Tutti gli studi
AutorizzatoEsplorativo terapeutico (Fase II)Interventistico

Iceland Screens Treats or Prevents Multiple Myeloma (iStopMM): A nationwide phase 2 trial of patients with smoldering and active multiple myeloma (MM)

This study, called iStopMM, is a research project focused on multiple myeloma, a type of cancer that affects plasma cells in your blood. It's investigating if certain medications can effectively treat or even prevent this condition. The study is particularly interested in people who have an early form of the disease, called smoldering multiple myeloma (SMM), or those who already have more advanced multiple myeloma. Researchers want to see if these treatments can reduce the amount of cancer cells in the body to very low levels, known as "MRD negativity." This is a Phase 2 study, meaning it's still in the earlier stages of testing new treatments to see how well they work and if they are safe.

A colpo d'occhio

Stato
Autorizzato
Fase
Esplorativo terapeutico (Fase II)
Sponsor
Landspitali
Obiettivo di iscrizione
80
Inizio
11 Dec 2024

Di cosa tratta questo studio?

This research project, known as iStopMM, is looking into multiple myeloma, which is a type of cancer that affects specific cells in your bone marrow called plasma cells. These cells are part of your immune system. The study aims to find better ways to treat or prevent this condition from getting worse. Sometimes, people can have an early stage of multiple myeloma called 'smoldering multiple myeloma' (SMM), where the cancer is present but not yet causing major problems. This study is exploring if treating SMM early can stop it from becoming more severe.

The researchers are testing a combination of medicines: Kyprolis, Revlimid, and Dexamethasone. They want to see if these treatments can help participants achieve something called 'MRD negativity.' This means that the amount of cancer cells in their body is so low that standard tests can no longer detect them. Achieving MRD negativity is often a good sign, as it suggests the treatment has been very effective in reducing the cancer.

This is a Phase 2 study, which means it’s still in the process of thoroughly checking if these new treatments are safe and how well they work. They will also look at how patients respond to the treatment, any side effects they might experience, and the overall difference it makes to their health. The study is open to both people with smoldering multiple myeloma and those who already have active multiple myeloma.

Punti chiave

  • The study is investigating potential new treatments for multiple myeloma.
  • It aims to see if treatment can prevent or better control the cancer.
  • Participants will receive specific medications and have regular check-ups.
  • The main goal is to see if treatments can lead to very low cancer levels (MRD negativity).
  • It includes people with early (smoldering) and active multiple myeloma.
  • Participation will involve monitoring for at least three years.

Chi può essere idoneo?

This study is looking for a wide range of people to take part. Generally, you need to be an adult, 18 years old or older. There is no upper age limit, so older adults can also participate.

Both men and women are welcome to join this research. This helps ensure the study's findings are relevant to everyone who might be affected by multiple myeloma.

The study is specifically for people who have been diagnosed with multiple myeloma. This includes those with 'smoldering multiple myeloma' (an early form of the disease) and those with 'active multiple myeloma' (where the disease is more advanced). Your doctor would be able to tell you if you fit into one of these groups.

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. Hai 18 anni o più?
  2. Have you been diagnosed with multiple myeloma (either smoldering or active)?
  3. Sei in grado di partecipare a appuntamenti clinici regolari?
  4. Are you willing to take the study medications as prescribed?
  5. Do you understand that there will be various tests and check-ups during 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'll be given a combination of medications: Kyprolis, Revlimid, and Dexamethasone. These will be given in different ways – Kyprolis as an infusion (into a vein), and Revlimid and Dexamethasone as tablets you swallow. You will have regular visits to the clinic for these treatments and to have check-ups.

During your time in the study, you'll have various tests and assessments. These are important for the research team to monitor how you're responding to the treatment and to keep an eye on your overall health. This will include blood tests and other examinations to check your progress and look for any side effects.

The main goal is to see if the treatment leads to 'MRD negativity' – meaning very few or no cancer cells detectable – three years after you start the study. So, the total duration for monitoring this key outcome is at least three years, with ongoing follow-up after that.

Rischi e benefici potenziali

Taking part in a study like this could offer potential benefits, such as access to new treatments that might be more effective than standard options, especially if you have an early form of the disease. However, there are also potential risks involved. The medications used can have side effects, which the study team will carefully monitor. You will be told about all known side effects before you decide to take part. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Luoghi (1)

Alcune posizioni dei siti sono approssimative. Stiamo migliorando questo — si prega di verificare con il team di prova prima di viaggiare.
  • —
    Non verificato
    Islanda

Domande comuni

What is multiple myeloma?

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

What does 'smoldering multiple myeloma' (SMM) mean?

SMM is an early form of multiple myeloma where cancer cells are present but not yet causing symptoms or major health problems.

What is MRD negativity?

MRD negativity means that the amount of cancer cells in your body is so low that they cannot be detected by standard laboratory tests. It's often a good sign for treatment success.

Are the study medications new?

The medications Kyprolis, Revlimid, and Dexamethasone are typically used for multiple myeloma, but this study is looking at their use in specific situations, especially in early disease.

Dovrò pagare per partecipare allo studio?

No, you will not have to pay for the study medications or the extra appointments and tests that are part of the research.

Come saperne di più

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

Discussione

Discussione della comunità

Supportato dal nostro forum su community.patient.info. Si prega di essere rispettosi — questo non è un consiglio medico.