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Study on the Effectiveness of Ixazomib, Lenalidomide, and Dexamethasone in Treating Newly Diagnosed Multiple Myeloma in Patients Eligible for Transplant

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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 multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. The study will use a combination of medications, including ixazomib, lenalidomide, and dexamethasone. These medications are taken in the form of capsules. The purpose of the study is to assess the effectiveness of this treatment combination in reducing the amount of cancer cells remaining in the body after treatment, known as minimal residual disease.

Participants in the study will receive the treatment over a period of several months. The treatment plan includes an initial phase called induction, followed by a procedure known as autologous stem cell transplant (ASCT), and then further treatment phases called consolidation and maintenance. The study will monitor the safety and effectiveness of the treatment through regular blood tests and bone marrow analyses. The goal is to determine how well the treatment works in eliminating cancer cells and to ensure it is safe for patients.

Throughout the study, participants will be closely monitored by healthcare professionals to track their response to the treatment and any side effects they may experience. The study aims to provide valuable information on the potential benefits of this treatment combination for patients with newly diagnosed multiple myeloma who are eligible for a transplant. The study is expected to continue until 2028, allowing researchers to gather comprehensive data on the long-term effects and outcomes of the treatment.

The research process

The trial runs in 5 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 required to provide written informed consent. This is a document that confirms your voluntary participation and understanding of the study procedures. You can withdraw your consent at any time without affecting your future medical care.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes a review of your medical history, a physical examination, and laboratory tests to ensure you meet the study criteria.
Step 3
Treatment phase
The treatment phase involves taking a combination of medications: ixazomib, lenalidomide, and dexamethasone. These medications are taken orally in the form of capsules.
Ixazomib is administered as NINLARO 4 mg hard capsules. Lenalidomide is available in various dosages: Revlimid 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg hard capsules. The specific dosage and frequency will be determined by the study protocol and your healthcare provider.
The duration of the treatment phase will be specified in the study protocol, and you will be monitored regularly to assess the effectiveness and safety of the treatment.
Step 4
Monitoring and follow-up
Throughout the study, regular monitoring will be conducted. This includes blood tests and bone marrow analyses to assess the response to treatment and check for any minimal residual disease.
Follow-up visits will be scheduled to ensure your safety and to evaluate the treatment's impact on your condition.
Step 5
End of study
At the end of the study, a final assessment will be conducted. This will include a comprehensive evaluation of your health status and the overall outcomes of the treatment.
You will receive information about the results of the study and any further steps or recommendations for your ongoing care.

Who can join the trial?

15 criteria

Patients must be newly diagnosed with multiple myeloma and eligible for a transplant.
Patients should be between 18 and 70 years old.
Patients must not have received any prior treatment for multiple myeloma, except for a specific dose of a steroid called dexamethasone or similar steroids, and local radiotherapy for symptom control.
Patients must have a symptomatic and measurable disease, diagnosed by standard criteria.
Patients must provide voluntary written informed consent before any study-related procedures.
Female patients must either be postmenopausal for at least 1 year, surgically sterile, or agree to use two effective methods of contraception if they are of childbearing potential. They must also agree to ongoing pregnancy testing and follow the guidelines of the lenalidomide pregnancy prevention program.
Male patients must agree to use effective barrier contraception or practice true abstinence and follow the guidelines of the lenalidomide pregnancy prevention program.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, which indicates their level of functioning.
Patients must meet specific laboratory criteria, including:
- An absolute neutrophil count (ANC) of at least 1,000/mm³.
- A platelet count of at least 75,000/mm³.
- Total bilirubin levels no more than 1.5 times the upper limit of normal.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels no more than 3 times the upper limit of normal.
- A calculated creatinine clearance of at least 30 mL/min, which measures kidney function.
- Patients must be willing and able to follow the study protocol and visit schedule.
- If applicable, patients must have a negative pregnancy test at the time of inclusion in the study.

Who cannot join the trial?

10 criteria

Patients with any other active cancer cannot participate.
Patients who have had a heart attack or severe heart problems in the past 6 months are not eligible.
Patients with uncontrolled high blood pressure cannot join the study.
Patients with severe liver disease are excluded.
Patients with severe kidney disease are not allowed to participate.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients with active infections that require treatment are not eligible.
Patients who have received another investigational drug within the last 30 days cannot participate.
Patients with known allergies to the study drugs are excluded.
Patients with a history of drug or alcohol abuse in the past year are not eligible.

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Verified sites

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

Helse Stavanger HF
Verified
Stavanger, Norway
Helsinki University Central Hospital
Verified
Helsinki, Finland
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Responsive
Vilnius, Lithuania

Trial locations

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Investigated drugs

Ixazomib
is a medication used in this clinical trial to help treat certain types of blood cancer. It works by blocking the action of certain proteins in cancer cells, which can slow down or stop the growth of these cells. This medication is taken by mouth and is part of a combination treatment to improve its effectiveness.
Lenalidomide
is another medication used in the trial. It helps the immune system fight cancer by affecting the way the immune system works. It can also stop the growth of cancer cells and reduce the blood supply to tumors. This medication is also taken by mouth and is used in combination with other treatments to enhance its effects.
Dexamethasone
is a type of steroid used in this study. It helps reduce inflammation and can also help kill cancer cells or make them more sensitive to other cancer treatments. Dexamethasone is taken by mouth and is used alongside other medications to improve the overall treatment outcome.

What is already known about the treatment

Ixazomib
Ixazomib is a medication administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, a type of blood cancer. The main therapeutic use of ixazomib is to help control the growth of cancer cells in patients with multiple myeloma. At the molecular level, ixazomib works by inhibiting a protein complex called the proteasome, which is responsible for breaking down proteins in cells, leading to cancer cell death. It is classified as a proteasome inhibitor in pharmacology.
Lenalidomide
Lenalidomide is taken orally as a capsule and is widely used in the treatment of multiple myeloma. It is well-documented in medical literature for its role in managing this condition. The primary therapeutic indication for lenalidomide is to slow down or stop the growth of cancer cells in multiple myeloma patients. It works by modulating the immune system and inhibiting the growth of blood vessels that supply the cancer cells. Lenalidomide is classified as an immunomodulatory drug.
Dexamethasone
Dexamethasone is an oral medication available in tablet form and is commonly used in combination with other drugs to treat multiple myeloma. It is a well-established medication in medical practice and literature. The main therapeutic use of dexamethasone is to reduce inflammation and suppress the immune response, which can help control cancer symptoms and enhance the effectiveness of other cancer treatments. It acts by mimicking the effects of cortisol, a natural hormone, and is classified as a corticosteroid.

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. The disease 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, causing symptoms such as anemia, increased risk of infections, and bone damage. As the disease progresses, it can lead to bone pain, fractures, and high levels of calcium in the blood. The abnormal cells can also produce a protein that can damage the kidneys. Over time, the disease can cause significant complications related to bone health and blood cell production.