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Study on Iberdomide for Maintenance Therapy in Patients with Newly Diagnosed Multiple Myeloma After Stem Cell Transplantation

Verified siteInvestigationalNo 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 disease called multiple myeloma, which is a type of cancer that affects the blood. The study is specifically for patients who have been newly diagnosed with this condition. The treatment being tested is a medication called iberdomide, which is taken in the form of a capsule. The purpose of the study is to evaluate how effective iberdomide is when used as a maintenance therapy after patients have undergone a procedure known as autologous stem cell transplantation. This procedure involves using a patient's own stem cells to help restore their bone marrow after intensive treatment.

Participants in the study will receive one of three different doses of iberdomide. The study will observe how well the treatment works in improving the patients' response to the disease over time. The trial will also include a group of patients who will receive a placebo, which is a substance with no active medication, to compare the effects. The study will last for a period of up to 48 months, during which patients will be monitored regularly to assess their response to the treatment and any side effects they may experience.

The trial aims to gather information on the safety and effectiveness of iberdomide in helping patients maintain their health after their initial treatment for multiple myeloma. By participating in this study, researchers hope to find out if iberdomide can help improve the quality of life and outcomes for patients with this condition. The results of this study could provide valuable insights into new treatment options for 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
Beginning of the trial
Upon joining the study, you will start the trial with a complete evaluation to confirm your eligibility. This includes a review of your medical history and current health status.
You will be informed about the trial procedures and asked to sign an informed consent form, which confirms your understanding and agreement to participate.
Step 2
Treatment initiation
You will begin taking the medication iberdomide in capsule form. The dosage will be determined by the study team and could be 0.45 mg, 0.75 mg, 1 mg, or 1.3 mg.
The medication is taken orally, and you will be instructed on the exact dosage and frequency. This will continue as part of your maintenance therapy after your stem cell transplantation.
Step 3
Regular monitoring
Throughout the trial, you will have regular check-ups to monitor your response to the treatment. This includes blood tests and other assessments to track your health and any changes in your condition.
You will be asked to report any side effects or changes in your health to the study team immediately.
Step 4
Response evaluation
Your response to the treatment will be evaluated at specific intervals. The study aims to see if your condition improves from partial response to very good partial response, complete response, or stringent complete response.
These evaluations will help determine the effectiveness of the treatment and guide any necessary adjustments.
Step 5
End of treatment
The treatment phase of the trial is expected to last up to six months, with evaluations continuing throughout this period.
After completing the treatment, you will have a final assessment to determine the overall impact of the therapy on your condition.
Step 6
Follow-up
After the treatment phase, you will enter a follow-up period where your health will continue to be monitored.
This follow-up is crucial to ensure your well-being and to gather long-term data on the treatment's effects.

Who can join the trial?

15 criteria

Must have been newly diagnosed with multiple myeloma, a type of blood cancer.
Need treatment because of specific symptoms or events related to the disease, and have measurable disease levels before starting initial therapy.
Must be within 15 months from diagnosis and 120 days after the last stem cell transplant or additional treatment, if done, and have shown at least a partial response to treatment.
Must be 18 years or older.
Must have a life expectancy of at least 3 months.
Must have a performance status of 0-1 on the ECOG scale, which measures daily living abilities.
Must have completed a full evaluation at diagnosis according to specific staging criteria.
Must have been treated with a combination of specific drugs and undergone a stem cell transplant.
Must be willing and able to follow the trial procedures.
Must understand and voluntarily sign an informed consent form before any study-related procedures.
Must have certain baseline blood values without recent transfusions to meet these levels.
Male participants must agree to use a condom during sexual contact with women who are pregnant or could become pregnant, and must not donate sperm during the study and for 90 days after the last dose.
All participants must agree not to donate blood during the study and for 28 days after the last dose.
All male and female participants must follow the requirements of the Pregnancy Prevention Program.
Females who can become pregnant must have two negative pregnancy tests before starting the study and agree to ongoing pregnancy testing. They must commit to abstinence or use two forms of contraception during the study and for 28 days after the last dose.

Who cannot join the trial?

5 criteria

Patients who have not been diagnosed with newly diagnosed multiple myeloma cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Patients who are not female or male subjects as specified cannot participate.
Patients who are not part of the vulnerable population selected for the study cannot participate.

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Verified sites

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

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Responsive
Rotterdam, The Netherlands

Trial locations

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Investigated drugs

Iberdomide is a medication being studied for its potential to help patients with multiple myeloma, a type of blood cancer. In this clinical trial, it is used as a maintenance treatment after patients have undergone a procedure called autologous stem cell transplantation. This procedure involves using the patient's own stem cells to help restore their bone marrow. The goal of using iberdomide in this trial is to see if it can improve the patients' response to treatment, helping them achieve better outcomes in terms of reducing cancer activity in their bodies.

Iberdomide

What is already known about the treatment

Iberdomide – Iberdomide is a medication administered orally, typically in the form of a pill. It is currently being studied in clinical trials for its effectiveness in treating newly diagnosed multiple myeloma, a type of blood cancer. The main therapeutic use of Iberdomide is to maintain and improve the response to treatment after a patient has undergone an autologous stem cell transplant. At the molecular level, Iberdomide works by modulating the immune system and targeting specific proteins that help cancer cells grow, thereby slowing down or stopping their proliferation. It is classified as an immunomodulatory drug, which means it helps regulate the immune system to fight cancer.

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 a single plasma cell becomes abnormal and starts to multiply uncontrollably, leading to an accumulation of abnormal cells in the bone marrow. These abnormal cells can produce a large amount of a single type of antibody, which can cause damage to the bones and interfere with the production of normal blood cells. As the disease progresses, it can lead to bone pain, fractures, anemia, kidney dysfunction, and increased susceptibility to infections. The disease often progresses in stages, with periods of stability followed by periods of active disease. Over time, the accumulation of abnormal plasma cells can lead to significant health issues, affecting various organs and systems in the body.