AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Multicenter, Randomized, Controlled, Open-label, Group-Sequential, Phase 3 Study to Investigate the Efficacy, Safety, and Tolerability of Intravenous Gammagard Liquid (Immune Globulin Infusion, 10%) for Primary Infection Prophylaxis Compared With Secondary Infection Prophylaxis in Adult Subjects With Multiple Myeloma Receiving B-Cell Maturation Antigen×CD3–Directed Bispecific Antibody Therapy

This study is investigating a medication called Gammagard Liquid (also known as KIOVIG), which is a type of immune globulin. It's for adults who have multiple myeloma, a blood cancer, and are also being treated with a newer type of drug that works on specific cells. The main goal is to find out if giving Gammagard Liquid early on can prevent serious infections better than waiting until infections might become a problem. We want to see how well it works and if it's safe and tolerable for patients. This is an important Phase 3 study, meaning it's a large trial to confirm the benefits of the treatment.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Takeda Development Center Americas Inc.

Enrolment target

172

Start

25 Aug 2025

Primary infection prophylaxis for secondary immunodeficiency (SID) in patients with multiple myeloma (MM) receiving B cell maturation antigen (BCMA)-directed bispecific (BsAb) therapy

What is this study about?

When you have multiple myeloma, a type of blood cancer, and are receiving certain new treatments, your immune system can become weaker. This means you might be more prone to getting serious infections, which can be very serious for your health.

This study is looking at a medicine called Gammagard Liquid (also known as KIOVIG). This medicine helps to boost your body's natural defences against infections. Doctors are trying to understand the best way to use this protective medicine. Should it be given to you right away to try and prevent infections from happening at all (this is called 'primary prevention')? Or is it better to wait and give it only if there are signs that you might be at high risk for infection (this is called 'secondary prevention')?

The main aim of this study is to compare these two approaches. Researchers will be carefully checking to see if patients who receive Gammagard Liquid early on experience their first serious infection later, or if they avoid serious infections altogether, compared to those who receive it later. They will also be looking at how many infections people get, how much antibiotic medicine they need, and if the Gammagard Liquid is safe and well-tolerated by patients.

Key takeaways

This study compares two ways of preventing infections in multiple myeloma patients.
It uses a medicine called Gammagard Liquid to boost the immune system.
The goal is to see if early prevention of infections is better than prevention later on.
It's a large, important study (Phase 3) to confirm treatment benefits.
Participation involves regular checks and monitoring for 12 months.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. Both men and women can participate.

Crucially, you must have multiple myeloma and be receiving a specific, newer type of treatment for it. This new treatment targets certain cells in your body to fight the cancer. The study is designed for people who are at risk of developing infections because of their multiple myeloma and its treatment.

There will be other, more detailed criteria that your doctor will check to make sure the study is a good fit for you and that it's safe for you to take part. These might include things like your overall health, other medicines you are taking, and specific blood test results.

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?
Are you currently receiving a specific new type of treatment for your multiple myeloma?
Are you able to have regular clinic visits and blood tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive Gammagard Liquid through a drip into your vein (intravenously). The study will compare two different ways of giving this medicine to protect you from infections. You might be given Gammagard Liquid from the beginning of your treatment (primary prevention), or you might receive it only if specific signs suggest you need it later on (secondary prevention).

Participation will involve regular visits to the clinic for assessments. These will include physical examinations, blood tests, and discussions about how you are feeling and any infections you may have. Researchers will track how long it takes for any serious infections to occur, if they do, over a period of 12 months. The total duration of the study will involve these regular checks and follow-up to monitor your health and the effects of the treatment.

Potential risks and benefits

Taking part in this study could offer the potential benefit of better protection against serious infections, which could improve your health and quality of life while undergoing treatment for multiple myeloma. However, like all medicines, Gammagard Liquid can have side effects. You might experience reactions during or after the infusion, such as headaches, fever, or mild allergic reactions. Your healthcare team will carefully monitor you for any side effects and manage them if they occur. You are always in control and can decide to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

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

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Unverified
Hungary
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Unverified
Germany
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Unverified
Greece
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Unverified
Netherlands
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Unverified
Austria
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Unverified
Poland
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Unverified
Italy
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Unverified
Czechia
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Unverified
Spain
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Unverified
Denmark
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Unverified
Romania
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Unverified
Norway

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. These cells help your body fight infections.

What is Gammagard Liquid (or KIOVIG)?

Gammagard Liquid is a medicine made from human blood products. It contains antibodies that help your immune system fight off infections. It's given through a drip into your vein.

Why is this study important for people with multiple myeloma?

People with multiple myeloma, especially those on certain treatments, can have a weakened immune system. This study aims to find the best way to prevent serious infections, which can be a major challenge for these patients.

Will I know if I'm getting the early prevention or later prevention?

This study is 'open-label,' which means both you and your study doctor will know which way of prevention you are receiving.

How long will the study follow me for?

Researchers will be keeping a close eye on you for any serious infections for about 12 months after you start the study treatment.