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Study of daratumumab, teclistamab and talquetamab combination treatment for frail patients with newly diagnosed multiple myeloma

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 clinical trial focuses on patients with Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study investigates a combination treatment approach using three medications: daratumumab, teclistamab, and talquetamab. These medications are given as solutions for injection under the skin (subcutaneous injection).

The main purpose of this research is to evaluate how well patients respond to treatment over an 18-month period. The study specifically targets newly diagnosed patients who have not received any previous treatment and are considered frail according to medical assessment criteria. Patients will be divided into two groups - one receiving daratumumab with teclistamab, and the other receiving daratumumab with talquetamab.

During the study, patients will receive their assigned combination of medications through injections under the skin. The treatment will continue while monitoring how well the cancer responds and checking for any side effects. The medications work by helping the body's immune system fight against the cancer cells. Regular medical check-ups and tests will be performed to track the progress of the treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive a combination of medications through subcutaneous injections (injections under the skin).

    Depending on your assigned group, you will receive either Teclistamab with Daratumumab (Group 1) or Talquetamab with Daratumumab (Group 2).

    Regular blood tests will be performed to monitor your condition and measure the response to treatment.

    Your doctor will monitor for any side effects during the treatment period.

  2. Step 2

    Disease monitoring

    Your condition will be regularly assessed to check how well the treatment is working.

    The main assessment will occur at 18 months after starting treatment.

    Tests will include measuring the levels of M-protein (a protein produced by myeloma cells) in your blood.

    Additional tests will be performed to check for signs of minimal residual disease (MRD), which means looking for any remaining cancer cells.

  3. Step 3

    Follow-up period

    After completing the initial treatment, you will continue to be monitored for any changes in your condition.

    Regular assessments will track how long the treatment effects last.

    If needed, additional treatment may be considered based on your response to the initial therapy.

    The total study duration is planned until February 2034.

  4. Step 4

    Safety monitoring

    Throughout the study, you will be monitored for any side effects or complications.

    Special attention will be paid to tracking any infections that may occur.

    Blood tests will be regularly performed to check your overall health status.

    Any treatment-related issues will be documented and addressed by your healthcare team.

Who can join the trial?

8 criteria

  • Must be 18 years or older
  • Must be able to understand and sign an informed consent form showing willingness to participate in the study
  • Must be newly diagnosed with Multiple Myeloma and have not received any previous treatment
  • Must have measurable disease, which means either:
    • A specific protein (M-protein) level in blood of 1 g/dL or higher, or
    • A specific type of protein (free light chain) level of 10 mg/dL or higher with abnormal protein ratios in blood
    • Must be classified as frail according to specific medical criteria
    • Must meet specific laboratory test requirements
    • If able to have children, must agree to use effective birth control methods during the study and for 3 months after the last dose of study medication

Who cannot join the trial?

15 criteria

  • Prior treatment for multiple myeloma (a type of blood cancer affecting plasma cells)
  • History of cancer within the past 5 years, except for successfully treated non-melanoma skin cancer
  • Known allergies or severe reactions to the study medications or their components
  • Serious heart conditions, including:
    • Heart failure requiring treatment
    • Uncontrolled high blood pressure
    • Unstable heart rhythm problems
    • Active or chronic infections, including:
      • Hepatitis B (liver infection)
      • Hepatitis C (liver infection)
      • HIV (human immunodeficiency virus)
      • Severe kidney problems requiring dialysis
      • Severe liver problems
      • Pregnancy or breastfeeding
      • Participation in other clinical trials within the past 30 days
      • Mental conditions that could interfere with following study procedures
      • Any condition that, in the opinion of the study doctor, would make participation unsafe
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Investigated drugs

  • Teclistamab

    is a medication used to treat multiple myeloma, a type of blood cancer. It works by helping your immune system recognize and fight cancer cells. This medication is designed to target specific proteins found on cancer cells, making it a targeted therapy.

  • Talquetamab

    is also a treatment for multiple myeloma. Like teclistamab, it works by engaging your immune system to fight cancer cells. It targets different proteins on the surface of cancer cells to help destroy them.

  • Daratumumab

    (often called Dara) is an antibody therapy used in treating multiple myeloma. It works by targeting a specific protein found on myeloma cells, helping the immune system identify and destroy these cancer cells. It's commonly used in combination with other treatments to improve their effectiveness.

What is already known about the treatment

  • Teclistamab

    A novel bispecific antibody administered through subcutaneous injection, designed to target both BCMA on multiple myeloma cells and CD3 on T-cells. This medication is currently being investigated in clinical trials for newly diagnosed multiple myeloma, particularly in frail patients, and has shown promising results in early studies. It works by bringing T-cells close to cancer cells, enabling the immune system to recognize and destroy the myeloma cells more effectively, representing an innovative approach in immunotherapy treatment.

  • Talquetamab

    A first-in-class bispecific antibody administered subcutaneously, targeting both GPRC5D on multiple myeloma cells and CD3 on T-cells. Currently under clinical investigation for newly diagnosed multiple myeloma patients, particularly in frail populations, this medication represents a novel immunotherapy approach. The drug functions by creating a bridge between T-cells and cancer cells, facilitating the immune system's ability to target and eliminate multiple myeloma cells.

  • Daratumumab

    A monoclonal antibody administered intravenously or subcutaneously, targeting CD38 protein found on multiple myeloma cells. This established medication is approved for multiple myeloma treatment and is being studied in combination with newer agents to enhance therapeutic outcomes. It works by directly targeting cancer cells and stimulating the immune system's natural ability to fight cancer, while also demonstrating the ability to enhance the effects of other anti-myeloma treatments.

Investigated diseases

Multiple Myeloma - A blood cancer that develops in plasma cells, which are white blood cells that help fight infection. 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, called M proteins, which can cause various complications. The disease often affects multiple bones in the body, leading to weakened bones and potential fractures. Multiple myeloma typically develops gradually, starting from a precancerous condition called monoclonal gammopathy of undetermined significance (MGUS). The disease can cause various symptoms including bone pain, frequent infections, fatigue, and kidney problems.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520433-76-00Protocol codeEMN37Estimated enrolment150 patientsSponsorEmn Trial Office S.r.l. Impresa Sociale

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