Study of human normal immunoglobulin and teclistamab for infection prevention in adults with multiple myeloma receiving B-cell maturation antigen therapy

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What is this study about?

This study focuses on patients with Multiple Myeloma who are receiving treatment with teclistamab, a medication that targets specific proteins on cancer cells. The study aims to evaluate whether giving preventive treatment with immune globulin infusion (a solution containing antibodies) early in the course of cancer therapy is more effective than waiting to give it only after infections occur.

The treatment involves two medications: TECVAYLI (teclistamab), which is given as an injection under the skin, and KIOVIG, which is given through an intravenous infusion. TECVAYLI is a specialized antibody that helps the immune system fight cancer cells, while KIOVIG contains antibodies that help prevent infections in patients whose immune systems are weakened by cancer treatment.

During the study, patients will receive their regular cancer treatment with TECVAYLI and will be divided into two groups. One group will receive KIOVIG preventively from the start of their cancer treatment, while the other group will only receive KIOVIG if they develop infections. The study will track how well these different approaches work in preventing serious infections over a period of 12 months.

1 Initial eligibility verification

Your diagnosis of multiple myeloma (MM) will be verified according to international guidelines

You must have started teclistamab treatment within the past 8 weeks

You must be at least 18 years old

2 Treatment assignment

You will be randomly assigned to one of two groups:

Group 1: Receiving primary infection prevention treatment

Group 2: Receiving secondary infection prevention treatment

The treatment will involve immune globulin infusion (10%) administered through intravenous infusion

3 Treatment period

Your treatment will continue for 12 months

During this time, you will receive regular doses of teclistamab through subcutaneous injection

You will also receive immune globulin through intravenous infusion according to your assigned group

4 Monitoring period

Your health will be monitored for:

Any serious infections that may occur

Use of antibiotics for bacterial infections

Number of bacterial infections experienced

5 Study completion

The study will end after 12 months of observation

A follow-up period of 30 days after the last dose will be required

If you are of childbearing potential, you must continue using effective contraception during this period

Who Can Join the Study?

  • You must have been diagnosed with multiple myeloma (MM), which is a type of blood cancer that affects plasma cells in the bone marrow. This diagnosis must be confirmed according to international guidelines.
  • You must have recently started treatment with teclistamab (within the first 8 weeks) and plan to continue this treatment for the next 12 months.
  • You must be at least 18 years old when signing the consent form.
  • You must be willing and able to provide written informed consent to participate in the study.
  • If you can become pregnant and are sexually active, you must:
    • Use highly effective birth control methods during the study and for 30 days after the last dose of study medication
    • Agree not to donate eggs during this period

Who Cannot Join the Study?

  • Age below 18 years old
  • Known allergies or severe reactions to immunoglobulin products (antibody-based medications)
  • Active severe infections requiring immediate treatment
  • History of thrombotic events (blood clots) in the past 6 months
  • Severe kidney problems or kidney failure requiring dialysis
  • Currently participating in other clinical trials
  • Pregnancy or breastfeeding
  • Severe liver disease
  • IgA deficiency (lack of a specific type of antibody) with antibodies against IgA
  • Mental conditions that prevent understanding of the study requirements
  • Life expectancy less than 6 months
  • History of severe allergic reactions to blood products
  • Uncontrolled high blood pressure
  • Serious heart conditions
  • Active bleeding disorders

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Salamanca Salamanca Spain
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Hospital Universitario 12 De Octubre Madrid Spain
St. Olavs Hospital HF Trondheim Norway
Azienda Sanitaria Locale Di Pescara Pescara Italy
University Of Debrecen Debrecen Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
Institutul Clinic Fundeni Bucharest Romania
University Teaching Hospital Markusovszky Szombathely Hungary
Spitalul Clinic Coltea Bucharest Romania
Spitalul Clinic Colentina Bucuresti Bucharest Romania
University General Hospital Of Ioannina Ioannina Greece
Odense University Hospital Odense Denmark
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Alexandra Hospital Athens Greece
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Universita’ Politecnica Delle Marche Ancona Italy
Aalborg University Hospital Aalborg Denmark
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Region Midtjylland Aarhus Denmark
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Rigshospitalet Copenhagen Denmark
Servei De Salut De Les Illes Balears Palma Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hospital Costa del Sol Marbella Spain
University Hospital Ostrava Ostrava Czechia
Uqanzththyrthhfkxjiwu Eaujy Anc Essen Germany
Olhvhmidaslebn Ljzf Gtmv Linz Austria
Sfcqpkdh Cuhjaa Mylcognyf Ffqapobqkbo Cmhbujj Craiova Romania
Hgaql Nbumfrlxfnzkhc Hl Levanger Norway
Aibpmns Sfr z onke Poznan Poland
Uxagpjqjyw Hatemnmy Cxevopq Cologne Germany
Ainruuyjg Uad Amsterdam The Netherlands
Ajppejsd Urtfwybtbo Hszdnelz Lorenskog Norway
Uspgjasgrqrtos Cexwhog Kkrwmnxiy Gdansk Poland
Uzvpwmjizp Dbbcy Sgoqw Dy Rhpq La Sczktrtc Rome Italy
Fturmobtk Pelo Ln Ixitnphosvwia Btfidwcdg Dit Hjyayntd Uoojnjjbtrtvp Ln Pxs Madrid Spain
Kykrezh Dms Boezfryvzmdy Bjmrvdb Linz Austria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
01.09.2025
Czechia Czechia
Not yet recruiting
01.09.2025
Denmark Denmark
Not yet recruiting
01.09.2025
Germany Germany
Not yet recruiting
01.09.2025
Greece Greece
Not yet recruiting
01.09.2025
Hungary Hungary
Not yet recruiting
01.09.2025
Italy Italy
Not yet recruiting
01.09.2025
Norway Norway
Not yet recruiting
01.09.2025
Poland Poland
Not yet recruiting
01.09.2025
Romania Romania
Not yet recruiting
01.09.2025
Spain Spain
Not yet recruiting
01.09.2025
The Netherlands The Netherlands
Not yet recruiting
01.09.2025

Trial locations

Gammagard Liquid (Immune Globulin Infusion) is a medication made from human plasma that contains antibodies. It helps strengthen the immune system to fight infections. In this trial, it is given intravenously to protect multiple myeloma patients from infections while they receive cancer therapy. The medication is commonly used to treat various immune deficiency conditions and is being tested here as a preventive treatment.

B-Cell Maturation Antigen×CD3 Bispecific Antibody is a type of cancer therapy that helps the immune system fight multiple myeloma cells. This antibody therapy works by connecting immune cells (T-cells) to cancer cells, enabling the immune system to better recognize and destroy the cancer cells. It’s a targeted therapy specifically designed for multiple myeloma treatment.

Multiple Myeloma – A type of blood cancer that develops in plasma cells, which are white blood cells that help fight infections. In this condition, cancerous plasma cells accumulate in the bone marrow and crowd out healthy blood cells. These abnormal cells produce large amounts of defective antibodies that can build up in the body. The disease can weaken bones and affect the body’s ability to fight infections. Multiple myeloma often develops gradually and can affect various parts of the body.

Secondary Immunodeficiency – A condition where the immune system becomes weakened due to an outside cause, such as disease or medical treatment. This condition develops after birth and results in decreased ability to fight infections. The immune system’s capacity to protect against harmful organisms becomes compromised, making the person more susceptible to various infections. Secondary immunodeficiency can occur as a consequence of other medical conditions or treatments.

Trial ID:
2024-518420-80-00
Protocol code:
TAK-339-3001
Trial Phase:
Therapeutic confirmatory (Phase III)

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