RecruitingOBSERVATIONAL

Cost-utility Analysis of Ambulatory Dose Escalation of Bispecific Antibodies in Multiple Myeloma.

This study is about a new treatment for people with a type of blood cancer called multiple myeloma, especially when other treatments haven't worked or the cancer has come back. The treatment uses special antibodies to help your body's immune system fight the cancer. We want to see if giving this treatment, which starts with small doses that gradually increase, is better when done at home (outpatient) compared to staying in the hospital. Researchers are looking at how this affects patients' quality of life and the cost to the healthcare system. The goal is to provide high-quality care that's also practical and accessible for everyone.

At a glance

Status

Recruiting

Sponsor

University Hospital, Toulouse

Enrolment target

Start

20 Jan 2025

Estimated completion

31 Dec 2026

Multiple Myeloma in Relapse

What is this study about?

This study is looking into a new and exciting treatment for multiple myeloma, which is a type of cancer that affects a certain kind of white blood cell. When the cancer comes back or doesn't respond to other treatments, these new medicines, called bispecific antibodies, can help. They work by boosting your own immune system to find and destroy the cancer cells. This treatment is given as a series of injections under the skin, starting with small doses that gradually go up over about 10 days, followed by weekly treatments.

The main idea behind this study is to compare two ways of giving this initial, dose-escalation part of the treatment. Some patients might be able to have these first few injections at home, coming to the hospital for appointments, while others might need to stay in the hospital for them. Doctors want to understand if giving the treatment at home is just as safe and effective, and if it affects how you feel and your daily life. They're also looking at the costs involved, because it's important to make sure new treatments are affordable and sustainable for our healthcare system, so that everyone who needs them can get them.

This research is important because it could help more people access this innovative cancer treatment in a way that fits better with their lives, while still getting excellent care. It builds on early findings from a hospital in France that suggest giving the treatment at home could be safe and might not worsen patients' quality of life.

Key takeaways

This study looks at a new immune-boosting treatment for multiple myeloma.
It compares receiving treatment at home vs. in hospital.
The focus is on patient quality of life and costs.
Helps understand if home treatment is safe, effective, and convenient.
Aims to make high-quality care more accessible.
Involves completing questionnaires about your health.

Who may be eligible?

To be part of this study, you need to have multiple myeloma that has either come back after treatment or isn't responding to current treatments. You must be at least 18 years old and be currently receiving one of the specific antibody treatments (teclistamab, elranatamab, or talquetamab).

If you're having the treatment at home, it's important that you're generally feeling well, the cancer isn't getting worse very quickly, you don't have a lot of cancer spread, and you don't have any current infections. You also need to live close enough to the hospital (within 30 minutes' travel) for 48 hours after each dose escalation injection, just in case you need to come in quickly. If these things aren't possible, you'd be treated in the hospital instead.

People who can't understand the study information because of language barriers or difficulty reading would not be able to join. Your doctor will make sure you understand everything about the study before you decide if you want to take part.

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.

Do you have multiple myeloma that has returned or isn't responding to treatment?
Are you currently receiving teclistamab, elranatamab, or talquetamab?
Are you 18 years old or older?
If considering home treatment, are you generally well with stable cancer and no current infection?
For home treatment, do you live within 30 minutes of the hospital during the initial phase?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will continue to receive your bispecific antibody treatment as planned by your medical team. The main difference is that researchers will collect extra information from you. This will involve filling out questionnaires about your quality of life at three different times during the first phase of your treatment where the dose is slowly increased. These questionnaires will ask about your overall health and how your cancer and its treatment affect your daily life. The study will also look at your routine clinical information and any costs related to your hospital visits.

Potential risks and benefits

Participating in this study means your treatment will be carefully monitored, and you'll be contributing valuable information that could help future patients with multiple myeloma. The study itself doesn't change your treatment plan, but it helps doctors understand the best way to deliver care more effectively and comfortably. While the initial findings suggest no increased risk of complications, as with any medical treatment, there can be side effects. The potential benefit is that giving treatment at home could improve your convenience and quality of life. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (1)

CHU de Toulouse
Verified postcode
Toulouse, France· Recruiting

Common questions

What is multiple myeloma?

It's a type of cancer that affects important immune cells in your bone marrow.

What are bispecific antibodies?

These are special medicines that help your immune system fight cancer cells.

What does 'dose escalation' mean?

It means starting with a small dose of medicine and slowly increasing it over time.

Will my treatment change if I join the study?

No, the study mainly involves collecting extra information about your quality of life and care.

Why are they studying this?

To find the best and most practical way to give this new treatment, both for patients and the healthcare system.

How to find out more

Aurore PERROT, Md, PhD

perrot.aurore@iuct-oncopole.fr 0531155050 Official trial record

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