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Attivo ma non reclutanteFASE2INTERVENTISTICO

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.

A colpo d'occhio

Stato
Attivo ma non reclutante
Fase
FASE2
Sponsor
Janssen Ricerca & Sviluppo, LLC
Obiettivo di iscrizione
194
Inizio
17 Sep 2020
Completamento stimato
28 May 2027

Di cosa tratta questo studio?

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.

Punti chiave

  • 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.

Chi può essere idoneo?

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.

Questo studio potrebbe fare al caso tuo?

Rispondi a queste domande rapide per vedere se potresti essere idoneo. Questo è solo una guida — il team di ricerca prende la decisione finale.

  1. Do you have a clear diagnosis of multiple myeloma?
  2. Hai 18 anni o più?
  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?
Rispondi a ogni domanda per vedere il tuo risultato.

Cosa comporta la partecipazione?

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.

Rischi e benefici potenziali

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)

  • Università dell'Alabama a Birmingham
    Codice postale verificato
    Birmingham, Stati Uniti
  • Città della Speranza
    Codice postale verificato
    Duarte, Stati Uniti
  • University of California San Francisco
    Codice postale verificato
    San Francisco, Stati Uniti
  • Stanford University Medical Center
    Codice postale verificato
    Stanford, United States
  • Winship Cancer Institute Emory University
    Codice postale verificato
    Atlanta, Stati Uniti
  • Barbara Ann Karmanos Cancer Institute
    Codice postale verificato
    Detroit, Stati Uniti
  • Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects
    Codice postale verificato
    New York, Stati Uniti
  • Memorial Sloan-Kettering Cancer Center
    Codice postale verificato
    New York, Stati Uniti
  • Levine Cancer Institute
    Codice postale verificato
    Charlotte, Stati Uniti
  • University of Pennsylvania
    Codice postale verificato
    Philadelphia, Stati Uniti
  • Universitair Ziekenhuis Gent - UZ GENT
    Codice postale verificato
    Gand, Belgio
  • Universitaire Ziekenhuizen Leuven
    Codice postale verificato
    Lovanio, Belgio

Domande comuni

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.

What does 'relapsed or refractory' mean?

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.

È questo un nuovo trattamento?

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.

Come saperne di più

Parla sempre con il tuo medico di base o specialista prima di decidere di partecipare a uno studio.

Discussione

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