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Study of Elranatamab, Dexamethasone, and Diphenhydramine Hydrochloride for Patients with High-Risk Smoldering 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 a condition known as high-risk smoldering multiple myeloma, which is a type of blood disorder that can potentially develop into a more serious form of cancer called multiple myeloma. The study is investigating the effects of a treatment called Elranatamab, which is a solution for injection developed by Pfizer Inc. The main goal of the study is to determine how effective Elranatamab is in treating patients who have not previously received treatment for this condition.

Participants in the study will receive Elranatamab through subcutaneous injections, which means the medication is administered under the skin. In addition to Elranatamab, some patients may also receive other medications such as Dexamethasone, an oral solution that helps reduce inflammation, Diphenhydramine Hydrochloride, an antihistamine tablet used to relieve allergy symptoms, Paracetamol, a tablet for pain relief and fever reduction, and Tocilizumab, an immunosuppressant given as an intravenous infusion to help control the immune system's activity.

The study will be conducted over a period of time, with regular monitoring to assess the treatment's effects and any side effects. The primary focus is to see if patients achieve complete remission, which means the disease is no longer detectable, by the end of the sixth cycle of treatment. The study will also monitor for any significant side effects that may occur. This research aims to provide valuable information on the potential benefits of Elranatamab for patients with high-risk smoldering multiple myeloma.

The research process

The trial runs in 7 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 informed about the trial's purpose and procedures. An informed consent form must be signed to confirm understanding and willingness to participate.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes a review of medical history and laboratory tests to ensure all criteria are met.

  3. Step 3

    Treatment initiation

    The treatment begins with the administration of elranatamab through subcutaneous injection. The dosage and frequency will be determined by the study protocol.

  4. Step 4

    Supportive medications

    To manage potential side effects, additional medications may be administered. These include dexamethasone and diphenhydramine hydrochloride taken orally, and tocilizumab given intravenously if needed. Paracetamol may also be used orally for pain relief.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring will occur throughout the study to assess the patient's response to treatment and any side effects. This includes physical examinations, blood tests, and other necessary evaluations.

  6. Step 6

    Completion of cycle 6

    At the end of cycle 6, the patient's response will be evaluated based on the International Myeloma Working Group criteria. The primary goal is to assess the complete remission rate.

  7. Step 7

    End of study participation

    Upon completion of the study, the patient will undergo a final assessment. This includes a review of overall health and any long-term effects of the treatment.

Who can join the trial?

13 criteria

  • Must be **18 years of age** or older.
  • Must have been diagnosed with **smoldering multiple myeloma (SMM)** for **5 years or less** with measurable disease. This means having certain levels of proteins in the blood or urine.
  • Must have **bone marrow plasma cells (BMPCs)** between **10% and less than 60%**. BMPCs are a type of cell found in the bone marrow.
  • Must have at least **2 high-risk factors**, such as:
    • Serum M protein of **2 g/dL or more**.
    • BMPCs greater than **20%**.
    • A specific protein ratio in the blood greater than **20**.
    • Must have an **ECOG performance status score** of **0 or 1**. This score measures how well a person can perform daily activities.
    • Must meet certain **laboratory test results** within specific ranges, such as:
      • **Absolute neutrophil count** of **1.0 x 10^9/L** or more. Neutrophils are a type of white blood cell.
      • **Platelet count** of **75 x 10^9/L** or more. Platelets help with blood clotting.
      • **Aspartate aminotransferase (AST)** and **alanine aminotransferase (ALT)** levels no more than **2.5 times** the upper limit of normal. These are liver enzymes.
      • **Total bilirubin** no more than **1.5 times** the upper limit of normal, except for certain conditions like Gilbert syndrome.
      • Must sign an **informed consent form** to show understanding and willingness to participate in the study.
      • Women who can have children must have a **negative pregnancy test** before starting the study and agree to use **two methods of birth control** or abstain from heterosexual intercourse during the study and for at least **5 months** after the last dose of the study drug.
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Investigated drugs

Elranatamab is a medication being studied for its effectiveness in treating patients with high-risk smoldering multiple myeloma, a type of blood cancer. This trial aims to see how well Elranatamab works in patients who have not received any previous treatment for this condition.

What is already known about the treatment

Elranatamab – Elranatamab is administered as an injection, typically given under the skin. It is currently being studied in clinical trials, particularly for its effectiveness in treating high-risk smoldering multiple myeloma, a condition that can progress to a more severe form of cancer. The medication works by targeting specific proteins on the surface of cancer cells, helping the immune system to recognize and destroy these cells. Elranatamab is classified as a monoclonal antibody, a type of drug designed to interact with specific targets in the body to treat diseases.

Investigated diseases

Smoldering Multiple Myeloma – Smoldering multiple myeloma is a condition characterized by an abnormal increase in plasma cells in the bone marrow. These cells produce a protein that can be detected in the blood or urine. Unlike active multiple myeloma, smoldering multiple myeloma does not cause symptoms or organ damage. It is considered a precursor to multiple myeloma, with a risk of progression to the active form of the disease. The condition is monitored closely to detect any signs of progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505775-70-00Protocol codeEMN34Estimated enrolment105 patientsSponsorEmn Trial Office S.r.l. Impresa Sociale

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