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Study Comparing Teclistamab, Talquetamab, and Drug Combination for Patients with Newly Diagnosed Multiple Myeloma Not Suitable for Stem Cell Transplant

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 treatments for Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study will compare different combinations of medications to see which is more effective. The medications being tested include Teclistamab and Talquetamab, both used in combination with Daratumumab and Lenalidomide. Another group will receive a combination of Daratumumab, Lenalidomide, and Dexamethasone. These medications are given as injections or capsules.

The purpose of the study is to compare the effectiveness of these different treatment combinations in people who have been newly diagnosed with Multiple Myeloma and are not eligible for a stem cell transplant as their initial therapy. Participants will be randomly assigned to one of the treatment groups and will receive their assigned treatment over a period of time. The study will monitor the participants' health and response to the treatment to determine which combination works best.

Throughout the study, participants will receive regular check-ups and monitoring to ensure their safety and to track the progress of the treatment. The study aims to provide valuable information on the best treatment options for people with Multiple Myeloma who cannot undergo a stem cell transplant.

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 treatment phase

    Upon joining the study, the patient will begin the initial treatment phase. This phase involves the administration of medications designed to treat multiple myeloma, a type of blood cancer.

    The patient will receive a combination of medications, which may include teclistamab, talquetamab, daratumumab, lenalidomide, and dexamethasone. These medications are administered in different forms such as injections and oral capsules or tablets.

  2. Step 2

    Medication administration

    The patient will receive teclistamab and talquetamab as a solution for injection, administered subcutaneously, which means under the skin.

    The patient will also take lenalidomide in the form of hard capsules, and dexamethasone in tablet form, both taken orally.

  3. Step 3

    Treatment regimen

    The treatment regimen involves a combination of these medications, with specific dosages and frequencies determined by the study protocol. The exact schedule will be provided by the healthcare team overseeing the trial.

    The patient will continue this regimen for the duration specified by the study, which aims to evaluate the effectiveness of the treatment combinations.

  4. Step 4

    Monitoring and assessment

    Throughout the trial, the patient's health and response to the treatment will be closely monitored. This includes regular check-ups and assessments to track progress and any side effects.

    The primary goal is to compare the effectiveness of different treatment combinations in managing multiple myeloma.

  5. Step 5

    Completion of trial

    The trial is expected to continue until June 28, 2033. Upon completion, the patient's overall response to the treatment will be evaluated.

    The results will contribute to understanding the best treatment options for individuals with newly diagnosed multiple myeloma who are not candidates for stem cell transplant.

Who can join the trial?

7 criteria

  • Have a diagnosis of multiple myeloma, which is a type of blood cancer, according to specific medical guidelines.
  • Be newly diagnosed and not suitable for high-dose chemotherapy with autologous stem cell transplant (ASCT) because of:
    • Advanced age making it unsafe.
    • Other health conditions that could make the treatment difficult to handle.
    • Choosing to delay this type of treatment as the first option.
    • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2, which is a way to measure how well you can perform daily activities.
    • Agree not to be pregnant, breastfeeding, or planning to become pregnant while in the study or for 6 months after the last treatment dose.
    • Agree not to plan to father a child while in the study or for 100 days after the last treatment dose.
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Investigated drugs

  • Teclistamab

    is an investigational medication being studied for its potential to treat multiple myeloma. It is used in combination with other medications to see if it can help control the disease more effectively.

  • Daratumumab SC

    is a medication used to treat multiple myeloma. It is given as a subcutaneous injection, which means it is injected under the skin. It works by helping the immune system to attack and destroy cancer cells.

  • Lenalidomide

    is a medication that helps to slow down or stop the growth of cancer cells. It is often used in combination with other treatments for multiple myeloma to improve their effectiveness.

  • Talquetamab

    is another investigational medication being tested for its ability to treat multiple myeloma. It is used in combination with other drugs to determine if it can provide better outcomes for patients.

  • Dexamethasone

    is a type of steroid medication that helps reduce inflammation and suppress the immune system. In the context of multiple myeloma, it is used to help control symptoms and enhance the effects of other cancer treatments.

What is already known about the treatment

  • Teclistamab

    Teclistamab is administered as an injection 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 targeting specific proteins on cancer cells, helping the immune system to recognize and destroy them. It is classified as a monoclonal antibody, which is a type of targeted cancer therapy.

  • Daratumumab

    Daratumumab is given as a subcutaneous injection and is an established treatment for multiple myeloma. It is widely recognized in medical literature for its role in targeting and binding to a specific protein on the surface of myeloma cells, leading to their destruction by the immune system. This medication is classified as a monoclonal antibody.

  • Lenalidomide

    Lenalidomide is taken orally in the form of capsules. It is a well-known medication used in the treatment of multiple myeloma and works by modulating the immune system and inhibiting the growth of cancer cells. It belongs to a class of drugs known as immunomodulatory agents.

  • Talquetamab

    Talquetamab is administered as an injection under the skin and is currently under investigation in clinical trials for multiple myeloma. It functions by engaging the immune system to target and eliminate cancer cells. Talquetamab is classified as a monoclonal antibody, focusing on specific proteins found on myeloma cells.

  • Dexamethasone

    Dexamethasone is taken orally in tablet form and is commonly used in combination with other medications for multiple myeloma. It acts as an anti-inflammatory and immunosuppressant, helping to reduce inflammation and modulate the immune response. It is classified as a corticosteroid.

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, cancerous plasma cells multiply and accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. As the disease progresses, it can cause symptoms such as bone pain, frequent infections, anemia, and kidney problems. The abnormal plasma cells produce a large amount of a single type of antibody, which can be detected in the blood or urine. Over time, the accumulation of these cells and proteins can lead to complications affecting various organs and systems in the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503442-30-00Protocol code64007957MMY3005Estimated enrolment1 514 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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