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AuthorisedTherapeutic exploratory (Phase II)Interventional

A multi-center open-label phase 2 study of Ixazomib, Iberdomide and dexamethasone in elderly patients with multiple myeloma at first relapse

This study is testing a new treatment combination for older patients with multiple myeloma, a type of blood cancer, when their disease returns after initial treatment. The medicines involved are Ixazomib, Iberdomide, and Dexamethasone. The main goal is to see how many patients respond very well to this new combination. Researchers will also be looking at other important aspects, such as side effects, how long patients respond to the treatment, and how long they live. This is a Phase 2 study, meaning it's still in the earlier stages of figuring out the best way to use these drugs together for this group of patients.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
Centre Hospitalier Universitaire De Nantes
Enrolment target
80
Start
05 Nov 2024

What is this study about?

This clinical trial is designed for older people who have multiple myeloma, a type of blood cancer, and whose disease has returned after they've already had some treatment. It's investigating a new combination of three medications: Ixazomib, Iberdomide, and Dexamethasone. You might have heard of Dexamethasone as a steroid often used in cancer treatment.

The main purpose of this study is to see how effective this new combination of drugs is at getting a good response from the multiple myeloma. A "good response" means the treatment significantly reduces the amount of cancer in the body. Researchers will also be keeping a close eye on any side effects to understand how safe the treatment is. Other things they'll measure include how long people stay well on the treatment and how it affects their overall quality of life.

This is a "Phase 2" study, which means it's an important step in researching new treatments. It's not the very first time these drugs have been used, but it's about seeing how well they work together in this specific group of patients before potentially moving on to larger studies.

Key takeaways

  • Tests a new drug combination (Ixazomib, Iberdomide, Dexamethasone) for multiple myeloma.
  • Specifically for older patients whose myeloma has returned after first treatment.
  • Aims to see how effectively the combination controls the disease.
  • Will closely monitor safety and side effects.
  • Also looking at how treatment affects quality of life.
  • This is a Phase 2 study, part of the process of finding better treatments.

Who may be eligible?

This study is particularly for older adults who have multiple myeloma that has come back after their first round of treatment. Being "older" isn't defined by a strict age number in this particular study, but the focus is on the needs of elderly patients.

To be considered for this study, your doctor will need to check various aspects of your health and your specific type of multiple myeloma. This ensures that the study is safe and appropriate for you, and that the results will be meaningful for future patients.

If you're interested, your medical team will compare your health records and your specific condition against a detailed list of requirements. This helps determine if this study is the right option for you.

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.

  1. Are you an older adult?
  2. Have you been diagnosed with multiple myeloma?
  3. Has your multiple myeloma come back after your first treatment?
  4. Are you willing to take new study medications?
  5. Are you able to attend regular clinic appointments for monitoring?
  6. Are you based in the UK and able to participate at a study site?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medications: Ixazomib, Iberdomide (at one of a few possible dose levels), and Dexamethasone. Your treatment will involve regular visits to the clinic for medical checks, blood tests, and to receive your medication. During these visits, the study team will closely monitor your general health and how your multiple myeloma is responding to the treatment.

To understand the treatment's effect, you'll have various assessments, including blood tests and potentially bone marrow samples, at specific times. These tests help determine if the cancer is responding, how long the response lasts, and if there are any side effects. You'll also be asked to complete questionnaires about your quality of life, which helps understand how the treatment affects your daily living.

The total duration of your participation will depend on how you respond to the treatment and the study's requirements, but there will be ongoing follow-up to monitor your health even after treatment, if applicable.

Potential risks and benefits

Taking part in this study could potentially offer a new treatment option for your multiple myeloma. It might help control your disease when other standard treatments may no longer be as effective. However, like all medications, the drugs used in this study can have side effects. The research team will carefully monitor you for these and provide support. It's important to remember that there's no guarantee the treatment will work for everyone, and it's also possible you could experience side effects without benefit. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    France

Common questions

What is multiple myeloma?

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

What are Ixazomib, Iberdomide, and Dexamethasone?

These are medicines used to treat multiple myeloma. This study is looking at how well they work together as a new combination.

What does 'first relapse' mean?

It means your multiple myeloma has come back after you've already had your first course of treatment for it.

What is a 'Phase 2' study?

A Phase 2 study is an early stage of clinical research where doctors test a new treatment to see how well it works and to further assess its safety in a group of patients.

Will this treatment cure my cancer?

Clinical trials aim to find better ways to treat cancer, but this study specifically focuses on controlling multiple myeloma that has relapsed, not necessarily curing it.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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