Not recruitingRare disease

Study of Isatuximab, Pomalidomide and Dexamethasone combination for multiple myeloma patients who previously received Lenalidomide and Proteasome Inhibitor therapy

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 study focuses on patients with Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The research examines a combination treatment using three medications: isatuximab (given through intravenous infusion), pomalidomide (taken as oral capsules), and dexamethasone (which can be taken orally or given intravenously). This treatment is specifically intended for patients who have previously received one course of therapy that included lenalidomide and a proteasome inhibitor.

The main purpose of this research is to evaluate how well patients respond to this three-drug combination during the first six months of treatment. The study will measure how the disease responds to treatment and track the overall health outcomes of participants. Patients will receive treatment for up to 42 months, depending on how well they respond to the medications.

During the study, doctors will regularly monitor patients' blood counts, kidney and liver function, and assess how well the treatment is working. They will also track any side effects that may occur during treatment. After completing treatment, patients will continue to have follow-up visits to monitor their long-term health status.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your eligibility for the study will be evaluated based on specific medical criteria
Laboratory tests will check your bone marrow and liver function
Your current health status will be assessed using the ECOG Performance Status scale
Step 2
Treatment cycle begins
You will receive a combination of three medications:
Isatuximab - given through intravenous infusion
Pomalidomide - taken by mouth
Dexamethasone - taken by mouth in low doses
Step 3
Regular monitoring
Your response to treatment will be regularly evaluated
Blood tests will be performed to measure the levels of M-protein in your blood
The effectiveness of the treatment will be assessed after 6 months
Any side effects will be monitored and recorded
Step 4
Treatment continuation
Treatment will continue until one of the following occurs:
Disease progression is detected
Unacceptable side effects develop
The study reaches its end date (October 31, 2026)
Step 5
Follow-up period
After completing treatment, you will be monitored for 30 days to check for any side effects
Long-term follow-up visits will track your overall survival

Who can join the trial?

7 criteria

Must be at least 18 years old and able to provide informed consent
Must have received only one previous treatment for multiple myeloma that included: - At least 2 cycles of lenalidomide (a cancer medication) - A proteasome inhibitor (a type of cancer drug that blocks protein breakdown in cancer cells)
Must have measurable disease shown by at least one of these: - Specific protein level in blood of ≥0.5 g/dL - Specific protein level in urine of ≥200 mg/24 hours - Specific blood protein chain levels ≥10 mg/dL with abnormal ratio
Must have evidence that the disease has progressed after the last treatment
Must have adequate blood test results including: - Sufficient white blood cells (neutrophils ≥1.0 x 109/L) - Hemoglobin level ≥7.5 g/dL - Adequate platelet count - Liver function tests within acceptable limits - Kidney function showing creatinine clearance ≥30 mL/min - Calcium levels within specified limits
Must have a performance status of ECOG 2 or better (able to carry out most daily activities)
Any side effects from previous treatments must be resolved or reduced to mild level

Who cannot join the trial?

16 criteria

Age below 18 years old
Previous treatment with pomalidomide (a type of cancer medication)
Known allergic reaction to any of the study medications
Active or untreated cancer that has spread to the brain
Severe kidney problems (creatinine clearance less than 30 mL/min)
Severe liver problems
Active or chronic infections including:
- Hepatitis B
- Hepatitis C
- HIV
- Pregnancy or breastfeeding
- Unable to take blood-thinning medications
- Major surgery within 4 weeks before starting the study
- Participation in other clinical trials within 4 weeks before this study
- Serious heart conditions or uncontrolled high blood pressure
- History of other cancers within the past 3 years (except for successfully treated skin cancer or early-stage cancer)
- Mental health conditions that could interfere with study participation

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Verified sites

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

Alexandra Hospital
Verified
Athens, Greece
Theageneio Cancer Hospital
Verified
Thessaloniki, Greece
University General Hospital Of Alexandroupoli
Verified
Alexandroupoli, Greece

Trial locations

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Investigated drugs

Isatuximab is a medication that targets specific proteins on cancer cells to help fight multiple myeloma. It works by helping your immune system identify and attack cancer cells more effectively. Pomalidomide is a medication that helps treat multiple myeloma by working in several ways. It helps strengthen your immune system's ability to fight cancer cells and may also prevent the growth of new blood vessels that feed tumors. Dexamethasone is a corticosteroid medication that helps reduce inflammation in the body. In multiple myeloma treatment, it works together with other medications to make them more effective and can help manage certain symptoms of the disease. Lenalidomide is a medication previously used by the patients in this study. It works similarly to pomalidomide by helping the immune system fight cancer cells and blocking blood vessel growth to tumors. Proteasome Inhibitors (previously used by the patients in this study) are a class of medications that work by blocking certain proteins that cancer cells need to survive, helping to slow or stop the growth of multiple myeloma cells.

What is already known about the treatment

Isatuximab
A monoclonal antibody medication administered through intravenous infusion, specifically designed for treating multiple myeloma. It works by targeting the CD38 protein found on the surface of myeloma cells, helping the immune system to identify and destroy these cancer cells. This medication belongs to the class of targeted immunotherapy drugs and is typically used in combination with pomalidomide and dexamethasone for patients who have received prior treatment with lenalidomide and proteasome inhibitors.
Pomalidomide
An oral immunomodulatory drug taken in capsule form, used in the treatment of multiple myeloma. It works by enhancing the immune system's response against cancer cells while also preventing the growth of new blood vessels that support tumor growth. This medication belongs to the class of immunomodulatory agents and is commonly used in combination therapy for patients who have received at least one prior treatment regimen.
Dexamethasone
A synthetic corticosteroid medication that can be taken orally or administered intravenously, used in multiple myeloma treatment to reduce inflammation and suppress immune system activity. It works by decreasing the body's immune response and reducing inflammation, which helps to control myeloma cell growth. This medication belongs to the glucocorticoid class and is frequently used in combination with other anti-myeloma treatments to enhance their effectiveness.

Investigated diseases

Multiple Myeloma - A type of blood cancer that develops in plasma cells, which are white blood cells that help fight infection. In this condition, cancerous plasma cells accumulate in the bone marrow and crowd out healthy blood cells. These abnormal cells produce large amounts of defective antibodies that build up in the body. The disease can weaken bones and affect the body's ability to make healthy blood cells. Multiple myeloma typically develops gradually and can affect various parts of the body, particularly the bones, kidneys, and immune system. The condition often causes fatigue, bone pain, and increased susceptibility to infections.