Not recruitingRare disease

Study Comparing Anitocabtagene Autoleucel with Standard Treatment for Patients with Relapsed or Refractory 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 known as relapsed/refractory multiple myeloma, which is a type of blood cancer that has returned or is not responding to treatment. The study aims to compare the effectiveness and safety of a new treatment called anitocabtagene autoleucel against standard treatments that are currently used for this condition. Anitocabtagene autoleucel is a type of cell therapy, which involves using a patient's own modified cells to fight the cancer. The standard treatments being compared include medications such as pomalidomide, dexamethasone, carfilzomib (also known as PR-171), bortezomib, and daratumumab.

The purpose of the study is to see how well anitocabtagene autoleucel works in helping patients live longer without their disease getting worse. Participants in the study will be randomly assigned to receive either the new treatment or one of the standard treatments. The study will monitor the participants over time to assess their response to the treatment, including how long they remain free from disease progression and their overall survival. The study will also look at the side effects of the treatments and how they affect the participants' quality of life.

This trial is designed to provide valuable information about the potential benefits and risks of anitocabtagene autoleucel compared to existing therapies for relapsed/refractory multiple myeloma. The study will continue until enough data is collected to make a meaningful comparison between the treatments. The results of this study could help improve treatment options for patients with this challenging condition.

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
Joining the study
Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the new treatment called anitocabtagene autoleucel, and the other group will receive standard care therapy. This assignment is random, like flipping a coin, and neither you nor the study team can choose which group you will be in.
Step 2
Treatment phase
If you are in the group receiving anitocabtagene autoleucel, you will receive this treatment through an intravenous infusion, which means it will be given directly into your vein. The exact schedule and number of infusions will be explained to you by the study team.
If you are in the standard care therapy group, you may receive one of several possible treatments. These include medications such as pomalidomide (Imnovid) taken orally in capsule form, dexamethasone (Neofordex) taken orally in tablet form, carfilzomib (Kyprolis) given as an infusion, bortezomib (Bortezomib Fresenius Kabi) given as an injection, and daratumumab (DARZALEX) given as an infusion. The specific treatment, dosage, and schedule will be determined by the study team based on your individual needs.
Step 3
Monitoring and follow-up
Throughout the study, your health will be closely monitored. This includes regular visits to the study site for check-ups, blood tests, and other assessments to see how you are responding to the treatment.
You will be asked to report any side effects or changes in your health to the study team. This information is important to ensure your safety and to understand the effects of the treatment.
Step 4
End of study participation
Your participation in the study will continue until the study ends or until you and the study team decide it is best for you to stop. The study is expected to end by October 31, 2030.
After your participation ends, you may be asked to attend a final follow-up visit to assess your health and gather any remaining information needed for the study.

Who can join the trial?

8 criteria

Must have a documented historical diagnosis of multiple myeloma (MM).
Must have received 1 to 3 previous treatments for MM, including an immunomodulatory drug (IMiD) and an anti-CD38 monoclonal antibody (mAb). You must have had at least 2 consecutive cycles of each drug in any previous treatment. These drugs do not need to be from the same treatment plan.
Must have documented evidence of progressive disease (worsening of the disease) based on specific criteria, determined by the investigator, within 12 months of the last dose of the last treatment.
Must have measurable disease at screening, defined as one of the following: a) Serum M-protein level of at least 0.5 g/dL or urine M-protein level of at least 200 mg/24 hours; or b) Light chain MM without measurable disease in the serum or urine: serum free light chain of at least 10 mg/dL and an abnormal serum free light chain ratio.
Must be a candidate to receive at least one of the four standard of care therapy (SOCT) regimens (PVd, DPd, KDd, or Kd), as determined by the investigator.
Must be male or female aged 18 years or older and have provided written informed consent.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means you are fully active or have some symptoms but do not require bed rest during the day.
Females of childbearing potential must have a medically supervised negative pregnancy test. Females who have had surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of childbearing potential.

Who cannot join the trial?

3 criteria

Patients who have not been diagnosed with relapsed/refractory multiple myeloma cannot participate. This means the disease has returned or is not responding to treatment.
Patients who have not received 1 to 3 previous treatments for their condition are excluded.
Patients who have not been treated with both an immunomodulatory drug and an anti-CD38 monoclonal antibody cannot join. An immunomodulatory drug helps regulate or normalize the immune system, and an anti-CD38 monoclonal antibody is a type of treatment that targets specific proteins on cancer cells.

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Verified sites

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Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

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Investigated drugs

Anitocabtagene Autoleucel is a type of therapy that uses your own immune cells to fight cancer. In this treatment, some of your immune cells are taken from your blood and changed in a lab to help them recognize and attack cancer cells. After they are changed, these cells are put back into your body to help fight the multiple myeloma, which is a type of blood cancer. This therapy is being tested to see if it works better than the usual treatments for people whose cancer has come back or hasn't responded to other treatments.

What is already known about the treatment

Anitocabtagene Autoleucel – This medication is administered through a process called CAR T-cell therapy, where a patient's own T-cells are modified in a lab to better recognize and attack cancer cells, and then infused back into the patient. It is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory multiple myeloma, a type of blood cancer, in patients who have already tried other treatments. The main goal of this therapy is to improve progression-free survival, meaning the length of time during and after treatment that a patient lives with the disease without it getting worse. Anitocabtagene autoleucel works by targeting specific proteins on the surface of cancer cells, helping the immune system to identify and destroy them. It is classified as a type of immunotherapy, which is a treatment that uses the body's own immune system to fight cancer.

Investigated diseases

Relapsed/Refractory Multiple Myeloma – This is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. In relapsed multiple myeloma, the disease returns after a period of improvement. Refractory multiple myeloma refers to the condition not responding to treatment or progressing despite therapy. The disease is characterized by the accumulation of abnormal plasma cells in the bone marrow, leading to bone damage, anemia, kidney dysfunction, and increased risk of infections. As the disease progresses, patients may experience bone pain, fatigue, and frequent infections. The progression of the disease can vary, with periods of stability followed by periods of active disease.