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Study on the Effectiveness of Talquetamab and Teclistamab in First-Line Treatment for Transplant-Eligible Multiple Myeloma Patients

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 is focused on studying the treatment of Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study will use a combination of medications, including teclistamab (also known by the code name JNJ-64007957), talquetamab (code name JNJ-64407564), lenalidomide, dexamethasone, bortezomib, and darzalex (which contains the active substance daratumumab). These medications are designed to help the immune system target and destroy cancer cells.

The purpose of the study is to determine if adding T-cell redirectors, which are a type of treatment that helps the immune system recognize and attack cancer cells, to the first line of treatment will improve the depth of response in patients. This means the study aims to see if this approach can increase the number of patients who achieve a state where no cancer cells can be detected, known as minimal residual disease (MRD) negativity, and a complete response, where all signs of cancer are gone.

Participants in the study will receive these treatments over a period of time, with the goal of improving their response to the therapy. The study will involve several cycles of treatment with the medications mentioned, and the progress will be monitored to see how well the cancer responds. The study will also include a comparison with a placebo to evaluate the effectiveness of the treatment. The overall aim is to find a more effective treatment strategy for patients with Multiple Myeloma.

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

    The initial treatment phase involves the administration of several medications to manage multiple myeloma. This phase includes the use of daratumumab, bortezomib, lenalidomide, and dexamethasone. These medications are administered through subcutaneous injections and oral routes.

    The goal of this phase is to reduce the disease burden and prepare for the next stages of treatment.

  2. Step 2

    Consolidation therapy with talquetamab

    Following the initial treatment, consolidation therapy with talquetamab is administered. This involves subcutaneous injections over a period of 6 cycles.

    The purpose of this therapy is to further decrease the presence of cancer cells and achieve a deeper response.

  3. Step 3

    Consolidation therapy with teclistamab

    After completing talquetamab therapy, consolidation therapy with teclistamab is initiated. This also involves subcutaneous injections over 6 cycles.

    This step aims to enhance the treatment response and increase the likelihood of achieving minimal residual disease (MRD) negativity.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, regular monitoring is conducted to assess the response to treatment. This includes measuring MRD using advanced techniques and evaluating overall health.

    Follow-up assessments are scheduled to track the long-term effects of the treatment and ensure the maintenance of the achieved response.

Who can join the trial?

18 criteria

  • Participants must be between 18 and 70 years old.
  • Total bilirubin levels must be less than 1.5 times the upper limit of normal. If you have Gilbert's syndrome, a condition that affects bilirubin levels, you may still qualify if your direct bilirubin is less than 1.5 times the upper limit.
  • HIV-positive participants can join if they have no detectable viral load, a CD4+ count greater than 300 cells/mm³, no serious infections related to AIDS in the past 6 months, and are on stable HIV treatment. Changes in treatment due to resistance should be made at least 3 months before joining, and changes due to side effects are allowed up to 4 weeks before joining.
  • Women who can have children must have a negative pregnancy test before starting the study and agree to regular pregnancy tests during the study and for 100 days after the last treatment.
  • Women must either not be able to have children or agree to use effective birth control methods, such as abstinence, a partner with a vasectomy, or two effective contraception methods, with at least one being highly effective.
  • Women must agree not to donate eggs or freeze them for future use during the study and for 6 months after the last treatment.
  • Men must use condoms during any activity that could result in pregnancy during the study and for at least 100 days after the last treatment. If their partner can have children, she must also use a highly effective birth control method.
  • Men must agree not to donate sperm during the study and for at least 100 days after the last treatment.
  • Participants must sign a consent form indicating they understand the study's purpose and procedures and are willing to participate.
  • Participants must be willing and able to follow the lifestyle restrictions specified in the study protocol.
  • Participants must have documented multiple myeloma, a type of blood cancer, meeting specific criteria.
  • Participants must be newly diagnosed and eligible for high-dose therapy and a procedure called autologous stem cell transplant (ASCT).
  • Participants must have an ECOG performance status score of 2 or less, which measures their ability to perform daily activities.
  • Hemoglobin levels must be at least 8 g/dL, and red blood cell transfusions are allowed.
  • Platelet levels must be at least 75 x 10⁹/L if less than 50% of bone marrow cells are plasma cells, or at least 50 x 10⁹/L if 50% or more are plasma cells, without recent transfusion support.
  • Absolute neutrophil count (ANC) must be at least 1.0 x 10⁹/L, with prior growth factor support allowed but not within 7 days for certain growth factors.
  • AST and ALT liver enzyme levels must be less than 2.5 times the upper limit of normal.
  • Estimated creatinine clearance rate (eCFR) must be at least 30 mL/min, which measures kidney function.

Who cannot join the trial?

3 criteria

  • Patients who have a different condition than Multiple Myeloma cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
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Investigated drugs

  • Talquetamab

    is a medication used in this clinical trial as part of the first line treatment for multiple myeloma. It is a bispecific T-cell redirector, which means it helps the immune system target and destroy cancer cells more effectively. The goal is to improve the depth of response in patients, aiming for a higher rate of minimal residual disease negativity and complete response.

  • Teclistamab

    is another bispecific T-cell redirector used in the trial alongside Talquetamab. Like Talquetamab, it works by directing the body's immune cells to attack multiple myeloma cells. The combination of these two medications is being studied to see if it can enhance the treatment outcomes for patients by increasing the likelihood of achieving minimal residual disease negativity and complete response.

What is already known about the treatment

  • Talquetamab

    Talquetamab is administered as an injection, typically under the skin. It is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, a type of blood cancer. The medication works by redirecting T-cells, a type of immune cell, to target and destroy cancer cells. It belongs to a class of drugs known as bispecific T-cell redirectors, which are designed to enhance the body's immune response against cancer.

  • Teclistamab

    Teclistamab is given through an injection, usually subcutaneously. It is under investigation in clinical trials for its potential to treat multiple myeloma. This medication functions by guiding T-cells to attack and eliminate cancerous cells, thereby boosting the immune system's ability to fight the disease. It is classified as a bispecific T-cell redirector, aiming to improve treatment outcomes by increasing the depth of response in cancer therapy.

Investigated diseases

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this disease, abnormal plasma cells multiply uncontrollably, leading to the production of a large amount of abnormal proteins. These proteins can cause damage to bones and organs, particularly the kidneys. As the disease progresses, it can lead to bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also interfere with the production of normal blood cells, leading to various complications. Over time, the disease can cause significant health issues, impacting the quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508212-38-00Protocol codeTALTEC JNJ-54767414Estimated enrolment50 patientsSponsorNorth Estonia Medical Centre Foundation

sourced from the EU Clinical Trials Register and site verification

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