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Study Comparing Teclistamab with Daratumumab, Pomalidomide, and Dexamethasone for Patients with Relapsed or Refractory 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 condition known as Relapsed or Refractory Multiple Myeloma, which is a type of blood cancer that affects plasma cells in the bone marrow. The study aims to compare the effectiveness of different treatment combinations for this condition. One group of participants will receive a combination of Teclistamab and Daratumumab (referred to as Tec-Dara), while another group will receive a combination of Daratumumab, Pomalidomide, and Dexamethasone (referred to as DPd). A third group will receive Daratumumab, Bortezomib, and Dexamethasone (referred to as DVd). Daratumumab and Teclistamab are given as injections under the skin, while Pomalidomide, Dexamethasone, and Bortezomib are taken orally in capsule or tablet form.

The purpose of the study is to compare the effectiveness of these treatment combinations in managing the disease. Participants will be randomly assigned to one of the treatment groups and will receive their respective treatments over a specified period. The study will monitor the participants' health and response to the treatments to gather data on how well each combination works. This will help in understanding which treatment option might be more beneficial for patients with this type of multiple myeloma.

Throughout the study, participants will undergo regular health check-ups and assessments to ensure their safety and to track the progress of their condition. The study is designed to provide valuable insights into the treatment of Relapsed or Refractory Multiple Myeloma and aims to improve the options available for managing this challenging condition.

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

    Upon joining the study, the treatment begins with the administration of teclistamab and daratumumab. Both medications are given as a solution for injection under the skin (subcutaneous use).

    The frequency and dosage of these medications will be determined by the study protocol and the healthcare team overseeing the trial.

  2. Step 2

    Combination therapy phase

    Depending on the assigned group, additional medications may be introduced. These include pomalidomide and dexamethasone, which are taken orally in the form of capsules or tablets.

    Alternatively, bortezomib may be administered as a subcutaneous injection, combined with dexamethasone tablets.

  3. Step 3

    Monitoring and assessment

    Throughout the trial, regular monitoring of health status and response to treatment is conducted. This includes blood tests and other assessments to evaluate the effectiveness of the treatment.

    Adjustments to medication dosages or schedules may occur based on these assessments.

  4. Step 4

    End of treatment phase

    The treatment phase continues until the study's end date or until specific criteria for discontinuation are met, such as disease progression or unacceptable side effects.

    Upon completion, a final evaluation is conducted to assess the overall response to the treatment.

Who can join the trial?

8 criteria

  • The patient must have a confirmed diagnosis of multiple myeloma, which is a type of blood cancer, according to specific medical guidelines.
  • The patient must have a measurable level of disease at the start of the study, which can be shown by certain levels of proteins in the blood or urine.
  • The patient must have received 1 to 3 previous treatments for multiple myeloma, including a type of drug called a proteasome inhibitor and another drug called lenalidomide. If the patient has only had one previous treatment, they must not have responded well to lenalidomide.
  • The patient must show signs that their disease is getting worse, as determined by a doctor using specific criteria.
  • The patient must have a performance status score of 0, 1, or 2, which is a way to measure how well they can perform daily activities.
  • The patient must have certain laboratory test results within a specified range to ensure they are healthy enough to participate.
  • The study is open to both male and female patients.
  • The study includes patients who may be considered vulnerable, meaning they might need extra care or protection.

Who cannot join the trial?

6 criteria

  • Patients who have a different type of cancer other than Relapsed/Refractory Multiple Myeloma cannot participate. This means the study is only for those with this specific condition.
  • Patients who are not within the specified age range cannot participate. The study is for adults, so children and very elderly individuals may not be eligible.
  • Patients who are unable to provide informed consent cannot participate. This means they must be able to understand the study and agree to take part.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
  • Patients with certain other health conditions that might interfere with the study cannot participate. This is to ensure accurate results and the safety of the participants.
  • Patients who have participated in another clinical trial recently may not be eligible. This is to avoid any interference with the results of this study.
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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 being tested in combination with other treatments to see if it can help improve outcomes for patients whose cancer has returned or is not responding to previous treatments.

  • Daratumumab SC

    is a medication used to treat multiple myeloma. It works by targeting a specific protein on the surface of cancer cells, helping the immune system to destroy them. In this study, it is being used both alone and in combination with other drugs to evaluate its effectiveness.

  • Pomalidomide

    is a medication that helps the immune system fight cancer and is used to treat multiple myeloma. It is often used when other treatments have not been successful. In this trial, it is combined with other medications to assess its impact on the disease.

  • Dexamethasone

    is a type of steroid that is used to reduce inflammation and suppress the immune system. It is commonly used in combination with other cancer treatments to help manage multiple myeloma and improve patient outcomes.

  • Bortezomib

    is a medication that interferes with the growth of cancer cells and is used to treat multiple myeloma. It is being tested in combination with other drugs in this study to determine its effectiveness in treating patients with relapsed or refractory multiple myeloma.

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 relapsed or refractory multiple myeloma. The medication works by targeting specific proteins on the surface of cancer cells, helping the immune system to recognize and destroy these cells. It is classified as a monoclonal antibody, which is a type of targeted therapy designed to interfere with cancer cell growth.

  • Daratumumab

    Daratumumab is given as a subcutaneous injection. It is an established treatment for multiple myeloma, particularly in cases where the disease has returned or is resistant to other treatments. The drug functions by binding to a protein on the surface of myeloma cells, marking them for destruction by the immune system. It belongs to the class of monoclonal antibodies, which are used to specifically target and eliminate cancer cells.

  • Pomalidomide

    Pomalidomide is taken orally in pill form. It is used in the treatment of multiple myeloma, especially when the disease has not responded to other therapies. The medication works by modulating the immune system and directly attacking cancer cells, inhibiting their growth and survival. It is classified as an immunomodulatory agent, which helps enhance the body's immune response against cancer.

  • Bortezomib

    Bortezomib is administered through an injection, either under the skin or into a vein. It is used to treat multiple myeloma, particularly in patients who have relapsed or have not responded to other treatments. The drug acts by inhibiting proteasomes, which are structures within cells that break down proteins, leading to cancer cell death. It is part of the proteasome inhibitor class, which disrupts the normal function of cancer cells, causing them to die.

Investigated diseases

Relapsed/Refractory Multiple Myeloma – This is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. In relapsed multiple myeloma, the disease returns after a period of improvement. In refractory multiple myeloma, the disease does not respond to treatment or stops responding after a while. The progression of this disease involves the accumulation of abnormal plasma cells in the bone marrow, leading to bone damage, anemia, kidney dysfunction, and increased risk of infections. Over time, the disease can cause significant damage to bones and organs due to the overproduction of these abnormal cells. Symptoms may include bone pain, fatigue, frequent infections, and high calcium levels in the blood.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503441-55-00Protocol code64007957MMY3001Estimated enrolment529 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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