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Study on Human Normal Immunoglobulin to Prevent Early Infections in Patients with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a disease called Multiple Myeloma, which is a type of cancer that affects the blood. The treatment being tested in this study is called HyQvia, which is a solution containing human normal immunoglobulin. This solution is given through an injection under the skin, known as a subcutaneous injection. The purpose of the study is to see if using HyQvia can help reduce the number of infections and early deaths in patients who have recently been diagnosed with multiple myeloma and are not eligible for certain intensive treatments like stem cell transplants.

Participants in the study will receive either HyQvia or a standard treatment, which may include a placebo. The study will last for about a year, during which time researchers will monitor the participants to see how many severe infections occur. Severe infections are those that are more serious and require medical attention. The study will also look at other factors, such as how long participants need to take antibiotics or other medications to treat infections, how often they need to be hospitalized due to infections, and their overall survival rates at six and twelve months after starting the study.

Throughout the study, researchers will also collect information on various aspects of the participants' health, such as their levels of certain antibodies in the blood, which help fight infections, and their quality of life. This information will help determine how effective HyQvia is in preventing infections in people with multiple myeloma. The study aims to provide valuable insights into improving care for patients with this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of multiple myeloma, and certain health conditions.
Informed consent is required, ensuring understanding of the study's purpose and procedures.
Step 2
Treatment initiation
The treatment involves the administration of HyQvia, a solution for infusion containing human normal immunoglobulin.
The medication is given through a subcutaneous injection, which means it is injected under the skin.
Step 3
Treatment schedule
The frequency and dosage of HyQvia are determined by the study protocol and the healthcare provider overseeing the treatment.
Regular monitoring is conducted to assess the response to the treatment and adjust the dosage if necessary.
Step 4
Monitoring and assessments
Throughout the study, regular assessments are performed to monitor health status and the occurrence of any infections.
Blood tests are conducted to measure IgG levels and other relevant health indicators.
Step 5
Follow-up and data collection
Follow-up visits are scheduled to collect data on health outcomes, including the number and severity of infections.
Patient-reported outcomes on health-related quality of life are also gathered during these visits.
Step 6
Study completion
The study is expected to conclude by June 2026, with final assessments and data analysis conducted at that time.
Participants are informed of the study results and any implications for their ongoing care.

Who can join the trial?

5 criteria

Must be **18 years or older**.
Must be able to **give informed consent**, which means understanding the study and agreeing to participate.
Must have **newly diagnosed multiple myeloma**, a type of blood cancer, and meet specific criteria known as **CRAB criteria** or have a **biomarker for malignancy**. CRAB criteria refer to certain symptoms or lab results that indicate the disease.
Must be **ineligible for high-dose melphalan** with **autologous stem cell transplantation**, which is a type of treatment involving high-dose chemotherapy and stem cell transplant.
Must have **hypogammaglobulinemia**, which means having low levels of certain proteins in the blood called **immunoglobulins**. Specifically, the levels should be below: IgG: 6 g/L, IgA: 0.7 g/L, IgM: 0.4 g/L.

Who cannot join the trial?

13 criteria

Patients who have had a previous organ transplant.
Patients with a history of severe allergic reactions to medications.
Patients who are currently participating in another clinical trial.
Patients with uncontrolled high blood pressure. This means their blood pressure is not being managed well with treatment.
Patients with active infections that require treatment with antibiotics.
Patients with a history of cancer other than multiple myeloma, unless they have been cancer-free for at least 5 years.
Patients with severe heart disease. This includes conditions like heart failure, where the heart doesn't pump blood as well as it should.
Patients with severe liver disease. This means the liver is not working properly.
Patients with severe kidney disease. This means the kidneys are not working properly.
Patients who are pregnant or breastfeeding.
Patients who have a mental health condition that would make it difficult to follow the study procedures.
Patients who have a substance abuse problem, such as alcohol or drug addiction.
Patients who are unable to give informed consent. This means they cannot understand the study and agree to participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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North Estonia Medical Centre Foundation
Tallin, Estonia
Verified
Odense University Hospital
Odense, Denmark
Verified
Oslo Universitetssykehus HF
Oslo, Norway

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Investigated drugs

HyQvia is a medication used in this clinical trial. It is a type of immunoglobulin therapy given under the skin (subcutaneously) to help prevent infections. In this study, it is being tested to see if it can reduce the number of infections and early deaths in patients with newly diagnosed multiple myeloma who are not eligible for a transplant. The goal is to see if using HyQvia as a preventive treatment can be more effective than the standard care currently provided.

Human Normal Immunoglobulin

What is already known about the treatment

HyQvia – HyQvia is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness in reducing infections in patients with multiple myeloma who are not eligible for transplants. The main therapeutic indication for HyQvia is to provide immunoglobulin prophylaxis, which helps prevent infections. At the molecular level, HyQvia works by supplying antibodies that the body needs to fight off infections, thereby boosting the immune system. It is classified pharmacologically as an immunoglobulin therapy.

Investigated diseases

Multiple Myeloma – Multiple myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. These cells become abnormal and multiply uncontrollably, leading to the production of abnormal proteins that can cause damage to bones and other organs. As the disease progresses, it can lead to bone pain, fractures, anemia, kidney dysfunction, and increased susceptibility to infections. The accumulation of abnormal plasma cells can also crowd out healthy blood cells, leading to fatigue and other symptoms. Over time, the disease can cause significant complications due to the impact on the body's ability to produce normal blood cells and maintain bone health.