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

Verified siteRegistered drugNo placebo
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What is this trial about?

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

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

15 criteria

  • 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
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Investigated drugs

  • 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.

What is already known about the treatment

Immune Globulin Infusion (IGIV, 10%) – An intravenously administered immunoglobulin preparation used for immune replacement therapy in patients with compromised immune systems. This medication contains purified antibodies derived from human plasma and is specifically indicated for primary infection prophylaxis in multiple myeloma patients receiving BCMA-directed bispecific antibody therapy. The medication works by providing immediate passive immunity, helping to prevent infections in immunocompromised patients by supplementing their antibody levels. As a blood product-derived medication, it belongs to the pharmacological class of immune globulins and is administered through controlled intravenous infusion under medical supervision.

Investigated diseases

  • 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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518420-80-00Protocol codeTAK-339-3001Estimated enrolment212 patientsSponsorTakeda Development Center Americas Inc.

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