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Study on Isatuximab and CellProtect for Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma Eligible for Stem Cell Transplant

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 clinical trial is focused on studying a disease called Multiple Myeloma, which is a type of cancer that affects the blood. The study is testing two treatments: Isatuximab, also known by its code name SAR650984, and a treatment called CellProtect. Isatuximab is a medication given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. CellProtect is a type of cell therapy that involves using the patient's own cells, which are modified and then injected back into the body to help fight the cancer.

The purpose of this study is to see if combining Isatuximab with CellProtect is more effective than using Isatuximab alone in treating patients with newly diagnosed Multiple Myeloma who are eligible for a procedure called autologous stem cell transplantation. This procedure involves using the patient's own stem cells to help restore healthy blood cells after high-dose treatment. The study will compare the overall response rate, which is a measure of how well the cancer responds to the treatment, between the two groups of patients.

Participants in the study will receive either the combination of Isatuximab and CellProtect or Isatuximab alone. The study will last for a period of time, during which patients will receive regular treatments and check-ups to monitor their health and the effectiveness of the treatment. Some patients may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments being studied. The study aims to provide valuable information on the best way to treat Multiple Myeloma and improve patient outcomes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must provide written consent, acknowledging understanding of the trial and its procedures.
Eligibility is confirmed based on criteria such as age, health status, and specific medical conditions related to multiple myeloma.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the patient's health status, including physical examination, laboratory tests, and measurement of disease markers.
The patient's performance status is assessed using the Eastern Cooperative Oncology Group (ECOG) scale.
Step 3
Treatment allocation
The patient is randomly assigned to one of two treatment groups: one receiving Isatuximab alone, and the other receiving a combination of Isatuximab and CellProtect.
Both treatments are administered as intravenous infusions.
Step 4
Treatment administration
The patient receives Isatuximab as a 20 mg/mL solution for infusion. The frequency and duration of administration are determined by the study protocol.
If assigned to the combination group, the patient also receives CellProtect as a suspension for injection.
Step 5
Monitoring and follow-up
Regular monitoring is conducted to assess the patient's response to treatment, including laboratory tests, vital signs, and physical examinations.
The patient's overall response rate (ORR) is evaluated at specific visits to determine the effectiveness of the treatment.
Step 6
Completion of treatment
Upon completion of the treatment cycles, a final assessment is conducted to evaluate the patient's health status and response to the treatment.
The study aims to enhance the overall response rate and monitor any treatment-emergent adverse events.

Who can join the trial?

10 criteria

The patient must have **active multiple myeloma**, which is a type of blood cancer, as defined by specific medical guidelines.
The patient can be male or female. Female participants must not be pregnant or breastfeeding and must meet certain conditions regarding their ability to have children.
After a specific treatment called **high-dose treatment (HDT)**, the patient must meet additional criteria, including showing at least a partial improvement in their condition.
There must be evidence of the disease that can be measured, such as a certain level of a protein in the blood or urine.
If the disease cannot be measured by the usual proteins in blood or urine, a different test involving **serum immunoglobulin free light chains** must show specific results.
The patient must be newly diagnosed and considered for **high-dose chemotherapy**, which is a strong treatment for cancer.
The patient must provide written consent to participate in the study, understanding that they can withdraw at any time without affecting their medical care.
The patient must be at least 18 years old and meet the legal age of consent where the study is conducted.
The patient must have a certain level of physical ability, as measured by a score called the **Eastern Cooperative Oncology Group (ECOG) performance status**, which should be 0, 1, or 2.
Male participants must agree to use contraception during the study and for at least 5 months after the last dose of the study treatment. They must also agree not to donate sperm during this period.

Who cannot join the trial?

5 criteria

Patients who have a different type of cancer other than multiple myeloma cannot participate. Multiple myeloma is a type of cancer that affects certain cells in the bone marrow.
Patients who are not eligible for autologous stem cell transplantation (ASCT) cannot participate. ASCT is a procedure where a patient's own stem cells are used to replace damaged or destroyed bone marrow.
Patients who have not received high dose treatment (HDT) cannot participate. HDT involves giving high doses of chemotherapy to kill cancer cells.
Patients who are not newly diagnosed with multiple myeloma cannot participate. This means the study is only for those who have recently found out they have this condition.
Patients who are not considered part of the vulnerable population cannot participate. This refers to groups of people who might need special protection or care.

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Verified sites

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Karolinska University Hospital
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Solna, Sweden

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Investigated drugs

CellProtect
is a therapy being tested in combination with another medication to see if it can improve the response rate in patients with multiple myeloma. It is used as a maintenance treatment after patients have received high-dose treatment and are eligible for a stem cell transplant. The goal is to see if adding CellProtect can enhance the effectiveness of the treatment.
Isatuximab
is an antibody used in this trial to treat multiple myeloma. It is being tested both alone and in combination with CellProtect to determine its effectiveness as a maintenance treatment. The study aims to see if Isatuximab can help maintain the benefits of previous high-dose treatments in patients who are undergoing a stem cell transplant.

What is already known about the treatment

Isatuximab – Isatuximab is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, a type of blood cancer. The main therapeutic indication for Isatuximab is as a maintenance treatment for patients with multiple myeloma, particularly those who have undergone high-dose treatment and are eligible for stem cell transplantation. At the molecular level, Isatuximab works by targeting a specific protein on the surface of cancer cells, known as CD38, which helps the immune system to identify and destroy these cells. It is classified as a monoclonal antibody, a type of medication designed to target specific proteins in the body.

Investigated diseases

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. These cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones, kidneys, and the immune system. As the disease progresses, it can result in bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also lead to a decrease in the production of normal blood cells, causing fatigue and other related symptoms. Over time, the disease can cause significant complications, affecting various organs and systems in the body.