Study on the Effectiveness and Safety of Idecabtagene Vicleucel for Patients with Relapsed or Refractory Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying a type of blood cancer called multiple myeloma. Multiple myeloma is a condition where cancer cells build up in the bone marrow and crowd out healthy blood cells. The study is particularly interested in cases where the disease has returned after treatment, known as relapsed multiple myeloma, or when it does not respond to treatment, known as refractory multiple myeloma. The treatment being tested in this study is called idecabtagene vicleucel, also known by its code name bb2121. This treatment is a type of cell therapy, which involves using the patient’s own immune cells that are modified to better fight the cancer.

The purpose of the study is to evaluate how effective and safe bb2121 is for people with multiple myeloma that has either returned or not responded to previous treatments. In some cases, the study will also look at how well bb2121 works when used together with another medication called lenalidomide. Participants in the study will receive the treatment through an injection into a vein, known as an intravenous injection. The study will follow participants over time to see how their disease responds to the treatment and to monitor any side effects.

Throughout the study, researchers will collect information on how well the treatment works, including how long it takes for the disease to respond and how long the response lasts. They will also look at the overall health and quality of life of participants. The study aims to provide valuable information that could help improve treatment options for people with multiple myeloma in the future.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. The patient must sign an informed consent form to confirm understanding and agreement to participate.

2 screening and eligibility

The patient will undergo a series of tests to confirm eligibility. This includes checking the patient’s age, health status, and previous treatments. The patient must have adequate vascular access for a procedure called leukapheresis.

3 leukapheresis

Leukapheresis is a procedure to collect white blood cells from the patient. These cells will be used to create the personalized treatment, idecabtagene vicleucel.

4 treatment preparation

The collected cells are modified in a laboratory to target myeloma cells. This process takes several weeks.

5 conditioning therapy

Before receiving the modified cells, the patient will undergo conditioning therapy. This involves chemotherapy to prepare the body for the new cells.

6 administration of idecabtagene vicleucel

The patient will receive the modified cells, idecabtagene vicleucel, through an intravenous infusion. This is a one-time treatment.

7 monitoring and follow-up

After the infusion, the patient will be closely monitored for any side effects and the effectiveness of the treatment. Regular follow-up visits will be scheduled to assess the patient’s response and overall health.

8 long-term follow-up

The patient agrees to continue follow-up for up to 15 years. This is to monitor long-term effects and ensure safety.

Who Can Join the Study?

The person must be at least 18 years old when they sign the consent form.
Men must either not have sexual contact or use a condom during sexual contact with a pregnant woman or a woman who can have children, even if they have had a vasectomy. This must be done from the start of the study until at least one year after receiving a specific type of chemotherapy. They must also not donate any tissue, including sperm, blood, or organs, during this time.
For certain groups in the study, the person must have a measurable disease. This means having specific levels of proteins in the blood or urine that can be measured.
For one group, the person must have had at least three different treatments for their condition before. They must have received certain types of medications and shown signs that the disease got worse within 60 days of their last treatment. They must have responded to at least one previous treatment.
For another group, the person must have had only one previous treatment. They must have certain risk factors, like the disease getting worse within 18 months of starting their first treatment, which included specific medications and procedures.
The person must have a performance status of 1 or less on a scale used to measure how well they can perform daily activities.
The person must have recovered from any side effects of previous treatments to a certain level, except for hair loss and mild nerve damage.
The person must have good enough veins for a procedure called leukapheresis, which involves collecting white blood cells.
The person must understand and willingly sign a consent form before any study-related activities begin.
The person must be willing and able to follow the study schedule and other requirements, and agree to be followed up for up to 15 years as required by guidelines for gene therapy studies.
Women who can have children must have a negative pregnancy test before starting the study treatment. They must either not have sexual contact or use highly effective birth control methods from the start of the study until at least one year after receiving a specific type of chemotherapy. They must also not breastfeed or donate any tissue, including egg cells, blood, or organs, during this time.

Who Cannot Join the Study?

Patients who have had another type of cancer in the past, unless it was treated and has not come back for at least 5 years.
Patients with active infections that are not controlled or treated.
Patients who have had a heart attack or severe heart problems in the last 6 months.
Patients with severe lung problems that make it hard to breathe.
Patients with liver disease that is not controlled or treated.
Patients with kidney disease that is not controlled or treated.
Patients who are pregnant or breastfeeding.
Patients who have received another experimental treatment in the last 4 weeks.
Patients with a history of allergic reactions to similar treatments.
Patients with any other medical condition that the study doctors think would make it unsafe to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country	Status
Universitaetsklinikum Wuerzburg AöR	Wuerzburg	Germany
Centre Hospitalier Universitaire De Poitiers	Poitiers	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.09.2018
Germany	Not recruiting	01.09.2018
Spain	Not recruiting	01.09.2018

Trial locations

Investigated drugs:

Idecabtagene Vicleucel

BB2121 is a type of therapy used in this clinical trial for patients with multiple myeloma, a type of blood cancer. It is a form of treatment that involves modifying the patient’s own immune cells to better recognize and attack cancer cells. This therapy is being tested to see how well it works in patients whose cancer has returned or has not responded to previous treatments.

Lenalidomide is a medication used in combination with BB2121 in one part of the study. It is an oral drug that helps the immune system fight cancer and is often used to treat multiple myeloma. In this trial, it is used as a maintenance therapy to help keep the cancer from coming back after initial treatment with BB2121.

Investigated diseases:

Relapsed and Refractory Multiple Myeloma (RRMM) – This is a type of cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In RRMM, the disease returns after treatment or does not respond to standard therapies. It typically involves the accumulation of abnormal plasma cells in the bone marrow, leading to bone damage, anemia, and kidney issues. The disease can progress with symptoms such as bone pain, fatigue, and frequent infections. Over time, the cancerous cells can spread to other parts of the body, affecting overall health and organ function.

Multiple Myeloma (MM) – This is a cancer of plasma cells, which are responsible for producing antibodies in the immune system. In MM, cancerous plasma cells multiply uncontrollably in the bone marrow, leading to bone damage and impaired blood cell production. The disease often progresses with symptoms like bone pain, fatigue, and increased susceptibility to infections. As it advances, it can cause complications such as kidney damage and anemia. The progression of MM can vary, with periods of stability followed by active disease phases.

Newly Diagnosed Multiple Myeloma (NDMM) – This refers to the initial diagnosis of multiple myeloma in a patient who has not yet received treatment. NDMM involves the presence of cancerous plasma cells in the bone marrow, which can lead to bone lesions and other systemic symptoms. The disease may progress with signs such as bone pain, fatigue, and frequent infections. In some cases, NDMM may show a suboptimal response after initial treatments like autologous stem cell transplant. The progression can vary, with some patients experiencing rapid advancement while others have a slower disease course.

Trial ID:

2023-505183-10-00

Protocol code:

bb2121-MM-002

NCT ID:

NCT03601078

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of Idecabtagene Vicleucel for Patients with Relapsed or Refractory Multiple Myeloma

What is this study about?

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