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Study of Teclistamab with Daratumumab or Lenalidomide for Elderly 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 is focused on studying a disease called Multiple Myeloma, which is a type of cancer that affects the bone marrow. The study is testing a new treatment approach using a combination of medications. The medications being studied are Teclistamab, Daratumumab, and Lenalidomide. Teclistamab is a special type of protein called a bispecific antibody, which is designed to help the immune system target and destroy cancer cells. Daratumumab is another antibody that works by attaching to cancer cells and helping the immune system to eliminate them. Lenalidomide is a medication that helps to slow down or stop the growth of cancer cells.

The purpose of this study is to evaluate how effective the combination of these medications is in treating elderly patients who have been newly diagnosed with Multiple Myeloma. Participants in the study will receive these medications through injections or capsules over a period of time. The study will monitor the participants' responses to the treatment, looking for improvements in their condition. The study will also keep track of any side effects that may occur during the treatment.

Throughout the study, participants will undergo regular check-ups to assess their health and the progress of the treatment. The study aims to determine if the combination of these medications can provide a significant benefit to patients with Multiple Myeloma, potentially leading to better treatment options in the future. The study is expected to continue for several years to gather comprehensive data on the effectiveness and safety of the treatment.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Eligibility criteria include being at least 65 years old and having a documented diagnosis of multiple myeloma.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of teclistamab and either daratumumab or lenalidomide.

    Teclistamab and daratumumab are given as subcutaneous injections, while lenalidomide is taken orally.

  3. Step 3

    Treatment cycles

    The treatment is organized into cycles. Each cycle involves regular administration of the medications as prescribed by the study protocol.

    The primary goal is to achieve a very good partial response or better after four cycles of treatment.

  4. Step 4

    Monitoring and evaluation

    Throughout the study, regular monitoring is conducted to evaluate the response to treatment and any side effects.

    Assessments include measuring the rate of response and monitoring for any adverse events.

  5. Step 5

    Completion of treatment

    The study aims to continue treatment until the desired outcomes are achieved or until the study's end date.

    The estimated end date for the study is December 21, 2030.

Who can join the trial?

15 criteria

  • The patient must be at least 65 years old.
  • The patient must have a confirmed diagnosis of multiple myeloma, which is a type of cancer affecting plasma cells in the bone marrow. This includes having certain levels of plasma cells or specific signs of the disease, such as high calcium levels, kidney problems, anemia, or bone damage.
  • The patient must have an ECOG performance status score of 0, 1, or 2, which is a scale used to assess how well a patient can perform daily activities.
  • The patient should not be considered for high-dose chemotherapy with ASCT (autologous stem cell transplant).
  • The patient must have certain laboratory test results, such as:
    • Hemoglobin levels of at least 8 g/dL without recent blood transfusions.
    • Platelet count of at least 75,000 per microliter if less than 50% of bone marrow cells are plasma cells, or at least 50,000 per microliter if 50% or more are plasma cells.
    • Absolute neutrophil count of at least 1,000 per microliter.
    • AST and ALT levels no more than 2.5 times the upper limit of normal.
    • eGFR (a measure of kidney function) of at least 30 mL/min.
    • Total bilirubin levels no more than 2 times the upper limit of normal, unless the patient has a condition like Gilbert's syndrome.
    • Serum calcium levels within a certain range.
    • A male patient must use a condom during activities that could result in pregnancy during the study and for a specified time after the last dose of study medication. If the female partner can become pregnant, she must also use a highly effective birth control method.
    • A male patient must agree not to donate sperm for a specified time after the last dose of study medication.
    • The patient must sign an informed consent form, indicating they understand the study's purpose and procedures and agree to participate.
    • The patient must be willing and able to follow the study's rules and restrictions as outlined in the informed consent form.

Who cannot join the trial?

15 criteria

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another type of cancer in the past, unless it was treated and has not come back for a certain period.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have received certain treatments for their condition within a specific time before the study starts.
  • Patients who have allergies to the study medications or their ingredients.
  • Patients who have participated in another clinical trial recently.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have certain heart conditions or have had a heart attack recently.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have certain liver or kidney problems.
  • Patients who have a history of certain lung diseases.
  • Patients who have a history of certain blood disorders.
  • Patients who have a history of certain immune system disorders.
  • Patients who are unable to follow the study procedures or instructions.
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Investigated drugs

  • Teclistamab

    is an investigational medication being studied for its potential to treat multiple myeloma, a type of blood cancer. It is designed to help the immune system target and destroy cancer cells more effectively.

  • Daratumumab

    is a medication used to treat multiple myeloma. It works by attaching to a specific protein on the surface of cancer cells, helping the immune system to identify and eliminate these cells.

  • Lenalidomide

    is a medication used in the treatment of multiple myeloma. It helps the immune system fight cancer by enhancing the body's natural defense mechanisms and directly attacking cancer cells.

What is already known about the treatment

  • Teclistamab

    Teclistamab is administered as an injection, typically given 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 these cells. It is classified as a bispecific antibody, which means it can bind to two different types of proteins at the same time.

  • Daratumumab

    Daratumumab is given as an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. It is an approved medication for multiple myeloma and is being further studied in combination with other drugs. Daratumumab works by attaching to a protein on the surface of cancer cells, marking them for destruction by the immune system. It belongs to a class of drugs known as monoclonal antibodies.

  • Lenalidomide

    Lenalidomide is taken orally in the form of a capsule. It is an established treatment for multiple myeloma and is being evaluated in combination therapies. The drug functions by modulating the immune system and inhibiting the growth of cancer cells. Lenalidomide is classified as an immunomodulatory agent, which means it helps regulate the immune response to fight cancer.

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 crowd out healthy blood cells, leading to issues such as anemia, bone damage, and kidney problems. As the disease progresses, it can cause bone pain, frequent infections, and fatigue due to the overproduction of abnormal proteins. These proteins can also lead to kidney damage and other complications. The disease often progresses slowly, but it can become more aggressive over time. It is considered a rare disease and requires careful monitoring to manage its symptoms and progression.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IITrial ID2024-514101-65-00Protocol code2022_0174Estimated enrolment74 patientsSponsorCentre Hospitalier Universitaire De Lille

sourced from the EU Clinical Trials Register and site verification

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