Study of Isatuximab with Lenalidomide and Dexamethasone for Elderly Patients (70+) with Newly Diagnosed Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a blood cancer called multiple myeloma, which affects the plasma cells in the bone marrow. The study is specifically for elderly patients aged 70 years and older who have been newly diagnosed with this condition. The trial will compare two treatment approaches. One group will receive a combination of three medications: isatuximab, lenalidomide, and dexamethasone. The other group will receive only lenalidomide and dexamethasone. Isatuximab, also known by its code name SAR650984, is a type of medication called a monoclonal antibody, which is designed to target and destroy cancer cells. Lenalidomide and dexamethasone are commonly used drugs in treating multiple myeloma, with lenalidomide helping to slow the growth of cancer cells and dexamethasone reducing inflammation and swelling.

The purpose of this study is to determine if adding isatuximab to the treatment plan can improve outcomes for patients. The trial will involve an initial treatment phase followed by a maintenance phase. During the initial phase, patients will receive their assigned treatment regimen, and the effectiveness of the treatments will be assessed. After this phase, patients will continue with a maintenance treatment to help keep the cancer under control. The study will monitor various outcomes, including how well the cancer responds to treatment and the overall health and quality of life of the participants.

Throughout the study, researchers will evaluate the safety of the treatments and how well patients tolerate them. The trial aims to provide valuable information on whether the addition of isatuximab can lead to better results for patients with newly diagnosed multiple myeloma. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the study.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive a combination of isatuximab, lenalidomide, and dexamethasone, while the other group will receive only lenalidomide and dexamethasone.

The purpose of this study is to evaluate the effectiveness of adding isatuximab to the treatment regimen for patients with newly diagnosed multiple myeloma.

2 treatment phase

If you are in the group receiving isatuximab, it will be administered through an intravenous infusion. This means the medication will be given directly into your vein.

The dosage of isatuximab is 20 mg/mL, and it will be given as part of a solution for infusion.

You will also receive lenalidomide and low-dose dexamethasone. The specific dosages and frequency of these medications will be determined by the study protocol and your healthcare provider.

3 maintenance therapy

After the initial treatment phase, you will enter a maintenance therapy phase. If you were in the isatuximab group, you will continue to receive isatuximab and lenalidomide.

The goal of maintenance therapy is to help maintain the benefits achieved during the initial treatment phase.

4 monitoring and assessments

Throughout the study, regular monitoring and assessments will be conducted to evaluate your response to the treatment.

These assessments may include blood tests, imaging studies, and other evaluations to monitor the status of your multiple myeloma and overall health.

5 end of study

The study is expected to conclude by April 2028. At the end of the study, the results will be analyzed to determine the effectiveness of the treatment regimens.

Your participation in the study will contribute to understanding the potential benefits of adding isatuximab to the treatment of multiple myeloma.

Who Can Join the Study?

Age must be 70 years or older.
Must be able to provide written informed consent, which means you agree to participate in the study after being fully informed about it.
Must have newly diagnosed, symptomatic multiple myeloma, a type of blood cancer, with measurable disease. This means:
- Serum M protein (a type of protein in the blood) must be 0.5 g/dL or higher.
- Urine M protein must be 200 mg/24 hours or higher.
- If M protein is not detectable in blood or urine, serum free light chain (SFLC) must be 100 mg/L or higher with an abnormal FLC ratio.
No prior treatment for multiple myeloma.
Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2, which is a scale used to assess how a disease affects daily living abilities.
If at cardiac risk (heart-related issues), a baseline ECHO (heart ultrasound) is required, and the heart’s left ventricular ejection fraction (LVEF) must be more than 40%.
Must have adequate organ and bone marrow function within 21 days before starting the study, defined by:
- Bilirubin (a liver function marker) less than 2 times the upper limit of normal (ULN).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (liver enzymes) less than 3 times the ULN.
- Absolute neutrophil count (ANC, a type of white blood cell) must be 750/mm³ or higher.
- Hemoglobin (a protein in red blood cells) must be more than 8.0 g/dL.
- Platelet count (cells that help with blood clotting) must be more than 50,000/mm³.
- Creatinine clearance (a measure of kidney function) must be 30 mL/min or higher.

Who Cannot Join the Study?

Patients who have had another type of cancer in the past, unless it was a type of skin cancer called basal cell carcinoma or a type of cervical cancer called carcinoma in situ, which have been successfully treated.
Patients who have a serious infection that requires treatment with antibiotics, antifungals, or antivirals.
Patients who have a history of severe allergic reactions to any of the drugs used in the study.
Patients who have a condition called uncontrolled high blood pressure, which means their blood pressure is not well managed with medication.
Patients who have a condition called uncontrolled diabetes, which means their blood sugar levels are not well managed with medication.
Patients who have a condition called heart failure, which means their heart is not pumping blood as well as it should.
Patients who have had a heart attack or stroke in the past 6 months.
Patients who have a condition called active hepatitis, which is an inflammation of the liver.
Patients who have a condition called HIV infection, which affects the immune system.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Noe LGA Gesundheit Region Mitte GmbH	St. Poelten	Austria
SCRI CCCIT Ges.m.b.H.	Salzburg	Austria
Universitaetsklinikum Krems	Krems An Der Donau	Austria
Allgemein Oeffentliches Bezirkskrankenhaus Kufstein	Kufstein	Austria
Evangelismos S.A.	Athens	Greece
Alexandra Hospital	Athens	Greece
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse	Vienna	Austria
Stadt Wien Wiener Gesundheitsverbund	Vienna	Austria
Aabi Kwlkqnwrfvh Sqj Viajzlr Bvjjyrgz Giht	Zams	Austria
Sejoqqybvycxpfyr Kqkplrzdyakqyrcs Gsbxbnhdzi	Leoben	Austria
Tawujvwcmu Cymnjr Hsuezljy	Thessaloniki	Greece
Knrqyxi Djk Bkuzcgnidcqz Bignwwk	Linz	Austria

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	20.10.2021
Greece	Not recruiting	20.10.2021

Trial locations

Investigated drugs:

Isatuximab

Isatuximab is a type of medication known as a monoclonal antibody. It works by targeting and attaching to a specific protein found on the surface of cancer cells. This helps the body’s immune system to recognize and destroy these cancer cells. In this trial, isatuximab is being tested to see if it can help improve treatment outcomes for patients with newly diagnosed multiple myeloma when used in combination with other medications.

Lenalidomide is a medication that helps the immune system fight cancer. It works by stopping the growth of cancer cells and by helping the immune system to attack them. Lenalidomide is often used to treat multiple myeloma and is being used in this trial to see how well it works with other treatments to improve patient outcomes.

Dexamethasone is a type of steroid medication that helps reduce inflammation and suppresses the immune system. In cancer treatment, it is often used to help reduce the side effects of chemotherapy and to help improve the effectiveness of other cancer treatments. In this trial, dexamethasone is used in combination with other medications to treat multiple myeloma.

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. As the disease progresses, abnormal plasma cells multiply and accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. This can result in symptoms such as bone pain, fractures, fatigue, and increased susceptibility to infections. Over time, the accumulation of these abnormal cells can cause damage to the kidneys and other organs. The disease often progresses in a series of phases, starting with a smoldering or asymptomatic phase, followed by active disease and potentially leading to more aggressive forms. The progression can vary significantly among individuals, with some experiencing slow advancement and others facing rapid deterioration.

Trial ID:

2024-515581-13-00

Protocol code:

AGMT_MM-4

NCT ID:

NCT04891809

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Isatuximab with Lenalidomide and Dexamethasone for Elderly Patients (70+) with Newly Diagnosed Multiple Myeloma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?