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Study on the Safety and Effectiveness of Teclistamab and Talquetamab for Patients with Newly Diagnosed Multiple Myeloma Eligible for Transplant

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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 blood. The study is specifically for patients who have been newly diagnosed and are eligible for a procedure called stem cell transplantation. The trial will explore the safety and effectiveness of different treatment combinations that include medications such as teclistamab and talquetamab. These medications are given through an injection under the skin, known as a subcutaneous injection. Another medication involved in the study is lenalidomide, which is taken orally in the form of a capsule. Additionally, the study will look at the use of daratumumab, which is also administered as an injection.

The purpose of the study is to evaluate how safe and tolerable these medication combinations are for patients with newly diagnosed Multiple Myeloma. Participants in the study will receive these treatments over a period of time, and the researchers will monitor them to see how their bodies respond. The study will also assess how well these treatments work in controlling the disease and improving the patients' health. The trial will include different groups of participants, each receiving a specific combination of the medications mentioned.

Throughout the study, participants will undergo regular check-ups and tests to ensure their safety and to gather information on the effectiveness of the treatments. The study aims to provide valuable insights into how these medication combinations can be used to treat Multiple Myeloma, potentially leading to better treatment options for patients in the future.

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

    Initial treatment phase

    The initial treatment phase involves the administration of teclistamab and talquetamab through subcutaneous injections. These medications are designed to target specific proteins on the surface of cancer cells.

    During this phase, the patient will receive these injections at regular intervals as determined by the study protocol. The exact frequency and dosage will be specified by the healthcare provider overseeing the trial.

  2. Step 2

    Oral medication phase

    In addition to the injections, the patient will take lenalidomide in the form of hard capsules. This medication is taken orally and is intended to help control the growth of cancer cells.

    The dosage of lenalidomide may vary, with options including 5 mg, 10 mg, 15 mg, and 25 mg capsules. The healthcare provider will determine the appropriate dosage and frequency based on the patient's specific needs and response to treatment.

  3. Step 3

    Combination treatment phase

    The patient will continue to receive a combination of teclistamab, talquetamab, and lenalidomide as part of the treatment regimen. This phase aims to enhance the effectiveness of the treatment by using multiple medications that work together.

    The healthcare provider will monitor the patient's response to the treatment and adjust the medication plan as necessary to optimize outcomes.

  4. Step 4

    Maintenance phase

    Following the initial and combination treatment phases, the patient will enter a maintenance phase. This phase is designed to sustain the benefits achieved during earlier treatment stages.

    During maintenance, the patient may continue to receive teclistamab and talquetamab injections, along with oral lenalidomide, at a frequency determined by the healthcare provider.

  5. Step 5

    Additional treatment with daratumumab

    In some cases, the patient may receive daratumumab, a solution for injection, as part of the treatment plan. This medication is administered subcutaneously and is intended to further target cancer cells.

    The inclusion of daratumumab in the treatment regimen will be based on the patient's specific condition and response to previous treatments.

  6. Step 6

    Monitoring and follow-up

    Throughout the trial, the patient's health and response to treatment will be closely monitored. This includes regular check-ups, blood tests, and other assessments as needed.

    The healthcare provider will evaluate the patient's progress and make any necessary adjustments to the treatment plan to ensure the best possible outcomes.

Who can join the trial?

15 criteria

  • Be between 18 and 70 years old.
  • Sign a form to show understanding of the study and willingness to participate.
  • Have a confirmed diagnosis of multiple myeloma according to specific criteria.
  • Have a measurable disease, which means certain levels of specific proteins in the blood or urine.
  • Be newly diagnosed and have a treatment plan that includes high-dose therapy (HDT) and autologous stem cell transplantation (ASCT).
  • For certain study groups, have received 4 to 6 cycles of specific drug therapy and ASCT, with possible additional treatment cycles.
  • Have received only one line of therapy and achieved at least a partial response, meaning the disease has improved based on specific criteria.
  • Have undergone HDT and ASCT within 12 months of starting therapy and be within 6 months of the last ASCT.
  • Have a performance status score of 0 to 2, indicating the ability to carry out daily activities.
  • Meet specific laboratory test values for blood and chemistry levels.
  • If female and able to have children, have a negative pregnancy test and agree to further tests during the study.
  • If of childbearing potential, use two effective methods of birth control during the study and for 6 months after the last treatment dose.
  • If female, agree not to donate eggs during the study and for 6 months after the last treatment dose.
  • If male, wear a condom during activities that could result in pregnancy and agree not to donate sperm during the study and for 100 days after the last treatment dose.
  • Be willing to follow lifestyle restrictions specified in the study protocol.
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Investigated drugs

  • Teclistamab

    is a medication being studied for its potential to treat multiple myeloma, a type of blood cancer. It works by helping the immune system target and destroy cancer cells. In this trial, researchers are evaluating how safe and effective it is when used in combination with other treatments for patients who are newly diagnosed and eligible for a transplant.

  • Talquetamab

    is another medication under investigation for treating multiple myeloma. It is designed to engage the immune system to attack cancer cells. The trial is assessing its safety and effectiveness when combined with other therapies in patients who have recently been diagnosed with multiple myeloma and are candidates for a transplant.

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 safety and effectiveness in treating newly diagnosed multiple myeloma in patients eligible for stem cell transplantation. 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, a type of drug designed to interact with specific targets in the body.

  • Talquetamab

    Talquetamab is also administered via injection, usually under the skin. It is under investigation in clinical trials to assess its safety and efficacy for patients with newly diagnosed multiple myeloma who are candidates for stem cell transplantation. This medication functions by binding to certain proteins on cancer cells, aiding the immune system in identifying and eliminating these cells. Talquetamab is classified as a monoclonal antibody, which is a category of drugs that specifically target certain molecules in the body.

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 bone damage, anemia, and increased risk of infections. As the disease progresses, it can cause bone pain, fractures, and kidney problems due to the accumulation of abnormal proteins produced by the cancer cells. The disease often develops slowly and may not show symptoms initially, but over time, it can lead to significant health issues. It is typically diagnosed in older adults and is considered a rare disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517382-17-00Protocol codeGMMG-HD10/ DSMM XXEstimated enrolment130 patientsSponsorUniversitaetsklinikum Heidelberg AöR

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).