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

Other Sites

Site Name City Country Status
Spitalul Clinic Coltea Bucharest Romania
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
University Hospital Ostrava Ostrava Czechia
Fundeni Clinical Institute Bucharest Romania
Semmelweis University Budapest Hungary
Copernicus Podmiot Leczniczy Sp. z o.o. Gdansk Poland
Arthjtiij Kltqdvfj Hkidwfe Gehl Hamburg Germany
Azpirhm Ojmmjlebqgdfusivdytmrtvhk Pbojqjfwdht Gq Rprfanlvhrdy Myasj Di Cuhsafq Catania Italy
Naq Lje Gpsgbtgehx Rtjqjp Mxvus Gnvi St. Poelten Austria
Uwlkkhfcqlaiblppsoxag Ezxhd Abj Essen Germany
Ohnslnftecxfdv Lzhg Gkaw Linz Austria
Hwbundbg Uvzldjddsmjhj 1d Dk Okyupsd Madrid Spain
Sog Oizqi Hxpjcxoz Hp Trondheim Norway
Agzyytk Sudprgvej Lhiewx De Pjsffja Pescara Italy
Uflnyurcum On Dsjffuig Debrecen Hungary
Saiaux Vuewjakny Kobplf Mrz Oxjpnb Kotccw Kaposvar Hungary
Urivgfsvrz Tlbgknhu Hjwynqfz Mejqnjvqhsvn Szombathely Hungary
Shlmumxn Cpbzuv Cfcgxonaf Bzvslswif Bucharest Romania
Sfpwpjsi Cqywcw Mswbbafzy Fpvzqzsocbp Cyorkxf Craiova Romania
Ujmdehpdkw Gkaovhp Hykepdou Oh Ifqwqvif Ioannina Greece
Hfoua Naswqxdbhjafoc Hg Levanger Norway
Apmjflq Sxc z omoi Poznan Poland
Ubwccidvyh Hzvseiij Ccysnsm Cologne Germany
Oxhtqy Ulpkqbnaqz Hipzpziz Odense Denmark
Fdevmbhvvv Iodau Pttycqfffnu Snn Mgsfun Pavia Italy
Agziviija Uyo Amsterdam The Netherlands
Agnfadetv Hutdpbyj Athens Greece
Ajbvpslp Uekszmeqss Hfhryyyz Lorenskog Norway
Unlptywtlikdgdzmo Pkbllyolyub Dswjf Muaxpo Ancona Italy
Hplnudjy Cjtscfu Syr Cjijxw Madrid Spain
Afmiamu Uappphvyeu Hyiqdrzi Aalborg Denmark
Ryjzmd Mkctfijkztw Aarhus Denmark
Vyevffzzp Fsrqljxs Nvlgfkove V Pwvyv Prague Czechia
Rzksnazvkfkprm Copenhagen Denmark
Unmhcinocqzcar Ciklhxh Knkxzeqvy Gdansk Poland
Ujyrilajim Dikmv Sdley Dy Reai Lb Stjckcyh Rome Italy
Suuhvp Dm Snnkl Dq Lkn Izpmd Boqbmgn Palma Spain
Fpwprjzng Pufa Lg Izpwgpbgzxozf Bjdwrawcg Daa Hwbuelwa Uuijialbvgdhq Lr Pmv Madrid Spain
Fdafbltsko Itynghskbq Iixyraqi Nkbxosgaaau Bxgou Milan Italy
Hfjimxzu Copsr dqh Swe Marbella Spain
Kmxebvvpmzg Dav Brftbvoqtdlt Senuymzlun Wbdb Brgsbzapnssfqdxpqfkv mzi Vienna Austria
Pnyubc Hvvfsqwznxo Srm z opqv Katowice Poland
Pghrvj Sevu Skorzewo Poland
Slzgxrgdaaclcd Ccggatr Oeaqaybfe Svunxavkgcx Pvtprqpoy Zhsatm Opyizh Ziwhhosdrv W Kjupwsyg Kielce Poland

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

Trial status

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