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Study on Teclistamab and Drug Combination for Newly Diagnosed 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 a disease called Multiple Myeloma, which is a type of cancer that affects plasma cells in the bone marrow. The study will explore a treatment strategy that includes several medications: Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone. These medications are used in combination to treat newly diagnosed patients with Multiple Myeloma. The purpose of the study is to evaluate how well this treatment strategy works in reducing the disease to a minimal level, known as minimal residual disease (MRD), and to see if it can help patients maintain this low level of disease over time.

The study will involve two groups of patients. One group will include patients who have achieved MRD negativity, meaning their disease is at a very low level after initial treatment. The other group will include patients who still have detectable disease. The study will assess how well the treatment helps patients in both groups maintain or achieve MRD negativity. Patients will receive the treatment over a period of time, and their response to the treatment will be monitored regularly. The study will also compare the effects of the treatment with a placebo to understand its effectiveness better.

Throughout the study, patients will receive the medications in different forms, such as tablets or injections, depending on the specific drug. For example, Daratumumab and Bortezomib are given as injections, while Lenalidomide and Dexamethasone are taken orally. The study aims to provide valuable information on how these treatments can help manage Multiple Myeloma and improve patient outcomes. Participants will be closely monitored to ensure their safety and to gather data on the treatment's effectiveness.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be assigned to one of two groups based on their initial response to treatment. This is determined by the presence or absence of minimal residual disease (MRD) after initial therapy.

  2. Step 2

    Initial treatment phase

    The patient will receive a combination of medications including daratumumab, bortezomib, lenalidomide, and dexamethasone. These medications are administered to treat multiple myeloma.

    Daratumumab is given as a subcutaneous injection, bortezomib as a subcutaneous injection, lenalidomide is taken orally, and dexamethasone is administered either orally or intravenously.

  3. Step 3

    MRD assessment

    After the initial treatment phase, the patient's MRD status will be assessed. This determines whether the patient will continue in Cohort A or Cohort B.

  4. Step 4

    Cohort A: maintenance therapy

    Patients in Cohort A, who are MRD negative, will receive maintenance therapy to sustain MRD negativity. This involves continued administration of the initial medications over a series of cycles.

  5. Step 5

    Cohort B: conversion therapy

    Patients in Cohort B, who are MRD positive, will receive additional therapy aimed at converting their status to MRD negative. This may involve adjustments in medication dosage or frequency.

  6. Step 6

    Ongoing monitoring

    Throughout the study, the patient's health and response to treatment will be closely monitored. This includes regular assessments of MRD status and any side effects experienced.

  7. Step 7

    Final assessment

    At the end of the study period, a final assessment will be conducted to evaluate the patient's overall response to the treatment and the sustainability of MRD negativity.

Who can join the trial?

11 criteria

  • Patients must be between 18 and 65 years old.
  • Patients must have a confirmed diagnosis of multiple myeloma, which is a type of blood cancer.
  • Patients should be newly diagnosed and eligible for high-dose therapy and a procedure called autologous stem cell transplant (SCT), which involves using the patient's own stem cells.
  • Patients must have a Karnofsky performance status score of at least 50%, which is a way to measure their ability to perform daily activities.
  • Patients must have certain blood and laboratory test results within specific ranges, such as hemoglobin, platelets, and kidney function.
  • Male patients must agree to use a condom during sexual activity and not donate sperm during the study and for 6 months after the last treatment dose.
  • Female patients of childbearing potential must have a negative pregnancy test before starting the study and agree to use two reliable methods of contraception during the study and for 6 months after the last treatment dose.
  • Female patients must agree not to donate eggs during the study and for 6 months after the last treatment dose.
  • Patients must provide written informed consent, which means they agree to participate in the study after understanding its details.
  • Patients must be willing to follow the lifestyle restrictions required by the study.
  • Patients must be affiliated with the French social security system or be a beneficiary of it.

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of allergic reactions to the study medication.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients with certain infections that could affect the study results.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have had a recent major surgery.
  • Patients with certain heart conditions that could pose a risk during the study.
  • Patients who are taking medications that might interfere with the study treatment.
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Investigated drugs

  • Daratumumab

    is a medication used in the treatment of multiple myeloma. It works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells.

  • Bortezomib

    is a drug that helps treat multiple myeloma by interfering with the growth of cancer cells. It works by blocking a certain protein that cancer cells need to grow and multiply.

  • Lenalidomide

    is a medication that helps treat multiple myeloma by affecting the immune system. It works by slowing the growth of cancer cells and helping the body’s immune system to attack the cancer.

  • Dexamethasone

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

What is already known about the treatment

Daratumumab – This medication is administered intravenously and is currently used in the treatment of multiple myeloma. It is well-documented in medical literature as an effective therapy for this condition. Daratumumab works by targeting a specific protein on the surface of myeloma cells, leading to their destruction by the immune system. It is classified as a monoclonal antibody, which is a type of targeted 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. These cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones, kidneys, and the immune system. As the disease progresses, it can result in bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also lead to a decrease in the production of normal blood cells, causing fatigue and other related symptoms. Over time, the disease can cause significant damage to the bones and other organs, impacting overall health and quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508310-41-00Protocol codeRC23_0267Estimated enrolment103 patientsSponsorCentre Hospitalier Universitaire De Nantes

sourced from the EU Clinical Trials Register and site verification

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