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Study of Daratumumab Injection for Patients with High-Risk Smoldering Multiple Myeloma

Fast replyInvestigationalNo 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 precancerous form of blood cancer that affects the bone marrow. The study is investigating the effects of a treatment called daratumumab, which is administered through an injection under the skin, also known as subcutaneous use. The purpose of the study is to determine if this treatment can help delay the progression of the disease compared to simply monitoring the condition without active treatment.

Participants in the study will receive either the daratumumab treatment or be placed under active monitoring. Active monitoring means that the health of the participants will be regularly checked without giving them the study medication. The study will observe how the body absorbs, distributes, and eliminates the drug, which is known as pharmacokinetics. The trial will last for a period of time, during which participants will be closely monitored to assess the safety and effectiveness of the treatment.

The main goal is to see if daratumumab can prolong the time before the disease progresses to a more serious form, known as multiple myeloma. This is referred to as progression-free survival. The study will help researchers understand if this treatment can offer a better outcome for patients with high-risk smoldering multiple myeloma compared to not receiving the 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

    Joining the study

    Upon joining the study, the patient will be informed about the purpose and procedures of the trial. An informed consent form must be signed to confirm understanding and willingness to participate.

    Eligibility criteria include being at least 18 years old, having a diagnosis of high-risk smoldering multiple myeloma, and meeting specific medical conditions and laboratory values.

  2. Step 2

    Randomization

    The patient will be randomly assigned to one of two groups: the daratumumab treatment group or the active monitoring group.

    Randomization ensures that each participant has an equal chance of being assigned to either group.

  3. Step 3

    Treatment phase

    If assigned to the daratumumab group, the patient will receive the medication through subcutaneous injection. The dosage and frequency will be determined by the study protocol.

    The treatment aims to prolong the time before the disease progresses.

  4. Step 4

    Active monitoring

    If assigned to the active monitoring group, the patient's condition will be regularly checked without receiving the daratumumab treatment.

    Monitoring involves regular assessments to track any changes in the patient's condition.

  5. Step 5

    Follow-up

    Throughout the study, the patient's health and response to treatment or monitoring will be closely observed.

    The study will continue until the estimated end date in December 2025, or until the disease progresses or other criteria are met.

Who can join the trial?

14 criteria

  • Must be at least 18 years old or the legal age of consent, whichever is older.
  • Must be willing and able to follow the rules and restrictions of the study.
  • Must have been diagnosed with smoldering multiple myeloma (SMM), a type of blood condition, for 5 years or less, with measurable disease. This means having certain levels of specific proteins in the blood or urine.
  • Must have at least 10% bone marrow plasma cells (BMPCs), which are a type of cell in the bone marrow, and meet at least one of the following conditions:
    • Serum M protein level of 30 grams per liter or more.
    • Having a specific type of SMM called Immunoglobulin A (IgA) SMM.
    • Having a reduction in two types of immune proteins, known as immunoparesis.
    • A specific ratio of proteins in the blood, called the serum involved: uninvolved FLC ratio, between 8 and less than 100.
    • Having a certain percentage of clonal BMPCs, which are abnormal cells in the bone marrow, between 50% and less than 60% with measurable disease.
    • Must have an ECOG performance status score of 0 or 1, which indicates the level of daily functioning.
    • Must have certain clinical laboratory values before treatment, as specified in the study protocol.
    • Must sign an informed consent form (ICF), or have a legally acceptable representative sign, to show understanding and willingness to participate in the study.
    • Must follow local regulations for contraceptive use. Women who can become pregnant must agree to either not have heterosexual intercourse or use a highly effective form of birth control, starting 4 weeks before the study treatment.
    • Women who can become pregnant must have a negative pregnancy test within 14 days before starting the study.
    • During the study and for 3 months after the last dose of the study drug, women must agree not to donate eggs for assisted reproduction.

Who cannot join the trial?

1 criterion

  • Patients with a precancerous form of blood cancer in the bone marrow cannot participate. This means a condition where the bone marrow, which is the soft tissue inside bones that makes blood cells, shows early signs of cancer.
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Investigated drugs

Daratumumab is a medication used in this clinical trial to treat patients with high-risk smoldering multiple myeloma. It is administered under the skin, which is known as subcutaneous administration. The goal of using daratumumab in this study is to see if it can help delay the progression of the disease compared to just monitoring the condition without active treatment.

What is already known about the treatment

Daratumumab – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness in treating high-risk smoldering multiple myeloma, a precancerous condition affecting the bone marrow. Daratumumab is primarily used to prolong progression-free survival in patients with this condition. It works by targeting a specific protein on the surface of certain blood cells, helping the immune system to identify and destroy these cells. Daratumumab is classified as a monoclonal antibody, a type of medication that specifically targets and binds to proteins on cancer cells.

Investigated diseases

Smoldering Multiple Myeloma – Smoldering multiple myeloma is a precancerous condition affecting the blood and bone marrow. It is characterized by an abnormal increase in plasma cells, which are a type of white blood cell. These cells can produce a protein that may be detected in the blood or urine. Unlike active multiple myeloma, smoldering multiple myeloma does not cause symptoms or organ damage. However, it has the potential to progress to active multiple myeloma over time. Monitoring is essential to detect any changes that might indicate progression to a more serious condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507143-11-00Protocol code54767414SMM3001Estimated enrolment336 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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