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

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What is this study about?

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.

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

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

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

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)

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Metaxa Cancer Center Hospital Of Piraeus	Piraeus	Greece
Saint Savvas Oncology Hospital	Athens	Greece
General University Hospital Of Larissa	Larissa	Greece
University General Hospital Of Ioannina	Ioannina	Greece
Alexandra Hospital	Athens	Greece
General University Hospital Of Patras	Patras	Greece
University General Hospital Of Alexandroupoli	Alexandroupoli	Greece
Evangelismos S.A.	Athens	Greece
Tryeaclmie Cjises Hvpdoaqh	Thessaloniki	Greece

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	31.05.2022

Trial locations

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.

Investigated diseases:

Plasma cell myeloma

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.

Trial ID:

2024-516060-28-00

Protocol code:

EAE 115

NCT ID:

NCT05298683

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?