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RecruitingPHASE4INTERVENTIONAL

Immunoglobulins in Multiple Myeloma Patients Receiving a BCMA-Directed T Cell Engager

New treatments for multiple myeloma, called BCMA-directed T-cell engagers, can be very effective but can also make patients more likely to get serious infections. This is because these treatments can weaken the immune system even further. We know that giving extra proteins called immunoglobulins can help fight infections in some patients. This study wants to find out the best amount of immunoglobulin to give to patients receiving these new treatments. It will compare two different target levels of immunoglobulins in the blood to see which one works best at preventing severe infections over three months, especially in patients who have relapsed or their myeloma is not responding to other treatments.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
CHU de Quebec-Universite Laval
Enrolment target
80
Start
05 Jan 2026
Estimated completion
01 Dec 2029

What is this study about?

This study is about people who have multiple myeloma, a type of blood cancer, especially those whose cancer has come back (relapsed) or is no longer responding to standard treatments. There are some exciting new treatments called BCMA-directed T-cell engagers that are helping many patients. However, a common problem with these new treatments is that they can make your immune system weaker, which means you are more likely to get infections. Patients with multiple myeloma often already have a weaker immune system, so these new drugs can make this situation even more challenging.

To help prevent severe infections, doctors sometimes give patients extra proteins called immunoglobulins, which are a key part of your immune system. While we know immunoglobulins can be helpful, we're not entirely sure if everyone receiving these new BCMA-directed treatments needs them, or what the ideal amount of immunoglobulin in the blood should be to offer the best protection against infections. This study aims to answer those important questions.

The main goal of this research is to compare two different target levels of immunoglobulins in the blood to find out which one is better at preventing severe infections after three months. One group of patients will aim for a lower target level (4-6 g/L) and another group will aim for a higher target level (8-10 g/L). By understanding this, doctors will have better guidance on how to support patients and reduce their risk of serious infections while they are on these powerful new myeloma treatments.

Key takeaways

  • This study aims to prevent infections in multiple myeloma patients.
  • It focuses on patients receiving new BCMA-directed T-cell engager treatments.
  • The study compares two different target levels for immunoglobulin support.
  • The goal is to find the best way to reduce severe infections.
  • Participation involves regular monitoring and immunoglobulin adjustments.
  • It helps doctors give better care for patients on these new therapies.

Who may be eligible?

This study is looking for adults aged 18 or older who have multiple myeloma.

You would be eligible if your multiple myeloma has not responded well to at least one previous treatment, and you are starting a new treatment called a BCMA-directed T-cell engager. This study is open to both men and women, and it doesn't matter if you have received immunoglobulin support before or not.

You would not be able to join if you are under 18 years old, or if you are pregnant or breastfeeding.

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 18 years old or older?
  2. Do you have multiple myeloma that has come back or isn't responding to treatment?
  3. Are you about to start a new BCMA-directed T-cell engager treatment?
  4. Are you not pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups. Both groups will receive immunoglobulin support, but the goal will be to maintain your immunoglobulin levels within a specific range. One group will aim for a lower target level (4-6 g/L) and the other will aim for a higher target level (8-10 g/L).

You will have regular blood tests to check your immunoglobulin levels and your medical team will adjust your immunoglobulin doses as needed to keep you in your target range. Your doctors will also carefully monitor you for any infections. The main part of the study will last for three months, during which your doctors will be looking at how many severe infections occur in each group.

Potential risks and benefits

Taking part in this study might offer you the potential benefit of receiving careful and personalised immunoglobulin support, which could help reduce your risk of infections while on your new myeloma treatment. However, there are no guarantees, and we are still learning which approach is best. Potential risks include those associated with receiving immunoglobulin infusions, such as allergic reactions, and the usual risks of blood tests. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Centre Intégré de Cancérologie
    Verified postcode
    Québec, Canada· Recruiting

Common questions

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 are BCMA-directed T-cell engagers?

These are new medicines that help your body's own immune cells (T-cells) find and kill the myeloma cells. They are a type of targeted therapy.

Why would I need immunoglobulin support?

New myeloma treatments, while effective, can sometimes weaken your immune system further, making you more prone to infections. Immunoglobulins are proteins that help your body fight these infections.

What does 'relapsed refractory' mean?

It means your multiple myeloma has come back after treatment (relapsed) or it is no longer responding to other treatments (refractory).

Will I know which immunoglobulin level I'm aiming for?

This study is 'unblinded,' which means both you and your doctor will know which target immunoglobulin level you are aiming for.

How to find out more

Philippe Nadeau, PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Immunoglobulins in Multiple Myeloma Patients Receiving a BCM…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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