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Study Comparing Talquetamab, Pomalidomide, and Teclistamab for Patients with Relapsed or Refractory Myeloma After 1 to 4 Prior Treatments

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 Relapsed or Refractory Multiple Myeloma, a type of blood cancer that has returned or is not responding to previous treatments. The study will explore different combinations of medications to find the most effective treatment. The medications being tested include Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Bortezomib, and Dexamethasone. Some of these medications are given as tablets or capsules, while others are administered through injections.

The purpose of the study is to compare the effectiveness of these medication combinations. Participants will be randomly assigned to receive one of the following treatments: Talquetamab with Pomalidomide, Talquetamab with Teclistamab, or a combination chosen by the investigator, which could be Elotuzumab, Pomalidomide, and Dexamethasone, or Pomalidomide, Bortezomib, and Dexamethasone. Some participants may receive a placebo. The study will last for a period of up to 24 months, during which participants will receive regular treatments and check-ups to monitor their health and the progress of the disease.

Throughout the study, the main focus will be on measuring how long participants live without the disease getting worse, known as progression-free survival. This will help researchers understand which treatment combination works best for patients with relapsed or refractory multiple myeloma. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

The research process

The trial runs in 6 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 randomly assigned to one of the treatment groups. The study involves comparing different combinations of medications for treating relapsed or refractory myeloma.

  2. Step 2

    Treatment group assignment

    The patient may be assigned to one of the following treatment groups: Talquetamab with Pomalidomide (Tal-P), Talquetamab with Teclistamab (Tal-Tec), or the investigator's choice of either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd).

  3. Step 3

    Medication administration

    The medications will be administered in various forms: oral tablets or capsules, subcutaneous injections, or intravenous infusions. The specific medications and their administration routes are as follows:

    Dexamethasone: Oral tablets.

    Pomalidomide: Oral capsules.

    Talquetamab: Subcutaneous injection.

    Teclistamab: Subcutaneous injection.

    Bortezomib: Subcutaneous injection.

    Elotuzumab: Intravenous infusion.

  4. Step 4

    Treatment duration

    The treatment will continue as per the study protocol, with regular monitoring and assessments to evaluate the patient's response to the treatment. The study aims to compare the effectiveness of the different treatment combinations.

  5. Step 5

    Monitoring and assessments

    Throughout the study, the patient's health and response to the treatment will be closely monitored. This includes regular check-ups, laboratory tests, and assessments to track the progression of the disease and any side effects of the medications.

  6. Step 6

    Study completion

    The study is expected to conclude by June 2027. Upon completion, the results will be analyzed to determine the most effective treatment combination for relapsed or refractory myeloma.

Who can join the trial?

6 criteria

  • Be at least 18 years old or the legal age of consent in the area where the study is happening.
  • Have a confirmed diagnosis of multiple myeloma, which is a type of blood cancer, as defined by specific medical criteria.
  • Have a measurable disease at the time of screening, which means the disease can be detected and measured by tests. This can be shown by certain levels of proteins in the blood or urine.
  • Have a relapsed or refractory disease. Relapsed means the disease returned after responding to treatment. Refractory means the disease did not respond well to treatment.
  • Show evidence of the disease getting worse or not responding to the last treatment, as determined by the study doctor.
  • Have an ECOG performance status score of 0, 1, or 2. This score is used to assess how well a person can perform daily activities. A score of 0 means fully active, 1 means some symptoms but nearly fully active, and 2 means unable to work but able to do most self-care activities.
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Investigated drugs

  • Talquetamab

    This medication is being tested in combination with other treatments to see how well it works for patients with relapsed or refractory myeloma. It is a new type of therapy that targets specific proteins on cancer cells to help the immune system attack them.

  • Pomalidomide

    This is a medication used to treat multiple myeloma. It works by helping the immune system fight cancer and by stopping the growth of cancer cells.

  • Teclistamab

    This is an investigational drug being studied for its potential to treat multiple myeloma. It is designed to help the immune system recognize and destroy cancer cells.

  • Elotuzumab

    This medication is used in combination with other drugs to treat multiple myeloma. It works by targeting a specific protein on the surface of cancer cells, helping the immune system to attack them.

  • Bortezomib

    This is a medication used to treat multiple myeloma. It works by interfering with the growth of cancer cells, eventually leading to their death.

  • Dexamethasone

    This is a steroid medication used to reduce inflammation and suppress the immune system. In cancer treatment, it is often used to help reduce side effects and improve the effectiveness of other cancer therapies.

What is already known about the treatment

  • Talquetamab

    This medication is administered through injection and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory myeloma. It is not yet widely available in medical practice, as it is still under investigation. 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.

  • Pomalidomide

    This medication is taken orally in capsule form and is approved for use in treating multiple myeloma, particularly in patients who have not responded to other treatments. It is well-documented in medical literature and is used in combination with other drugs. Pomalidomide works by modulating the immune system and inhibiting the growth of cancer cells. It belongs to a class of drugs known as immunomodulatory agents.

  • Teclistamab

    Administered via injection, this medication is currently being evaluated in clinical trials for its potential to treat relapsed or refractory myeloma. It is not yet approved for general medical use. Teclistamab functions by binding to specific proteins on cancer cells, facilitating the immune system's ability to target and eliminate these cells. It is classified as a bispecific antibody, which is designed to engage two different targets simultaneously.

  • Elotuzumab

    This medication is given through intravenous infusion and is approved for use in combination with other drugs to treat multiple myeloma. It is well-established in medical literature and is used for patients who have received prior treatments. Elotuzumab works by activating the immune system to attack myeloma cells. It is classified as a monoclonal antibody, which specifically targets proteins on the surface of cancer cells.

  • Bortezomib

    Administered either by injection or intravenously, this medication is approved for the treatment of multiple myeloma and is widely used in clinical practice. It is well-documented in medical literature. Bortezomib works by inhibiting proteasomes, which are enzyme complexes that break down proteins in cells, leading to cancer cell death. It is classified as a proteasome inhibitor, which disrupts the normal function of cancer cells.

Investigated diseases

Relapsed or Refractory Myeloma – This is a type of cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this condition, the myeloma has either returned after treatment (relapsed) or has not responded to treatment (refractory). The disease progresses as abnormal plasma cells multiply, leading to bone damage, kidney problems, and a weakened immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. Over time, the disease can cause significant damage to bones and other organs. The progression of the disease varies, and it can become more challenging to manage as it advances.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502446-27-00Protocol code64407564MMY3009Estimated enrolment932 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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