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Study Comparing Continuous and Fixed Duration Therapy with Daratumumab, Lenalidomide, and Dexamethasone for Patients with Relapsed 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 type of blood cancer called multiple myeloma, which affects the plasma cells in the bone marrow. The study is investigating the effectiveness of a combination of medications: Daratumumab, Lenalidomide, and Dexamethasone. Daratumumab, also known by its code name HuMax-CD38, is a protein-based treatment given through an injection. Lenalidomide is taken orally, and Dexamethasone can be administered both orally and intravenously. The purpose of the study is to compare two different treatment approaches: continuous therapy versus a fixed duration of therapy for patients whose multiple myeloma has returned after initial treatment.

Participants in the study will receive one of the two treatment plans. The continuous therapy group will receive the medications until the disease progresses, while the fixed duration group will receive the medications for a set period of 24 months. The study aims to determine if the fixed duration treatment is as effective as the continuous treatment in terms of overall survival over four years. Throughout the study, participants will be monitored regularly to assess their response to the treatment and any side effects they may experience.

The trial will also evaluate the quality of life of participants using questionnaires and analyze the cost-effectiveness of the treatments. The study is designed to provide valuable information on the best treatment approach for relapsed multiple myeloma, helping to improve patient care and outcomes in the future.

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 randomly assigned to one of two groups. One group will receive treatment for a fixed duration of 24 months, while the other group will continue treatment until the disease progresses.
Step 2
Treatment initiation
The treatment involves a combination of three medications: daratumumab, lenalidomide, and dexamethasone.
Daratumumab will be administered as a subcutaneous injection. The frequency and dosage will be determined by the study protocol.
Lenalidomide will be taken orally. The dosage and frequency will be specified by the study team.
Dexamethasone will be administered either orally or intravenously, depending on the specific requirements of the study.
Step 3
Ongoing treatment
Throughout the study, you will receive regular treatments as per the assigned group. The study team will monitor your health and response to the treatment.
You will be required to attend scheduled visits for assessments and to receive your medications.
Step 4
Monitoring and assessments
Your health and the effectiveness of the treatment will be regularly assessed. This includes physical examinations, blood tests, and other necessary evaluations.
Quality of life will be evaluated every 12 weeks using specific questionnaires.
Step 5
End of treatment
If you are in the fixed duration group, your treatment will conclude after 24 months. If you are in the continuous treatment group, your treatment will continue until the disease progresses.
After the treatment ends, follow-up assessments will be conducted to monitor your health and any long-term effects of the treatment.

Who can join the trial?

10 criteria

Must be an adult (18 years or older).
Must use an effective method of contraception during treatment and for 3 months after the last dose if you are a woman of childbearing age or a man with a partner of childbearing age. This includes methods like birth control pills, implants, IUDs, or complete abstinence (no sexual intercourse).
Must have documented multiple myeloma (MM) that has come back after treatment and needs a new round of therapy.
Must have measurable disease, which means certain levels of specific proteins in the blood or urine that doctors can track.
Must have received one prior line of therapy for MM.
Must have shown a response (partial response or better) to the previous treatment.
Must have an ECOG Performance Status score of 0, 1, or 2, which is a scale that measures how well you can perform daily activities. A score of 0 means fully active, 1 means some symptoms but nearly fully active, and 2 means unable to work but can do all self-care activities.
If you have any side effects from previous treatments, they must be resolved or stable.
Must provide signed informed consent, which means you agree to participate after being informed about the study.
Must be affiliated with a social security system or equivalent.

Who cannot join the trial?

11 criteria

Patients with other types of cancer that are not related to blood or bone marrow.
Patients who have had a different type of cancer in the past, unless it was treated and has not come back for at least 5 years.
Patients with serious heart problems, such as heart failure or a recent heart attack.
Patients with severe lung disease that makes it hard to breathe.
Patients with severe liver disease, which affects how the liver works.
Patients with severe kidney disease, which affects how the kidneys work.
Patients who are pregnant or breastfeeding.
Patients who have an active infection that needs treatment.
Patients who have a history of allergic reactions to the study drugs.
Patients who are currently participating in another clinical trial.
Patients who have a mental health condition that makes it hard to understand or follow the study instructions.

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Verified sites

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

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Verified
CHU Grenoble Alpes
La Tronche, France

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Investigated drugs

Daratumumab
is a medication used in the treatment of multiple myeloma, a type of blood cancer. It works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. In this trial, Daratumumab is being tested to see if it can help control the disease when given continuously or for a fixed period.
Lenalidomide
is a drug that helps the immune system fight cancer and also stops the growth of cancer cells. It is often used in combination with other medications to treat multiple myeloma. In this study, Lenalidomide is part of a combination therapy being evaluated for its effectiveness in treating patients whose cancer has returned after initial treatment.
Dexamethasone
is a type of steroid that reduces inflammation and helps control the immune system. It is used in cancer treatment to help reduce side effects and enhance the effectiveness of other cancer medications. In this clinical trial, Dexamethasone is used alongside other drugs to treat relapsed multiple myeloma.

What is already known about the treatment

Daratumumab
Daratumumab is administered as an injection, typically given into a vein. It is currently well-regarded in medical literature for its role in treating multiple myeloma, a type of blood cancer. The main use of Daratumumab is to help manage this cancer, especially when it has returned after treatment. It works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. Daratumumab is classified as a monoclonal antibody, a type of medication that specifically targets certain proteins in the body.
Lenalidomide
Lenalidomide is taken orally in the form of a capsule. It is widely used in the medical field for treating multiple myeloma and other blood disorders. The primary purpose of Lenalidomide is to slow down or stop the growth of cancer cells and to boost the immune system's ability to fight cancer. It works by affecting the immune system and the growth of cancer cells, making it harder for them to survive. Lenalidomide is classified as an immunomodulatory drug, which means it modifies the immune system's response to help fight cancer.
Dexamethasone
Dexamethasone is usually taken orally in tablet form, but it can also be given as an injection. It is a well-established medication in the treatment of multiple myeloma and other inflammatory conditions. The main therapeutic use of Dexamethasone is to reduce inflammation and suppress the immune system, which can help manage symptoms and improve the effectiveness of other cancer treatments. It works by mimicking the effects of hormones produced by the adrenal glands, reducing inflammation and immune responses. Dexamethasone is classified as a corticosteroid, a type of steroid hormone.

Investigated diseases

Multiple Myeloma – Multiple Myeloma is a type of cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. The disease begins when abnormal plasma cells multiply uncontrollably, leading to the production of a large amount of abnormal proteins. As the disease progresses, it can cause damage to bones, kidneys, and the immune system. Patients may experience symptoms such as bone pain, frequent infections, and fatigue. Over time, the accumulation of abnormal cells can lead to anemia and increased risk of fractures. The progression of the disease is often marked by periods of remission and relapse.