Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Study on Melflufen and Dexamethasone for Elderly Patients with Relapsed Multiple Myeloma

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 called Relapsed Multiple Myeloma, which is a type of blood cancer that returns after treatment. The study will explore the effectiveness of a treatment combination involving two medications: Melflufen and Dexamethasone. Melflufen is a type of chemotherapy drug, while Dexamethasone is a steroid that helps reduce inflammation and is often used to treat various conditions, including cancer.

The purpose of the study is to evaluate how well this combination works in elderly patients who have experienced a second or further relapse of their multiple myeloma. Participants in the study will receive either the treatment combination or a placebo. The study will monitor the participants over a period of time to see how their condition responds to the treatment. The treatment will be administered either orally or through an intravenous infusion, depending on the specific medication.

Throughout the study, researchers will track the overall response rate, which means they will look at how many participants show improvement in their condition. They will also observe how long the response lasts, the time it takes for the disease to progress, and the overall survival of the participants. The study aims to provide valuable information on the potential benefits of using Melflufen and Dexamethasone together for treating relapsed multiple myeloma in elderly patients.

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

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Eligibility criteria include age between 70 and 85 years, previous treatment for multiple myeloma, and specific health parameters such as liver and kidney function.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of melphalan flufenamide and dexamethasone.

    Melphalan flufenamide is given as an intravenous infusion. The specific dosage and frequency are determined by the study protocol.

    Dexamethasone is administered orally in the form of drops. The dosage and frequency are also specified in the study protocol.

  3. Step 3

    Ongoing monitoring

    Regular monitoring is conducted to assess the response to treatment. This includes blood tests and other assessments to evaluate the effectiveness and safety of the treatment.

    The primary goal is to measure the overall response rate, which includes any improvement in the condition as defined by specific criteria.

  4. Step 4

    Response evaluation

    The duration of response is evaluated, which is the time from the first documented improvement to any progression of the disease.

    Progression-free survival is also assessed, which is the time from the start of treatment to any progression of the disease or death.

  5. Step 5

    Study completion

    The study is estimated to conclude by August 2027. At the end of the study, a final assessment is conducted to evaluate the overall survival and time to response.

    Participants' data will be analyzed to determine the effectiveness of the treatment in managing relapsed multiple myeloma.

Who can join the trial?

20 criteria

  • Patients must have **relapsed multiple myeloma**, which means the disease has returned after treatment.
  • The disease must have progressed or relapsed after receiving 2 or more previous treatments.
  • Patients need to have **adequate liver function**, which includes:
    • Total bilirubin level no more than 1.5 times the upper limit of normal (ULN).
    • AST (a liver enzyme) level no more than 2.5 times the ULN.
    • ALT (another liver enzyme) level no more than 2.5 times the ULN.
    • Patients must have an **estimated creatinine clearance** of at least 30 mL/min. This measures how well the kidneys are working.
    • Patients need to have **adequate bone marrow function**, which includes:
      • Absolute neutrophil count of at least 1.0 × 109/L. Neutrophils are a type of white blood cell.
      • Platelet count of at least 50 × 109/L. Platelets help with blood clotting.
      • Hemoglobin level of at least 8 g/dL. Hemoglobin is a protein in red blood cells that carries oxygen.
      • Non-vasectomized male patients must agree to use appropriate birth control methods.
      • Patients must be willing and able to attend study visits and follow the study procedures.
      • Patients must provide written informed consent, which means they agree to participate after understanding the study details.
      • Patients must have a life expectancy of at least 3 months.
      • Patients must have been previously treated with at least one drug from each of the following categories:
        • Anti-CD38 monoclonal antibodies (MoAbs)
        • Immunomodulatory drugs (IMiDs)
        • Proteasome inhibitors
        • Patients must be between 70 and 85 years old.
        • Patients must have an **ECOG performance status** of 2 or less. This is a scale that measures how well patients can perform daily activities.
        • Patients must have certain levels of **M-protein** in their blood or urine, which are markers of multiple myeloma.
        • Patients must have a **left ventricular ejection fraction (LVEF)** of at least 40%, as determined by a heart scan. This measures how well the heart pumps blood.

Who cannot join the trial?

4 criteria

  • Patients who have not experienced a relapse of their condition. A relapse means that the disease has returned after a period of improvement.
  • Patients who are not in their second or later relapse. This means the study is for those who have had the disease return at least twice.
  • Patients who are not considered elderly. The study is focused on older adults.
  • Patients who are part of a vulnerable population. This refers to groups who may need special protection, such as children or those unable to give consent.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Melflufen

    is a medication being studied for its effectiveness in treating elderly patients with multiple myeloma who have experienced a second or subsequent relapse. It is designed to target and destroy cancer cells more effectively by delivering a chemotherapy agent directly to the cancer cells.

  • Dexamethasone

    is a type of steroid medication used in this trial to help reduce inflammation and suppress the immune system. It is often used in combination with other cancer treatments to enhance their effectiveness and manage symptoms associated with cancer.

What is already known about the treatment

  • Melflufen

    Melflufen is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating relapsed multiple myeloma, particularly in elderly patients experiencing a second or subsequent relapse. It is not yet widely established in medical practice but is gaining attention in medical literature due to its potential benefits. The main therapeutic indication for melflufen is relapsed multiple myeloma. At the molecular level, melflufen works by delivering a cytotoxic agent directly into cancer cells, where it is activated to damage the DNA, leading to cell death. It is classified pharmacologically as an alkylating agent.

  • Dexamethasone

    Dexamethasone is taken orally or administered intravenously and is a well-established medication in the treatment of various inflammatory and autoimmune conditions, as well as certain types of cancer, including multiple myeloma. In the context of the clinical trial, it is used in combination with melflufen to enhance therapeutic effects. The main therapeutic indication for dexamethasone in this trial is relapsed multiple myeloma. It works by suppressing inflammation and modulating the immune response, which can help reduce cancer cell proliferation. Dexamethasone is classified as a corticosteroid.

Investigated diseases

Relapsed Multiple Myeloma – This is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. In relapsed multiple myeloma, the disease returns after a period of improvement or remission. The condition is characterized by the overproduction of abnormal plasma cells, which can crowd out healthy blood cells and lead to bone damage, kidney problems, and weakened immune function. As the disease progresses, patients may experience symptoms such as bone pain, fatigue, and frequent infections. The progression of relapsed multiple myeloma can vary, with periods of stability followed by periods of active disease.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IITrial ID2024-514652-33-00Protocol codeMELISSAEstimated enrolment30 patientsSponsorFondazione European Myeloma Network Italy O.N.L.U.S.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.