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Study on the Safety and Effectiveness of Anitocabtagene Autoleucel and Drug Combination for Patients with Newly Diagnosed Multiple Myeloma

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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 specifically for individuals who have been newly diagnosed with this condition. The main treatment being investigated is a medication called anitocabtagene autoleucel, also known by its code name KITE-772. This is a type of cell therapy where a patient's own T cells, a kind of immune cell, are modified to better fight the cancer. Other medications involved in the study include bortezomib, lenalidomide, dexamethasone, isatuximab, daratumumab, tocilizumab, cyclophosphamide, and fludarabine.

The purpose of the study is to evaluate how safe and effective anitocabtagene autoleucel is for treating newly diagnosed multiple myeloma. Participants will receive this treatment after undergoing initial therapy, known as induction therapy, which helps to reduce the cancer cells before the main treatment. The study will monitor participants over time to see how well the treatment works and to check for any side effects. The study is designed to gather information on how the treatment affects the cancer and the overall health of the participants.

Participants in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will take place over several months, with regular check-ups to monitor the participants' health and the progress of the treatment. The goal is to understand the benefits and any potential risks associated with the treatment, providing valuable information for future use in treating multiple myeloma.

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 a review of medical history and a series of tests to ensure all criteria are met.
Step 2
Induction therapy
The induction therapy phase begins with the administration of medications to prepare the body for the main treatment. This may include a combination of bortezomib (subcutaneous), lenalidomide (oral), dexamethasone (oral), and either isatuximab (intravenous) or daratumumab (subcutaneous).
The specific dosage and frequency of these medications are determined by the healthcare provider based on individual needs and responses.
Step 3
Anitocabtagene autoleucel infusion
Following induction therapy, the main treatment involves the infusion of anitocabtagene autoleucel (intravenous infusion). This is a specialized treatment designed to target and treat multiple myeloma cells.
Step 4
Supportive care
During the treatment, supportive care may be provided to manage any side effects. This can include medications like tocilizumab (intravenous) to manage inflammation and fludarabine (intravenous) or cyclophosphamide (intravenous) to support the immune system.
Step 5
Monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment and manage any adverse effects. This includes blood tests, imaging studies, and other evaluations as needed.
Follow-up visits are scheduled to ensure the treatment is effective and to make any necessary adjustments.
Step 6
Long-term safety follow-up
Participants are asked to consent to a long-term safety follow-up, which may last up to 15 years. This is to monitor the long-term effects of the treatment and ensure ongoing safety.

Who can join the trial?

19 criteria

Must have been newly diagnosed with Multiple Myeloma according to specific medical guidelines.
For one group, patients must be 70 years old or younger. For other groups, patients must be 80 years old or younger.
Must have a measurable level of disease at the start of the study, which can be determined by specific blood or urine tests.
Must be eligible to receive specific treatment regimens, as decided by the study doctor.
Must be 18 years or older and able to give informed consent, meaning you understand and agree to participate in the study.
Must have a performance status of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
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Must have adequate blood health, including:
- Hemoglobin level of at least 7.5 g/dL without recent blood transfusions.
- Neutrophil count of at least 500/µL without recent growth factor support.
- Platelet count of at least 75,000/µL, unless affected by the disease, in which case 50,000/µL is acceptable.
- Lymphocyte count of at least 100/µL.
- Normal blood clotting tests unless on stable medication for blood clots.
- check
  Must have adequate kidney, liver, lung, and heart function, including:
  - Kidney function with an estimated filtration rate of at least 45 mL/min.
  - Liver enzymes (ALT and AST) within 3 times the normal limit.
  - Total bilirubin level within 1.5 mg/dL, with exceptions for certain conditions.
  - Heart function with an ejection fraction of at least 45% and no significant fluid around the heart.
  - No significant fluid in the lungs or abdomen.
  - Oxygen levels in the blood above 92% on room air.
  - Females who can have children must have a negative pregnancy test and use effective birth control.
  - Must be willing to follow study procedures and participate in long-term follow-up for up to 15 years.

Who cannot join the trial?

3 criteria

Patients who have not been diagnosed with newly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) criteria cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who belong to a vulnerable population cannot participate.

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Verified sites

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

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Hospital Clinic De Barcelona
Barcelona, Spain
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Hospital Universitario 12 De Octubre
Madrid, Spain
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Hospital Universitario De Navarra
Pamplona, Spain

Trial locations

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Investigated drugs

Anitocabtagene autoleucel is a type of treatment known as CAR-T cell therapy. This therapy involves taking some of your own immune cells, called T cells, and changing them in a lab so they can better recognize and attack cancer cells. After these cells are modified, they are put back into your body to help fight the cancer. In this trial, the focus is on using this therapy for people who have been newly diagnosed with multiple myeloma, a type of blood cancer. The goal is to see how safe and effective this treatment is after you have received initial therapy for your cancer.

Tocilizumab

What is already known about the treatment

Anitocabtagene autoleucel – This medication is administered through an infusion, which means it is given directly into the bloodstream. It is currently being studied in clinical trials for its safety and effectiveness in treating newly diagnosed multiple myeloma, a type of blood cancer. The main purpose of this medication is to help the immune system recognize and attack cancer cells. It works by modifying the patient's own immune cells to better target and destroy the cancer. Anitocabtagene autoleucel is classified as a type of gene therapy, specifically a CAR-T cell therapy, which is a cutting-edge approach in cancer treatment.

Investigated diseases

Multiple Myeloma – Multiple myeloma is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. It begins when abnormal plasma cells multiply uncontrollably, leading to an accumulation in the bone marrow. This accumulation can interfere with the production of normal blood cells and cause damage to bones. As the disease progresses, it can lead to symptoms such as bone pain, fatigue, and increased susceptibility to infections. The disease can also cause high levels of calcium in the blood, kidney problems, and anemia. Over time, multiple myeloma can lead to significant complications affecting various organs and systems in the body.