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Study of the effects of stopping elranatamab and teclistamab treatment in patients with multiple myeloma who have had a significant response to therapy.

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What is this trial about?

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

This study is being conducted to evaluate how long people can stay in remission after stopping a specific type of treatment for Multiple Myeloma, which is a type of blood cancer that affects plasma cells in the bone marrow. The study focuses on patients who have had a significant reduction in their M-spike, a measurement of the abnormal protein produced by cancer cells in the blood. The medications being studied are elranatamab and teclistamab, which are known as BCMA-CD3 bispecific antibodies. These are specialized drugs designed to help the immune system find and attack the cancer cells.

The purpose of this study is to determine how long the disease remains inactive and how much time can pass without treatment after the medications are stopped. During the study, patients will receive the medication through a subcutaneous injection, which is a shot given into the fatty tissue just under the skin. Participants will be monitored to see if the cancer returns or if the response to the treatment lasts over time. Researchers will also look at how the medications affect overall survival and the frequency of side effects, such as infections, both during and after the treatment period.

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

    <b>treatment phase</b>

    Administration of elranatamab (elrexfio) or teclistamab (tecvayli) through subcutaneous injections, which are shots delivered into the fatty tissue just under the skin.

    The specific dosage and frequency of these bispecific antibodies, which are medications designed to target specific proteins on cancer cells, will be determined based on the assigned treatment.

  2. Step 2

    <b>monitoring for response</b>

    Evaluation to determine if a major M-spike response is achieved. the M-spike is a measurement of a specific protein produced by multiple myeloma (a type of blood cancer) cells.

  3. Step 3

    <b>treatment discontinuation</b>

    Stopping the bispecific antibody therapy once a major response is confirmed.

  4. Step 4

    <b>follow-up and monitoring</b>

    Observation of the duration of remission, which is the period when the disease shows no signs of activity, following the end of treatment.

    Assessment of disease-free survival at 6 months and 3 years to monitor for any signs of the cancer returning.

    Periodic monitoring of overall survival and progression-free survival, which tracks how long the disease remains stable.

    Evaluation of quality of life and symptom burden through regular questionnaires to track changes in physical and mental well-being.

    Monitoring for any adverse events, such as infections, and tracking any need for hospitalization.

Who can join the trial?

10 criteria

  • You must provide written consent, which means you sign a document agreeing to take part in the study.
  • You must have a diagnosis of multiple myeloma, which is a type of cancer that affects the plasma cells in your blood.
  • You must be currently receiving BCMA-CD3 bispecific antibody therapy, a specific type of immune system treatment.
  • You must have achieved a biochemical complete response, meaning that tests show your cancer is currently undetectable or very low.
  • Your M-spike, which is a measurement of a specific protein produced by the cancer, must be unmeasurable or at a very low level.
  • Your free light chains, which are small proteins produced by plasma cells, must be within a normal range or unmeasurable.
  • You must have had measurable disease before starting this specific treatment, meaning your cancer levels were high enough to be clearly detected by tests.
  • You must have your baseline data from your initial diagnosis, which refers to your original medical test results.
  • You must have records of your earlier treatments for multiple myeloma.
  • You must be 18 years of age or older.

Who cannot join the trial?

4 criteria

  • You are unable to follow the specific rules and schedules for monitoring your disease as required by the study plan.
  • You have a severe concomitant disease, which means a serious other medical condition, that is expected to limit your life expectancy to less than 6 months.
  • You are unable to provide informed consent, which is the formal legal agreement to participate in a study after understanding all the risks and benefits.
  • Your multiple myeloma is of the IgD or IgE type, which are specific and rare versions of this blood cancer defined by the type of proteins found in your blood.
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Investigated drugs

  • Elranatamab

    is a type of immunotherapy given as a subcutaneous injection. It is designed to help the body's immune system recognize and attack certain cancer cells in patients with multiple myeloma.

  • Teclistamab

    is a type of immunotherapy given as a subcutaneous injection. It works by linking the body's own immune cells to the cancer cells to help destroy them in patients with multiple myeloma.

What is already known about the treatment

  • Elranatamab

    This medication is an injectable liquid administered through a shot under the skin to treat patients with multiple myeloma. It is currently an approved treatment used to target specific proteins on cancer cells to help the body's immune system find and destroy them. As a bispecific antibody, it works by acting like a bridge that connects immune cells directly to the cancer cells, triggering an attack.

  • Teclistamab

    This medication is an injectable liquid administered through a shot under the skin to treat patients with multiple myeloma. It is currently an approved treatment used to target specific proteins on cancer cells to help the body's immune system find and destroy them. As a bispecific antibody, it works by acting like a bridge that connects immune cells directly to the cancer cells, triggering an attack.

Investigated diseases

Multiple myeloma - This is a type of cancer that develops in the plasma cells, which are a type of white blood cell. These abnormal cells accumulate in the bone marrow and interfere with the production of healthy blood cells. As the disease progresses, the plasma cells produce large amounts of an abnormal protein. This accumulation can lead to damage in various parts of the body, particularly the bones. The condition often evolves through stages of increasing cell activity within the marrow.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524022-18-00Protocol codeSWE-DISCO-MM1Estimated enrolment200 patientsSponsorVaestra Goetalandsregionen

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