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Study on Dexamethasone for Patients with Advanced Relapsed or Refractory 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 Multiple Myeloma, a type of cancer that affects certain cells in the bone marrow. The study is investigating the use of Dexamethasone, a medication that can be taken as an oral solution, tablet, or through injection, as an initial treatment for patients with advanced stages of this disease. The purpose of the study is to determine how well patients respond to this treatment after several cycles.

Participants in the study will receive Dexamethasone in one of its available forms, and their progress will be monitored over a period of time. The study aims to see if the treatment can help achieve a significant response in patients, which means either a complete or partial reduction of the disease symptoms. The study is designed to compare the effectiveness of Dexamethasone with other treatment options available for Multiple Myeloma.

The trial will involve several cycles of treatment, and the response of the patients will be assessed using specific criteria set by experts in the field. This study is important for understanding how Dexamethasone can be used effectively in treating Multiple Myeloma and may provide valuable insights into improving treatment strategies for this condition.

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

    Joining the study

    Upon joining the study, the patient will be informed about the trial's objectives and procedures. The patient must provide signed informed consent to participate.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes verifying a diagnosis of multiple myeloma in relapse and ensuring the patient has received between 1 to 3 prior therapies for multiple myeloma.

  3. Step 3

    Treatment regimen

    The patient will receive a free regimen of dexamethasone as initial therapy. Dexamethasone can be administered orally, intramuscularly, or intravenously, depending on the specific treatment plan.

  4. Step 4

    Treatment cycles

    The treatment consists of six cycles of salvage therapy. The patient's response to the treatment will be assessed using the International Myeloma Working Group criteria.

  5. Step 5

    Response evaluation

    The primary goal is to determine the overall response rate after six cycles. This includes evaluating the proportion of patients who achieve a complete or partial response.

  6. Step 6

    Completion of trial

    The trial is estimated to end by June 30, 2028. The patient's participation will conclude after the final assessment of their response to the treatment.

Who can join the trial?

9 criteria

  • Must be an adult, which means you need to be at least 18 years old.
  • Must have a confirmed diagnosis of Multiple Myeloma that has come back after treatment. Multiple Myeloma is a type of cancer that affects certain blood cells in the bone marrow.
  • Must have received between 1 to 3 previous treatments for Multiple Myeloma. A treatment counts if it included at least 2 cycles of therapy.
  • Must be eligible for one of the following approved treatment combinations:
    • ICARIA schema: includes the drugs isatuximab, pomalidomide, and dexamethasone.
    • IKEMA schema: includes the drugs isatuximab, carfilzomib, and dexamethasone.
    • Must have shown improvement (at least a partial response) to the last treatment received.
    • Must have an ECOG Performance Status score of 0, 1, or 2. This score is a way to measure how well you can perform daily activities. A score of 0 means fully active, 1 means some symptoms but still able to do light work, and 2 means unable to work but can take care of yourself.
    • If you had side effects from previous treatments, they must be resolved or stable. This includes issues like peripheral neuropathy, which is a condition that causes numbness or tingling in the hands and feet.
    • Must provide a signed informed consent, which means you agree to participate in the study after being informed about all the details.

Who cannot join the trial?

3 criteria

  • Patients who have a different type of cancer other than Multiple Myeloma. Multiple Myeloma is a type of cancer that affects certain cells in the bone marrow.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Dexamethasone is a medication used in this trial as an initial therapy for patients with advanced relapsed or refractory multiple myeloma. It is a type of corticosteroid that helps reduce inflammation and suppresses the immune system, which can be beneficial in treating certain types of cancer, including multiple myeloma. In this study, it is being used to evaluate its effectiveness in improving the overall response rate in patients undergoing salvage therapy.

What is already known about the treatment

Dexamethasone – Dexamethasone is administered orally or intravenously, depending on the specific treatment protocol. It is currently well-established in medical literature as a treatment for various conditions, including multiple myeloma, a type of cancer affecting plasma cells in the bone marrow. The main therapeutic indication for dexamethasone in this context is to manage and treat advanced relapsed or refractory multiple myeloma. At the molecular level, dexamethasone works by binding to glucocorticoid receptors, which leads to the suppression of inflammation and modulation of immune responses. It is classified pharmacologically as a corticosteroid, which is a type of steroid hormone used to reduce inflammation and suppress the immune system.

Investigated diseases

Multiple Myeloma – Multiple myeloma is a type of 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 accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. As the disease progresses, it can cause bone pain, fractures, and anemia due to the disruption of normal blood cell production. Patients may also experience kidney problems and increased susceptibility to infections. The disease often progresses slowly, but it can become more aggressive over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510981-18-00Protocol codeAPHP231089Estimated enrolment334 patientsSponsorAssistance Publique Hopitaux De Paris

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