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Study Comparing Talquetamab, Daratumumab, and Pomalidomide with Drug Combination 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 treatments for Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study involves several medications, including Pomalidomide, Daratumumab, Dexamethasone, and a medication with the code name JNJ-64407564, also known as Talquetamab. These treatments are being tested in different combinations to see how effective they are in treating patients whose multiple myeloma has returned or has not responded to previous treatments.

The purpose of the study is to compare the effectiveness of different combinations of these medications. Participants will receive one of the following treatment combinations: Talquetamab with Daratumumab and Pomalidomide (referred to as Tal-DP), Talquetamab with Daratumumab (referred to as Tal-D), or Daratumumab with Pomalidomide and Dexamethasone (referred to as DPd). The study will monitor participants over a period to assess how well these treatments work in controlling the disease.

Participants in the study will receive their assigned treatment and will be monitored regularly to track their health and the progression of their multiple myeloma. The study aims to find out which combination of treatments is most effective in prolonging the time before the disease worsens, known as progression-free survival. This information will help doctors understand better ways to treat multiple myeloma in the future.

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 verifying a diagnosis of relapsed or refractory multiple myeloma and ensuring previous treatment with at least one line of therapy.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of the treatment groups. The groups include combinations of medications such as talquetamab, daratumumab, pomalidomide, and dexamethasone.

  3. Step 3

    Treatment administration

    The treatment involves the administration of medications through different routes. Talquetamab and daratumumab are given as subcutaneous injections. Pomalidomide and dexamethasone are taken orally in the form of capsules or tablets.

    The specific dosage and frequency depend on the assigned treatment group. The treatment continues as per the study protocol.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and any side effects. This includes blood tests and other necessary evaluations.

    Follow-up visits are scheduled to track progress and make any necessary adjustments to the treatment plan.

  5. Step 5

    Completion of study

    The study is estimated to conclude by May 28, 2029. Upon completion, final assessments are conducted to evaluate the overall outcomes and progression-free survival.

Who can join the trial?

8 criteria

  • The patient must have a confirmed diagnosis of **multiple myeloma**, which is a type of blood cancer. This includes having a measurable level of a specific protein in the blood or urine, or an abnormal level of certain proteins in the blood.
  • The patient must have **relapsed** or **refractory** disease. Relapsed means the disease returned after responding to treatment. Refractory means the disease did not respond well to treatment.
  • The patient must have received at least one previous treatment for multiple myeloma, which included a **proteasome inhibitor** (a type of drug that blocks the action of proteasomes, which are part of the cell's machinery) and **lenalidomide** (a medication used to treat multiple myeloma). If only one previous treatment was received, the patient must not have responded well to lenalidomide.
  • The patient must show evidence that the disease is getting worse, as determined by a doctor using specific criteria.
  • The patient must have an **ECOG performance status** score of 0, 1, or 2. This score is a way to measure how well a patient can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • The patient must be an adult, as the study includes age categories 3 and 4, which typically refer to adults.
  • Both **male** and **female** patients can participate in the study.
  • The study may include individuals from vulnerable populations, which means people who might need special protection or consideration.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer other than Relapsed or Refractory Multiple Myeloma cannot participate. Relapsed means the cancer has come back after treatment, and Refractory means the cancer does not respond to treatment.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
  • Patients who are not part of the specific clinical trial group being studied cannot participate. Clinical trial groups are categories of patients that the study is focusing on.
  • Patients who are not male or female cannot participate, as the study includes both male and female subjects.
  • Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may have a higher risk of harm or exploitation in a study.
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Investigated drugs

  • Talquetamab

    This is an investigational medication being studied for its potential to treat multiple myeloma, a type of blood cancer. It is administered under the skin (subcutaneously) and is being tested in combination with other medications to see if it can help control the disease in patients who have already received other treatments.

  • Daratumumab

    This is a medication used to treat multiple myeloma. It works by targeting and attaching to a specific protein on the surface of cancer cells, helping the immune system to destroy them. In this trial, it is given under the skin and is being used in combination with other treatments to evaluate its effectiveness.

  • Pomalidomide

    This medication is used to treat multiple myeloma by helping the immune system attack cancer cells and by stopping the growth of these cells. It is taken orally and is being tested in combination with other drugs to determine its role in treating patients with relapsed or refractory multiple myeloma.

  • Dexamethasone

    This is a type of steroid medication that helps reduce inflammation and is used to treat various conditions, including multiple myeloma. It is often used in combination with other cancer treatments to enhance their effectiveness and manage symptoms.

What is already known about the treatment

  • Talquetamab

    This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory multiple myeloma, a type of blood cancer. Talquetamab 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

    This medication is also given subcutaneously and is used in the treatment of multiple myeloma. It is an established treatment in medical practice and literature, often used in combination with other drugs. Daratumumab works by binding to a protein on the surface of myeloma cells, marking them for destruction by the immune system. It belongs to the pharmacological class of monoclonal antibodies, which are designed to target specific proteins on cancer cells.

  • Pomalidomide

    Administered orally, this medication is used in combination with other drugs to treat multiple myeloma, particularly in patients who have not responded to other treatments. Pomalidomide works by affecting the immune system and directly attacking cancer cells, slowing their growth and spread. It is classified as an immunomodulatory agent, which helps to modify the immune response to fight cancer more effectively.

  • Dexamethasone

    This medication is taken orally and is used in combination with other treatments for multiple myeloma. It is a well-established medication in medical practice, known for its anti-inflammatory and immunosuppressant properties. Dexamethasone works by reducing inflammation and suppressing the immune system, which can help in controlling the symptoms and progression of multiple myeloma. It is classified as a corticosteroid, which is used to manage inflammation and immune responses.

Investigated diseases

Relapsed or 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 condition leads to the accumulation of abnormal plasma cells in the bone marrow, which can crowd out healthy blood cells. This can result in symptoms such as bone pain, anemia, kidney problems, and increased risk of infections. The disease typically progresses through cycles of remission and relapse, with each relapse potentially being more challenging to treat.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503467-41-00Protocol code64407564MMY3002Estimated enrolment863 patientsSponsorJanssen - Cilag International

sourced from the EU Clinical Trials Register and site verification

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