Not yet recruitingRare disease

Study on Dasatinib for Preventing Side Effects in Patients with Relapsed or Refractory Multiple Myeloma Receiving Idecabtagene Vicleucel Therapy

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 treatment for patients with relapsed or treatment-resistant multiple myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The study involves two medications: idecabtagene vicleucel and dasatinib. Idecabtagene vicleucel is a type of cell therapy where a patient's own T cells, a kind of white blood cell, are modified to better recognize and attack cancer cells. This therapy is known as CAR-T cell therapy. Dasatinib is a medication that is being tested to see if it can help prevent side effects associated with CAR-T cell therapy, specifically a condition called cytokine release syndrome (CRS), which can occur when the immune system becomes overly active.

The purpose of this study is to evaluate the safety and effectiveness of dasatinib in preventing CRS in patients receiving idecabtagene vicleucel therapy. Participants in the study will receive dasatinib as a preventive measure while undergoing treatment with idecabtagene vicleucel. The study will monitor the occurrence and severity of CRS and other potential side effects over a period of time. The trial will also assess how well patients respond to the treatment and their overall health outcomes.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to gather information on how the treatment affects their condition. The study aims to provide valuable insights into improving the management of side effects in patients undergoing CAR-T cell therapy for multiple myeloma.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initiation of treatment
The treatment begins with the administration of idecabtagene vicleucel, a therapy designed for patients with relapsed or treatment-resistant multiple myeloma. This is given as a dispersion for infusion, meaning it is delivered directly into the bloodstream through an intravenous line.
The infusion process is carefully monitored to ensure safety and effectiveness.
Step 2
Prophylactic medication
To prevent potential side effects associated with the infusion, dasatinib is administered. This medication is taken orally in the form of 140 mg film-coated tablets.
The purpose of dasatinib is to reduce the risk of cytokine release syndrome (CRS), a possible reaction to the therapy.
Step 3
Monitoring and assessment
Throughout the treatment, the frequency and severity of any side effects are closely monitored. This includes tracking any symptoms of CRS and other potential adverse effects.
The assessment period for these effects spans from the day of infusion (day 0) to day 30.
Step 4
Follow-up and evaluation
After the initial treatment phase, ongoing evaluations are conducted to assess the overall response to the therapy. This includes measuring the duration of response and progression-free survival.
The follow-up period extends up to 360 days post-treatment to ensure comprehensive monitoring of health outcomes and any long-term effects.

Who can join the trial?

8 criteria

The person must be **18 years or older** at the time of signing the consent form.
The person must understand the study, agree to participate, and sign the consent form before any study procedures begin.
The person must have a confirmed diagnosis of **RRMM** (a type of blood cancer) according to specific criteria.
The person must be eligible for a specific type of therapy called **CAR T therapy** with a product named **ide-cel**.
A production slot for the **ide-cel** therapy must be available for the person.
A suitable **ide-cel** product must be available for the person at a specific time before the study starts.
Women who can have children must have a negative pregnancy test and agree to use effective birth control methods or abstain from heterosexual contact during the study and for one year after treatment. Acceptable methods include certain hormonal contraceptives, intrauterine devices, or having a partner who has had a vasectomy. Women who are postmenopausal or have had certain surgeries may also participate.
Men must agree to abstain from sexual contact or use a condom during sexual contact with a pregnant woman or a woman who can have children for the duration of the study.

Who cannot join the trial?

10 criteria

Patients who have had a recent infection that is not fully resolved.
Patients with a history of severe allergic reactions to similar medications.
Patients who are currently pregnant or breastfeeding.
Patients with significant heart problems, such as uncontrolled high blood pressure or heart failure.
Patients with severe liver or kidney disease.
Patients who are taking medications that might interact negatively with the study drug.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of certain types of cancer that are not in remission.
Patients with a history of drug or alcohol abuse within the past year.
Patients who are unable to comply with the study procedures or follow-up visits.

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Verified sites

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Universitaetsklinikum Wuerzburg AöR
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Wuerzburg, Germany

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Investigated drugs

Dasatinib
is a medication being studied for its ability to prevent toxicity in patients undergoing treatment for relapsed or refractory multiple myeloma. In this trial, it is used to see if it can help reduce the side effects associated with the therapy.
Idecabtagene vicleucel
is a type of therapy used to treat multiple myeloma that has returned or is not responding to other treatments. It involves modifying the patient's own immune cells to better fight the cancer. The trial is investigating how well dasatinib can help manage the side effects of this therapy.

What is already known about the treatment

Dasatinib – Dasatinib is administered orally in tablet form and is currently being studied in clinical trials as a prophylactic treatment for cytokine release syndrome (CRS) associated with chimeric antigen receptor T cell therapy. It is primarily used in the treatment of certain types of leukemia, but in this trial, it is being evaluated for its safety and effectiveness in preventing CRS in patients with relapsed or refractory multiple myeloma. Dasatinib works by inhibiting specific proteins involved in the growth and survival of cancer cells, thereby reducing inflammation and immune response. It is classified as a tyrosine kinase inhibitor, which blocks the action of enzymes that promote cell division and survival.

Investigated diseases

Chimeric Antigen Receptor T Cell Therapy-Associated Cytokine Release Syndrome – This condition occurs as a side effect of a specific cancer treatment involving genetically modified T cells. It is characterized by an excessive immune response, leading to the release of a large number of cytokines into the bloodstream. Symptoms can include fever, fatigue, and muscle pain, and in more severe cases, it can affect multiple organs. The syndrome typically begins within a few days after the therapy is administered. The severity of symptoms can vary widely among individuals. Monitoring and managing the immune response is crucial to prevent complications.