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ReclutamentoFASE2INTERVENTISTICO

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.

A colpo d'occhio

Stato
Reclutamento
Fase
FASE2
Sponsor
Janssen Ricerca & Sviluppo, LLC
Obiettivo di iscrizione
510
Inizio
01 Feb 2021
Completamento stimato
30 Mar 2029

Di cosa tratta questo studio?

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.

Punti chiave

  • 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 partecipazione è volontaria e puoi ritirarti in qualsiasi momento.

Chi può essere idoneo?

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.

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 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?
Rispondi a ogni domanda per vedere il tuo risultato.

Cosa comporta la partecipazione?

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.

Rischi e benefici potenziali

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)

  • Università dell'Alabama a Birmingham
    Codice postale verificato
    Birmingham, Stati Uniti· Reclutamento
  • Università dell'Arkansas per le Scienze Mediche
    Codice postale verificato
    Little Rock, Stati Uniti· Reclutamento
  • Città della Speranza
    Codice postale verificato
    Duarte, Stati Uniti· Completato
  • Memorial Healthcare System
    Codice postale verificato
    Hollywood, Stati Uniti· Reclutamento
  • Istituto per il Cancro Winship dell'Università di Emory
    Codice postale verificato
    Atlanta, Stati Uniti· Reclutamento
  • University of Chicago
    Codice postale verificato
    Chicago, Stati Uniti· Reclutamento
  • Norton Cancer Institute
    Codice postale verificato
    Louisville, Stati Uniti· Reclutamento
  • University of Michigan Health System
    Codice postale verificato
    Ann Arbor, Stati Uniti· Reclutamento
  • Washington University School Of Medicine
    Codice postale verificato
    St Louis, Stati Uniti· Reclutamento
  • NYU Langone Health
    Codice postale verificato
    New York, Stati Uniti· Attivo ma non reclutante
  • Centro Medico Monte Sinai
    Codice postale verificato
    New York, Stati Uniti· Reclutamento
  • Centro Medico dell'Università di Rochester
    Codice postale verificato
    Rochester, Stati Uniti· Reclutamento

Domande comuni

What is talquetamab?

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

Who is this study for?

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

What does 'relapsed or refractory' mean?

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.

Posso abbandonare lo studio se cambio idea?

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

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