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Aktiv, aber nicht rekrutierendPHASE2INTERVENTIONELL

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.

Auf einen Blick

Status
Aktiv, aber nicht rekrutierend
Phase
PHASE2
Sponsor
Janssen Research & Development, LLC
Einschreibeziel
194
Starten
17 Sep 2020
Geschätzte Fertigstellung
28 May 2027
Hämatologische Malignome

Worum geht es in dieser Studie?

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.

Wichtige Erkenntnisse

  • 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.

Wer könnte berechtigt sein?

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.

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

  1. Do you have a clear diagnosis of multiple myeloma?
  2. Sind Sie 18 Jahre alt oder älter?
  3. Have you already had at least three different types of multiple myeloma treatments?
  4. Sind Sie ansonsten im Allgemeinen bei guter Gesundheit?
  5. Do you not have certain serious heart, lung, or infectious conditions?
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

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.

Potenzielle Risiken und Vorteile

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.

Standorte (51)

  • Universität von Alabama in Birmingham
    Verifizierte Postleitzahl
    Birmingham, Vereinigte Staaten
  • Stadt der Hoffnung
    Verifizierte Postleitzahl
    Duarte, Vereinigte Staaten
  • Universität von Kalifornien San Francisco
    Verifizierte Postleitzahl
    San Francisco, Vereinigte Staaten
  • Stanford Universitätsklinikum
    Verifizierte Postleitzahl
    Stanford, Vereinigte Staaten
  • Winship Cancer Institute Emory University
    Verifizierte Postleitzahl
    Atlanta, Vereinigte Staaten
  • Barbara Ann Karmanos Krebsinstitut
    Verifizierte Postleitzahl
    Detroit, Vereinigte Staaten
  • Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects
    Verifizierte Postleitzahl
    New York, Vereinigte Staaten
  • Memorial Sloan-Kettering Cancer Center
    Verifizierte Postleitzahl
    New York, Vereinigte Staaten
  • Levine Cancer Institute
    Verifizierte Postleitzahl
    Charlotte, Vereinigte Staaten
  • Universität von Pennsylvania
    Verifizierte Postleitzahl
    Philadelphia, Vereinigte Staaten
  • Universitair Ziekenhuis Gent - UZ GENT
    Verifizierte Postleitzahl
    Gent, Belgien
  • Universitaire Ziekenhuizen Leuven
    Verifizierte Postleitzahl
    Leuven, Belgien

Häufige Fragen

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.

Ist dies eine neue Behandlung?

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.

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