Active not recruitingOBSERVATIONAL

Selinexor (Nexpovio®) (SVd) in Patients With Relapsed or Refractory Multiple Myeloma

This study, called SEATTLE, is for people in the UK who have multiple myeloma, a type of blood cancer, that has either returned after treatment or hasn't responded to past medicines. The study focuses on a drug called selinexor (Nexpovio®), which is often given with other medicines like bortezomib and dexamethasone. We want to understand what it's like for patients taking this treatment in their daily lives. This includes looking at their quality of life, how well they tolerate the medication, any side effects they experience, and how effective the treatment is. By gathering this real-world information, we hope to get a better picture of how selinexor helps patients and how it's best used, adding to what we already know from previous research.

At a glance

Status

Active not recruiting

Sponsor

iOMEDICO AG

Enrolment target

Start

28 Jun 2023

Estimated completion

30 Oct 2026

Multiple Myeloma

What is this study about?

This study is looking at a specific medicine called selinexor (you might also hear it called Nexpovio®) for people in the UK who have a type of blood cancer called multiple myeloma. Multiple myeloma affects cells in your bone marrow. Sometimes, this cancer can come back after treatment, or it might not respond well to earlier medicines. In these situations, doctors look for other ways to help.

Selinexor is a treatment that works by stopping cancer cells from growing and encouraging them to die off. It's often given along with two other medicines, bortezomib and dexamethasone. We already have information about how selinexor works from earlier research studies. However, this study, called SEATTLE, is designed to see what happens when patients use selinexor in their regular daily lives, outside of a special research environment. We want to understand how it affects their quality of life, how easy it is to manage any side effects, and how well it works for different people.

The main goal is to get a clearer picture of how patients experience this treatment in their everyday healthcare. This includes understanding the best way to give the medicine and how it helps people feel. This type of 'real-world' information is very important because it helps doctors and patients make the best choices about treatments for multiple myeloma.

Key takeaways

This study evaluates selinexor (Nexpovio®) for multiple myeloma.
It's for people whose cancer has returned or didn't respond to previous treatments.
The study gathers 'real-world' information on how patients experience the treatment.
It looks at quality of life, side effects, and how well the treatment works.
Participation involves answering questions about your health and treatment experience.
This is not a trial testing a new drug; you receive standard care.

Who may be eligible?

To be part of this study, you need to be an adult, at least 18 years old, and have multiple myeloma that has either returned or hasn't responded to previous treatments. Your doctor must have decided that selinexor, in combination with bortezomib and dexamethasone, is the right next treatment step for you, as your second treatment line or later.

It's important that this decision about your treatment is made before you formally join the study. You also need to be willing and able to use an electronic device, like a tablet or smartphone, to answer some questions about how you're feeling and your experiences with the treatment. You'll also need to sign a consent form, which explains everything about the study in detail, before you start.

You cannot join this study if you are already taking part in another clinical trial where doctors are trying out new medicines or treatments. Also, if there are specific medical reasons why selinexor is not suitable for you, as outlined in the medicine's official information, then you won't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have multiple myeloma that has come back or hasn't responded to previous treatments?
Has your doctor decided that selinexor, along with bortezomib and dexamethasone, is your next appropriate treatment (2nd line or later)?
Are you able and willing to answer health questions using an electronic device?
Are you not currently participating in another clinical trial where a new treatment is being tested?

Answer every question to see your result.

What does participation involve?

This study is 'non-interventional,' which means you'll be receiving selinexor as part of your standard medical care, just as your doctor would prescribe it normally. You won't be asked to do anything extra beyond your usual doctor's appointments and treatments. The main part of participating involves answering questions about your quality of life, how you're feeling, and any side effects you might experience. These questions will be given to you through an electronic device (ePRO module). The study will follow your progress while you are receiving selinexor as prescribed by your doctor. There are no additional study visits or medications beyond what your doctor already planned for your treatment.

Potential risks and benefits

The potential benefit of participating in this study is helping researchers and doctors understand more about how selinexor works for patients with multiple myeloma in everyday life. This knowledge can help improve future care for others. Since you're receiving standard treatment, your potential risks are primarily those associated with selinexor and your overall condition, as discussed with your doctor. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (2)

Medizinische Universität Wien, Universitätsklinik für Innere Medizin I
Verified postcode
Vienna, Austria
Gemeinschaftspraxis für Hämatologie und Onkologie GbR
Verified postcode
Ravensburg, Germany

Common questions

What is multiple myeloma?

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

What is selinexor (Nexpovio®)?

Selinexor is a medicine used to treat multiple myeloma. It works by stopping cancer cells from growing and helping them to die.

What does 'relapsed or refractory' mean?

It means your multiple myeloma has either come back after previous treatment (relapsed) or it hasn't responded well to earlier treatments (refractory).

Will I get extra medicine or different care in this study?

No, you will receive your selinexor treatment exactly as your doctor normally prescribes it. This study just collects information about how you're doing.

What is 'quality of life' in this study?

Quality of life refers to how you feel about your well-being, your daily activities, and how your treatment impacts your overall happiness and comfort.