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RekrutierungTherapeutische Erkundung (Phase II)Interventionell

Subcutaneous immunoglobulin (HyQvia) against early infections in multiple myeloma: SHIELD

Multiple myeloma is a type of blood cancer that weakens your body's immune system, making it harder to fight off bugs. People with myeloma are at high risk of getting serious chest, viral, or bacterial infections, particularly in the first year after diagnosis. This trial is testing a medicine called HyQvia. It contains normal, healthy antibodies (proteins that fight illness) and is given as an injection under the skin. Researchers want to find out if giving HyQvia regularly can prevent severe infections, cut down on hospital stays, and reduce the number of antibiotics people need. The trial is open to adults of any age with multiple myeloma. If you join, doctors will monitor your health, take blood tests, and track any illnesses for up to a year to see how well the treatment protects you.

Auf einen Blick

Status
Rekrutierung
Phase
Therapeutische Erkundung (Phase II)
Sponsor
Lillebaelt Hospital
Einschreibeziel
100
Starten
08 Sep 2023

Worum geht es in dieser Studie?

Multiple myeloma is a cancer that develops in plasma cells, which are a vital part of your immune system. Healthy plasma cells normally make antibodies that protect you from coughs, colds, and severe bugs. When you have myeloma, your body cannot produce enough working antibodies. Because of this, infections are very common and can sometimes become serious enough to need hospital treatment, especially early on in your care.

The SHIELD study is looking at whether boosting the body's defences can keep patients safer and healthier. Researchers are testing a treatment called HyQvia. HyQvia provides natural antibodies collected from healthy blood donors. It is given as a slow injection just under the skin (subcutaneous infusion), which allows the body to absorb it gradually.

During this trial, doctors will track how many infections participants get over a 12-month period. They will also look at whether the treatment cuts down the days people spend in hospital, reduces the need for strong antibiotics, and improves daily quality of life. The ultimate aim is to find out if this simple immune boost can help people with myeloma stay well while having their cancer treatment.

Wichtige Erkenntnisse

  • The SHIELD study tests whether HyQvia can prevent serious infections in people with multiple myeloma.
  • HyQvia is an antibody treatment given as an injection under the skin.
  • The trial measures hospital visits, antibiotic use, and infection rates over 12 months.
  • It is open to adults aged 18 and over with multiple myeloma.
  • Participation is voluntary and will not interrupt your main cancer therapy.

Wer könnte berechtigt sein?

This trial is designed for adults who have been diagnosed with multiple myeloma and are at risk of developing infections. It is open to both men and women aged 18 and older.

To take part, your medical team will check your overall health and review what stage your myeloma is at. They will also look at your current cancer treatments and check your natural antibody levels using simple blood tests to see if this study is suitable for you.

You might not be able to join if you have had severe allergic reactions to antibody products in the past, or if you have specific medical conditions that make subcutaneous infusions unsafe. Your doctor or research nurse can review your full medical history to tell you for sure.

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

  1. I am aged 18 or older.
  2. I have been diagnosed with multiple myeloma.
  3. I am able to attend regular hospital visits for blood tests and monitoring.
  4. I have not had a severe allergic reaction to antibody therapies in the past.
  5. I am happy to receive regular injections just under the skin.
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

Taking part in the study lasts for about 12 months. During this time, you will receive regular doses of HyQvia as a slow injection under the skin, usually in your tummy or thigh. A trained nurse will show you how this works, and it may be possible to receive these at home or at your local hospital clinic.

You will attend routine hospital check-ups where the research team will take blood samples to measure your antibody levels and immune cells. You will also be asked to keep track of any illnesses, fevers, or antibiotics you take.

The team will monitor you closely throughout the year. They will also ask you to fill in short questionnaires about how you are feeling and your overall quality of life, to ensure the treatment is not causing too much disruption to your daily routine.

Potenzielle Risiken und Vorteile

Taking part may give your immune system an extra shield, potentially lowering your risk of serious infections and hospital visits, though this cannot be guaranteed. Like all medications, HyQvia can cause side effects. Common ones include mild swelling, redness, or itching where the needle goes in, as well as temporary headache, fever, or tiredness. Serious allergic reactions are rare, but the team will watch you carefully. Joining the study is completely voluntary; you can leave at any point without your standard NHS cancer care being affected in any way.

Standorte (3)

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    Norwegen
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    Estland

Häufige Fragen

What is HyQvia?

HyQvia is a medicine made of healthy human antibodies. It helps replace the infection-fighting proteins that your body is currently struggling to make.

Wie wird das Medikament verabreicht?

It is given as a liquid infusion through a tiny needle placed just under the skin, usually in the abdomen or thigh, rather than directly into a vein.

Will this cure my multiple myeloma?

No. HyQvia is not a cure for myeloma. It is designed to protect you from dangerous infections while you receive your standard myeloma treatments.

Does taking part cost anything?

No, the trial medication and all study-related tests are provided free of charge through the clinical trial.

Can I carry on with my normal cancer treatment?

Yes. This study is meant to support you alongside your regular myeloma care, but your doctor will confirm that all your medicines work safely together.

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