like a stroke or seizure within the last six months would also mean you couldn't participate in this study.

Also, if you are a woman who could become pregnant, you would need to have a negative pregnancy test before starting the study medicine. Everyone joining the study must be willing and able to follow all the study's rules and treatment plan.

¿Podría este estudio ser adecuado para ti?

Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.

  1. Do I have multiple myeloma that has come back or isn't responding to treatment?
  2. Has my multiple myeloma been officially diagnosed by a doctor?
  3. Am I generally well enough to do most of my daily activities?
  4. Have I avoided certain immune-boosting cancer therapies recently (ask your doctor for details)?
  5. Have any side effects from my previous treatments mostly cleared up?
  6. If I am a woman, am I willing to have a pregnancy test before starting the study?
Responde cada pregunta para ver tu resultado.

¿En qué consiste la participación?

If you decide to take part in this study, you will be given the study medicine, talquetamab. The specific details of how often and for how long you receive the treatment will be carefully explained to you by the study team. You will have regular visits to the clinic so the doctors can monitor your health, check how you're responding to the treatment, and look for any side effects. These visits will involve various assessments, such as blood tests, physical examinations, and potentially other scans or tests to measure your multiple myeloma. Your doctors will explain all scheduled appointments and tests to you.

The total duration of your participation in the study will depend on how you respond to the treatment and the study plan. Even after you stop receiving the study medicine, you will likely have some follow-up visits or contact to ensure your health is still being monitored. The study team will make sure you understand the full schedule and commitment involved before you make any decisions.

Riesgos y beneficios potenciales

Taking part in any clinical study comes with potential benefits and risks. The main potential benefit of this study is that talquetamab might help to control your multiple myeloma, especially if other treatments haven't worked or your cancer has returned. This new medicine could potentially offer an improved quality of life or lengthen the time your cancer is under control. However, there's no guarantee that it will work for everyone, and it might not work as expected. Like all medicines, talquetamab can have side effects. The study team will explain all the known and potential side effects to you. They will monitor you closely throughout the study for any reactions and manage them to ensure your safety and comfort. Remember, deciding whether or not to join is completely up to you, and you can withdraw from the study at any time without it affecting your usual medical care.

Locations (78)

  • University of Alabama Birmingham
    Código postal verificado
    Birmingham, United States· Reclutamiento
  • University of Arkansas for Medical Sciences
    Código postal verificado
    Little Rock, Estados Unidos· Reclutamiento
  • City of Hope
    Código postal verificado
    Duarte, Estados Unidos· Completado
  • Memorial Healthcare System
    Código postal verificado
    Hollywood, Estados Unidos· Reclutamiento
  • Emory University Winship Cancer Institute
    Código postal verificado
    Atlanta, Estados Unidos· Reclutamiento
  • University of Chicago
    Código postal verificado
    Chicago, Estados Unidos· Reclutamiento
  • Norton Cancer Institute
    Código postal verificado
    Louisville, Estados Unidos· Reclutamiento
  • University of Michigan Health System
    Código postal verificado
    Ann Arbor, Estados Unidos· Reclutamiento
  • Escuela de Medicina de la Universidad de Washington
    Código postal verificado
    San Luis, Estados Unidos· Reclutamiento
  • NYU Langone Health
    Código postal verificado
    Nueva York, Estados Unidos· Activo, no reclutando
  • Mount Sinai Medical Center
    Código postal verificado
    Nueva York, Estados Unidos· Reclutamiento
  • University of Rochester Medical Center
    Código postal verificado
    Rochester, United States· Reclutamiento

Preguntas comunes

What is talquetamab?

Talquetamab is a new medicine being tested for people with multiple myeloma, a type of blood cancer.

¿Para quién es este estudio?

This study is for adults whose multiple myeloma has either come back or is not responding to other treatments.

¿Qué significa 'recaída o refractario'?

It means the cancer has returned after previous treatment or is not responding to current treatments.

Will I get the actual study drug?

Yes, in this Phase 2 study, all participants will receive the study drug, talquetamab.

¿Puedo abandonar el estudio si cambio de opinión?

Yes, you can choose to leave the study at any time, and it won't affect your future medical care.

Cómo obtener más información

Study Contact

Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.

¿Interesado en participar?

Registra tu interés

Comparte tus detalles y el equipo de investigación para "A Study of Talquetamab in Participants With Relapsed or Refr…" se pondrá en contacto contigo si puedes ser elegible. Siempre habla con tu médico antes de aceptar participar.

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