Not recruiting

Study on Isatuximab, Pomalidomide, Dexamethasone, and Carfilzomib for Patients with Relapsed or Refractory Multiple Myeloma

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 condition called Multiple Myeloma, which is a type of cancer that affects plasma cells in the bone marrow. The study is testing a combination of treatments to see how effective they are in patients whose disease has returned or is not responding to previous treatments. The treatments being studied include Isatuximab, Pomalidomide, Dexamethasone, and Carfilzomib. Isatuximab is a type of protein that targets cancer cells, Pomalidomide and Dexamethasone are medications that help control the immune system and inflammation, and Carfilzomib is a drug that helps stop cancer cells from growing.

The purpose of this study is to determine how well these treatments work together in treating Multiple Myeloma. Participants in the study will receive these medications in different forms, such as tablets, capsules, or infusions, over a period of time. The study will monitor the participants' response to the treatment and any side effects they may experience. The goal is to find out if this combination of treatments can help control the disease and improve the quality of life for patients.

Throughout the study, participants will have regular check-ups to assess their health and the progress of the treatment. The study will also look at how long the treatment effects last and how it impacts the overall survival of the participants. This research aims to provide valuable information that could lead to better treatment options for people with Multiple Myeloma in the future.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.
Blood tests and other diagnostic procedures may be performed to ensure all criteria are met.
Step 2
Treatment initiation
The treatment phase begins with the administration of medications. The primary drugs used in this study are isatuximab, pomalidomide, dexamethasone, and carfilzomib.
Isatuximab is given through an intravenous infusion. Pomalidomide is taken orally in capsule form. Dexamethasone is also administered orally. Carfilzomib is provided via intravenous infusion.
Step 3
Medication schedule
The specific dosage and frequency of each medication are determined by the study protocol and may vary based on individual response and tolerance.
Regular monitoring is conducted to assess the effectiveness and any side effects of the treatment.
Step 4
Ongoing monitoring
Throughout the study, regular visits are scheduled to monitor health status and treatment response.
Blood tests and other assessments are performed to track progress and adjust treatment as necessary.
Step 5
Response evaluation
The response to treatment is evaluated using specific criteria to determine the effectiveness of the therapy.
This includes measuring the reduction in disease markers and assessing overall health improvements.
Step 6
Study completion
Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response and any long-term effects.
Participants may be asked to attend follow-up visits to monitor health status after the study ends.

Who can join the trial?

15 criteria

Must be able to understand and voluntarily sign an informed consent form.
Must be able to follow the study visit schedule and other study requirements.
Must be male or female, aged 18 years or older.
Must have a life expectancy of more than 6 months.
Must be in early stages of relapse for **Multiple Myeloma**, having had 1 to 2 previous treatments, and must have received a specific treatment called **Lenalidomide** for at least 2 cycles.
Must have a measurable disease, which means having a detectable and quantifiable protein in the blood or urine.
Must have a performance status score of 0, 1, or 2, which indicates the ability to carry out daily activities.
Must have a break of at least 28 days without **Multiple Myeloma** treatment before starting the study, except for a specific treatment called anti CD-38.
Must have adequate bone marrow function, which means having enough blood cells without recent transfusions or growth factor support.
Must have adequate organ function, which includes specific levels of liver and kidney function.
Must be part of an appropriate social security system.
Men who are sexually active with a pregnant woman or a woman who can become pregnant must agree to use a barrier method of birth control, like a condom, and must not donate sperm during the study and for 5 months after stopping treatment.
Women who can become pregnant must agree to use two reliable methods of birth control before, during, and after the study for at least 5 months.
All patients must agree not to donate blood during the study and for at least 5 months after the last dose of treatment.
All patients must understand and agree to follow the conditions of a specific pregnancy prevention plan related to the study.

Who cannot join the trial?

6 criteria

Patients who have a different type of cancer other than Multiple Myeloma cannot participate. Multiple Myeloma is a type of blood cancer that affects plasma cells.
Patients who are not experiencing an early relapse or whose disease is not resistant to treatment cannot participate. A relapse means the cancer has returned after treatment, and refractory means the cancer does not respond to treatment.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are not part of the specified clinical trial group cannot participate. This group is determined by specific medical criteria.
Both male and female patients are eligible, but those who do not meet other criteria cannot participate.
Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes individuals who may have difficulty giving informed consent or are at higher risk of harm.

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Verified sites

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

CHU Grenoble Alpes
Verified
La Tronche, France
Centre Hospitalier De La Cote Basque
Verified
Bayonne, France
Centre Hospitalier Regional Universitaire De Tours
Verified
Tours, France

Trial locations

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Investigated drugs

Isatuximab
is a medication used in the treatment of multiple myeloma, a type of blood cancer. It works by targeting and attaching to a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells.
Pomalidomide
is a medication that helps to slow down or stop the growth of cancer cells in multiple myeloma. It also helps the immune system to fight the cancer by enhancing the body's natural defenses.
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 reduce the activity of the disease and manage symptoms.
Carfilzomib
is a medication used to treat multiple myeloma by blocking the action of proteasomes, which are structures inside cells that break down proteins. By inhibiting proteasomes, carfilzomib causes an accumulation of proteins in cancer cells, leading to their death.

What is already known about the treatment

Isatuximab
Isatuximab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, particularly in cases where the disease has relapsed or is resistant to other treatments. It is a monoclonal antibody that targets a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. Isatuximab is classified as an anti-cancer agent and is part of a combination therapy aimed at improving patient outcomes in multiple myeloma.
Pomalidomide
Pomalidomide is taken orally and is used in combination with other medications to treat multiple myeloma, especially in patients who have not responded to previous treatments. It works by modulating the immune system and inhibiting the growth of cancer cells. Pomalidomide is classified as an immunomodulatory drug and is an important part of combination therapies for managing multiple myeloma.
Dexamethasone
Dexamethasone is an oral medication that is used in combination with other drugs to treat multiple myeloma. It is a corticosteroid that helps reduce inflammation and suppresses the immune response, which can be beneficial in controlling cancer growth. Dexamethasone is classified as an anti-inflammatory and immunosuppressant, playing a supportive role in cancer treatment regimens.
Carfilzomib
Carfilzomib is administered intravenously and is used in combination with other medications to treat multiple myeloma, particularly in patients who have relapsed or are resistant to other treatments. It works by inhibiting proteasomes, which are enzyme complexes that break down proteins in cells, leading to cancer cell death. Carfilzomib is classified as a proteasome inhibitor and is a key component in combination therapies for multiple myeloma.

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 due to the impact on various organs and systems in the body.