Not recruiting

Study on Iberdomide and Dexamethasone, Alone or with Drug Combination, for Newly Diagnosed Multiple Myeloma Patients Not Eligible for Transplant

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 disease called Multiple Myeloma, which is a type of cancer that affects the blood. The study is testing a new treatment approach for patients who have been newly diagnosed with this disease and are not eligible for a transplant. The treatment involves using a medication called Iberdomide, which is taken as a capsule, either alone or in combination with other treatments. In one part of the study, Iberdomide is combined with a medication called Dexamethasone, and in another part, it is combined with both Daratumumab and Dexamethasone. The purpose of the study is to see how effective these treatment combinations are in helping patients respond to the treatment.

The study will follow participants over a period of time to observe their response to the treatment. Participants will receive the treatment and be monitored for any changes in their condition. The study aims to measure how well the treatment works by looking at the overall response rate, which means how many patients show improvement, and the complete response rate, which means how many patients have no signs of the disease after treatment. The study will also look at other factors, such as how long patients live without the disease getting worse and their overall survival.

Throughout the study, participants will undergo various assessments to track their health and the effects of the treatment. These assessments may include tests to check for minimal residual disease, which is a small number of cancer cells that might remain after treatment, and questionnaires to evaluate the quality of life. The study will also collect information on any side effects experienced by participants and any changes in their health status. The goal is to gather comprehensive data to understand the potential benefits and risks of the treatment for patients with 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
Enrollment
Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis of multiple myeloma, and ability to comply with study requirements.
Informed consent is obtained, ensuring understanding of the study procedures and the ability to withdraw at any time.
Step 2
Initial assessment
Initial assessments are conducted to establish baseline health status. This includes measuring disease markers and overall health indicators.
Step 3
Treatment phase 1: iberdomide and dexamethasone
The first treatment phase involves taking iberdomide orally in combination with dexamethasone. The dosage and frequency are determined by the study protocol.
Regular monitoring is conducted to assess response to treatment and manage any side effects.
Step 4
Treatment phase 2: combination therapy
In the second phase, treatment may include a combination of iberdomide, daratumumab (administered via IV infusion), and dexamethasone.
The goal is to evaluate the effectiveness of this combination in improving response rates.
Step 5
Ongoing assessments
Throughout the study, regular assessments are conducted to monitor disease progression, treatment response, and overall health.
These assessments include blood tests, imaging, and questionnaires to evaluate quality of life.
Step 6
Completion and follow-up
Upon completion of the treatment phases, follow-up assessments are conducted to evaluate long-term outcomes and any lasting effects of the treatment.
The study is estimated to conclude by December 2029, with ongoing monitoring as needed.

Who can join the trial?

12 criteria

The patient must be willing and able to follow the study requirements, according to the investigator's opinion.
For female patients who can have children, they must use effective birth control methods as per local regulations. They should not be pregnant or breastfeeding and must understand the risks to an unborn child. They need to start using birth control 28 days before the study, during the study, and for at least 3 months after the last dose. They must also agree to regular pregnancy tests and inform the study doctor if there is any risk of pregnancy.
For male patients, they must use a condom during sexual activity with a pregnant female or a female who can have children, even if they have had a vasectomy. They should understand the risks of donating sperm and discuss family planning options with the study doctor.
Any side effects from previous treatments must be mild (Grade 1 or less) at the time of joining the study, except for hair loss.
The patient must be able to understand the study procedures.
The patient must provide written consent to participate in the study, knowing they can withdraw at any time without affecting their future medical care.
The patient must have been newly diagnosed with **Multiple Myeloma**, be 65 years or younger, and not eligible for a transplant. They should need active treatment as per guidelines.
The patient must have a measurable disease, which means certain levels of specific proteins in the blood or urine.
The patient must be classified as non-frail or frail using a specific scale, with 30% of patients being frail.
The patient must have a performance status of 2 or less on a scale that measures daily living abilities.
The patient must be 18 years or older.
The patient must have adequate organ function as defined in the study protocol.

Who cannot join the trial?

10 criteria

Patients who have had a recent heart attack or severe heart problems.
Patients with uncontrolled high blood pressure.
Patients with active infections that require treatment.
Patients who are pregnant or breastfeeding.
Patients with a history of other cancers, unless they have been cancer-free for a certain period.
Patients with severe liver or kidney disease.
Patients who have received certain treatments for multiple myeloma recently.
Patients with known allergies to the study drugs.
Patients who are unable to follow the study procedures.
Patients with certain blood disorders.

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Verified sites

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

Hestia Duran I Reynals
Verified
L'hospitalet De Llobregat, Spain
Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital Universitario 12 De Octubre
Verified
Madrid, Spain

Trial locations

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Investigated drugs

Iberdomide
is a medication being studied for its effectiveness in treating patients who have been newly diagnosed with multiple myeloma and are not eligible for a transplant. It is being tested both on its own and in combination with other treatments to see how well it works in helping patients respond to therapy.
Dexamethasone
is a type of steroid medication that is used to reduce inflammation and suppress the immune system. In this trial, it is used in combination with iberdomide to help enhance the treatment's effectiveness against multiple myeloma.
Daratumumab
is a medication that targets specific proteins on the surface of cancer cells. It is used in combination with iberdomide and dexamethasone in this trial to see if it can improve the response rate in patients with multiple myeloma who are not eligible for a transplant.

What is already known about the treatment

Iberdomide
Iberdomide is administered orally and is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, particularly in patients who are not eligible for transplants. It is often used in combination with dexamethasone, and sometimes with daratumumab, to enhance its therapeutic effects. The medication works by modulating the immune system and targeting specific proteins involved in the growth and survival of cancer cells. Iberdomide is classified as an immunomodulatory drug, and its development is focused on improving response rates in multiple myeloma treatment.
Dexamethasone
Dexamethasone is an oral medication widely used in various medical conditions, including multiple myeloma, due to its anti-inflammatory and immunosuppressant properties. It is often combined with other drugs like iberdomide and daratumumab in clinical trials to assess its efficacy in enhancing treatment outcomes. Dexamethasone works by suppressing the immune response and reducing inflammation, which can help control the progression of cancer. It is classified as a corticosteroid and is a well-established component of multiple myeloma treatment regimens.
Daratumumab
Daratumumab is administered intravenously and is an approved treatment for multiple myeloma, often used in combination with other medications like dexamethasone and iberdomide in clinical trials. It targets a specific protein on the surface of myeloma cells, leading to their destruction by the immune system. Daratumumab is classified as a monoclonal antibody and has shown effectiveness in improving response rates in patients with multiple myeloma. Its use is focused on enhancing the overall treatment efficacy in combination therapies.

Investigated diseases

Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. These cancerous plasma cells multiply rapidly, leading to an overproduction of abnormal proteins that can cause damage to bones, kidneys, and the immune system. As the disease progresses, it can result in bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of these abnormal cells can also lead to the formation of tumors in the bones or soft tissues. Over time, the disease can cause significant complications, including kidney dysfunction and severe bone damage. The progression of Multiple Myeloma is typically characterized by periods of remission and relapse.