Study on the Effectiveness and Safety of Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a condition called Multiple Myeloma, which is a type of cancer that affects plasma cells in the bone marrow. The study is specifically for patients who have been newly diagnosed with this disease. The treatment being tested is a combination of four medications: Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone. Isatuximab is given as a solution for infusion, which means it is administered directly into the bloodstream through a vein. Lenalidomide is provided in the form of hard capsules, Bortezomib is a powder that is mixed into a solution for injection, and Dexamethasone is available as tablets.

The purpose of this study is to evaluate how effective and safe this combination of medications is for treating Multiple Myeloma. Participants in the study will receive these medications over a period of time, and their health will be monitored to see how well the treatment works and to check for any side effects. The study will look at how many patients achieve a significant reduction in their cancer after two cycles of treatment, which is referred to as a “Very Good Partial Response” or better. This will help researchers understand the potential benefits of the treatment.

Throughout the study, participants will undergo regular health assessments to track their progress. The study will also gather information on the overall response to the treatment, the time it takes to see improvements, and the safety of the medication combination. This research aims to provide valuable insights into the treatment of Multiple Myeloma and improve outcomes for patients with this condition.

1 induction treatment

The induction phase involves a combination of medications to treat newly diagnosed multiple myeloma.

Medications include dexamethasone (2 mg tablets taken orally), bortezomib (1 mg powder for solution administered subcutaneously), lenalidomide (10 mg hard capsules taken orally), and isatuximab (solution for infusion administered intravenously).

The goal is to achieve a very good partial response or better by the end of two cycles.

2 maintenance therapy

Following the induction phase, maintenance therapy is administered to sustain the response.

Medications include lenalidomide in varying dosages (15 mg and 25 mg hard capsules taken orally).

The therapy aims to maintain the response achieved during induction and improve overall outcomes over one to two years.

3 assessment and monitoring

Throughout the trial, regular assessments are conducted to monitor the response to treatment.

These assessments include measuring the rate of very good partial response or better, complete response, and stringent complete response.

Safety and tolerability of the treatment regimen are also evaluated.

4 completion and follow-up

Upon completion of the treatment phases, follow-up assessments are conducted to evaluate long-term outcomes.

These include progression-free survival, overall survival, and duration of response.

The trial is estimated to conclude by June 2028.

Who Can Join the Study?

The patient must have been previously diagnosed with Multiple Myeloma (MM), which is a type of blood cancer, based on standard criteria and currently needs treatment.
The patient must provide voluntary written informed consent, which means they agree to participate in the study after understanding the details, and they can withdraw at any time without affecting their future medical care.
The patient must be between 18 and 75 years old. Patients over 70 need special approval.
The patient must have a measurable disease, which means having certain levels of specific proteins in the blood or urine that can be measured.
The patient must have certain laboratory test results, such as:
- ANC (a type of white blood cell count) of at least 1,000 cells/dL.
- Platelet count of at least 75,000 cells/dL if less than 50% of bone marrow cells are plasma cells, or at least 30,000 cells/dL if 50% or more are plasma cells.
- Total bilirubin level within 2 times the normal limit, except for patients with Gilbert Syndrome, who can have up to 3.0 mg/dL.
- AST and ALT (liver enzymes) within 3 times the normal limit.
- Hemoglobin level of at least 8g/dL.
- Calculated CrCl (a measure of kidney function) of at least 30 mL/min.
The patient must have an ECOG performance status of 2 or less, which is a scale that measures how well a patient can perform daily activities.
The patient must agree to join a mandatory Risk Management Programme for a medication called Lenalidomide and be willing to follow the programme’s requirements.
The patient must be able to understand and willing to sign a written informed consent document.
The patient must be considered eligible for ASCT (Autologous Stem Cell Transplant) by their doctor.

Who Cannot Join the Study?

Patients who have not been newly diagnosed with Multiple Myeloma cannot participate. 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 cannot participate. The age range is typically defined by the study organizers.
Patients who belong to a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who do not meet the specific health conditions or requirements set by the study cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
University Hospital Limerick	Limerick	Ireland
University Hospital Waterford	Waterford	Ireland
University Hospital Galway	Galway	Ireland
Region Midtjylland	Aarhus	Denmark
Beaumont Hospital	Dublin	Ireland
Mater Private Hospital	Dublin	Ireland

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	03.03.2022
Ireland	Not recruiting	03.03.2022

Trial locations

Investigated drugs:

Isatuximab is a medication used in this study to help treat multiple myeloma. It works by targeting and attaching to a specific protein on the surface of cancer cells, which helps the immune system to identify and destroy these cells.

Lenalidomide is a drug that helps to slow down or stop the growth of cancer cells. It also helps the immune system to attack cancer cells more effectively. It is commonly used in the treatment of multiple myeloma.

Bortezomib is a medication that interferes with the growth of cancer cells and is used to treat multiple myeloma. It works by blocking the action of proteasomes, which are structures inside cells that break down proteins. This can lead to the death of cancer cells.

Dexamethasone is a type of steroid that is used to reduce inflammation and suppress the immune system. In the context of multiple myeloma, it helps to enhance the effects of other cancer treatments and can also help to reduce some of the symptoms associated with the disease.

Investigated diseases:

Plasma cell myeloma

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this disease, abnormal plasma cells multiply and produce a large amount of a single type of antibody, which can cause damage to bones, kidneys, and the immune system. As the disease progresses, it can lead to symptoms such as bone pain, frequent infections, anemia, and kidney problems. The accumulation of these abnormal cells can form tumors in bones or soft tissues. Over time, the disease can cause significant damage to the skeletal system and other organs. It is a chronic condition that often requires ongoing management to control symptoms and progression.

Trial ID:

2024-512749-18-00

Protocol code:

CTRIAL-IE 19-34

NCT ID:

NCT05123131

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?