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Study of Teclistamab and Lenalidomide as Maintenance Treatment for Newly Diagnosed Multiple Myeloma Patients After Stem Cell Transplantation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Newly Diagnosed Multiple Myeloma who have undergone Autologous Stem Cell Transplantation. The research examines three different treatment approaches as maintenance therapy: teclistamab combined with lenalidomide, teclistamab alone, and lenalidomide alone. Multiple myeloma is a type of blood cancer that affects plasma cells, which are responsible for producing antibodies to fight infections.

The study aims to compare how well these treatments work in preventing the cancer from returning after stem cell transplantation. Teclistamab is given as an injection under the skin, while lenalidomide is taken as capsules by mouth. The treatment continues for up to 24 months, depending on how well patients respond and any side effects they may experience.

During the study, patients will receive regular medical check-ups to monitor their health status and response to treatment. The effectiveness of the treatments will be measured by how long patients remain free of disease progression and whether they achieve a complete response to therapy. Patients will also be monitored for any side effects that may occur during treatment.

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

    Your eligibility for the study will be evaluated if you have been diagnosed with newly diagnosed multiple myeloma and have completed initial treatment with stem cell transplantation

    Laboratory tests and pregnancy tests (if applicable) will be performed to confirm your eligibility

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of three treatment groups:

    Group 1: Teclistamab combined with lenalidomide

    Group 2: Teclistamab alone

    Group 3: Lenalidomide alone

  3. Step 3

    Treatment administration

    Lenalidomide is taken as hard capsules by mouth in doses of 2.5 mg, 5 mg, 10 mg, or 15 mg

    Teclistamab is given as an injection under the skin

    Treatment will continue as maintenance therapy following your stem cell transplantation

  4. Step 4

    Monitoring period

    Regular assessments will be performed to evaluate your response to treatment

    Blood tests will be conducted to monitor your condition

    Your overall health status and any side effects will be tracked throughout the study

  5. Step 5

    Follow-up period

    After completing treatment, you will continue to be monitored for any long-term effects

    The study is expected to continue until November 2031

    Additional follow-up visits will be scheduled to assess your health status

Who can join the trial?

15 criteria

  • Must be 18 years of age or older and legally able to provide consent
  • Must have newly diagnosed Multiple Myeloma and received 4-6 cycles of initial therapy
  • Must have undergone stem cell transplant within the past 12 months from starting initial therapy
  • Must be within 6 months of last transplant (7 months if received additional therapy)
  • Must have achieved at least a partial response to previous treatment
  • Must not have received any maintenance therapy
  • Must have an ECOG performance status of 0-2 (measure of patient's ability to perform daily activities)
  • Must meet required laboratory test values
  • Must be willing to follow the study's lifestyle restrictions
  • For women who can become pregnant:
    • Must have negative pregnancy tests
    • Must use two reliable methods of birth control
    • Must not donate eggs during the study and for specified time after
    • For men:
      • Must use condoms during intimate activity
      • Must not donate sperm during the study and for specified time after
      • Must sign an informed consent form showing understanding of the study

Who cannot join the trial?

15 criteria

  • Active multiple myeloma that has not responded to initial treatment
  • History of significant heart problems including:
    • Heart attack in the past 6 months
    • Unstable heart rhythm disorders
    • Severe heart failure
    • Severe kidney problems requiring dialysis
    • Active or chronic hepatitis B or C infection
    • Known active HIV infection
    • History of other cancers within the past 3 years (except for successfully treated skin cancers or early-stage cancers)
    • Pregnant or breastfeeding women
    • Participation in another clinical trial within the past 30 days
    • Known allergic reactions to similar medications
    • Serious psychiatric conditions that could interfere with the study
    • Unable to take blood-thinning medications
    • Major surgery within 2 weeks before starting the study
    • Any condition that, in the opinion of the study doctor, would make participation unsafe
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Investigated drugs

Teclistamab is a medication that targets specific proteins on cancer cells to help fight multiple myeloma. It works by helping the body's immune system recognize and attack cancer cells more effectively. Lenalidomide is a medication commonly used in multiple myeloma treatment. It works by helping to strengthen the immune system's response against cancer cells and may also help prevent the growth of new blood vessels that feed tumors. The trial also includes combinations of these medications: - Teclistamab combined with Lenalidomide is being studied to see if using both medications together provides better results than using either medication alone - Teclistamab alone is being compared to Lenalidomide alone to determine which single medication might work better as maintenance therapy after stem cell transplantation These medications are being studied specifically as maintenance therapy, which means they are given after stem cell transplantation to help keep the cancer from returning.

What is already known about the treatment

  • Teclistamab

    A bispecific antibody administered through subcutaneous injection that is being investigated for multiple myeloma treatment. This medication works by simultaneously binding to both B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T-cells, helping the immune system target and destroy cancer cells. Currently in clinical trials as maintenance therapy for newly diagnosed multiple myeloma patients following stem cell transplantation, it belongs to the class of immunotherapy agents.

  • Lenalidomide

    An oral immunomodulatory drug that is widely used in the treatment of multiple myeloma. It works by enhancing the immune system's ability to fight cancer cells while also directly inhibiting the growth of myeloma cells and the formation of new blood vessels that support tumor growth. This medication is approved as maintenance therapy after stem cell transplantation and belongs to the class of immunomodulatory drugs (IMiDs).

Investigated diseases

Multiple Myeloma - A type of blood cancer that develops in plasma cells, which are white blood cells that help fight infections. In this condition, abnormal plasma cells multiply uncontrollably in the bone marrow, forming tumors in multiple bones throughout the body. These cancerous cells produce large amounts of abnormal proteins while preventing the production of normal, healthy blood cells. The disease typically affects bones, leading to their weakening, and can impact the body's ability to produce normal blood cells. Multiple myeloma often develops gradually, starting from a precancerous condition called monoclonal gammopathy of undetermined significance (MGUS).
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510384-36-00Protocol codeEMN30Estimated enrolment1 649 patientsSponsorEmn Trial Office S.r.l. Impresa Sociale

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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).