Not recruiting

Study on Daratumumab with Bortezomib, Cyclophosphamide, and Dexamethasone for 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 Multiple Myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The treatment being tested is called Daratumumab, which is given as a solution for injection. This study aims to explore the safety and effectiveness of adding Daratumumab to a standard treatment regimen that includes three other medications: Bortezomib, Cyclophosphamide, and Dexamethasone. These medications are commonly used to treat multiple myeloma and work together to help control the disease.

The purpose of the study is to see how well this combination of treatments works for patients who are not eligible for a bone marrow transplant. The study will follow patients who receive this treatment to see how they respond over time. If the disease returns, patients may receive Daratumumab again to see if it helps manage the cancer at that stage. The study will monitor patients' health and response to the treatment over several months to gather important information about its effectiveness and safety.

Participants in the study will receive the treatment through injections and will be closely monitored by healthcare professionals. The study will look at various outcomes, such as how long patients remain free from disease progression and their overall survival. This research is important for understanding how well Daratumumab works in combination with other treatments for multiple myeloma, especially for those who cannot undergo a transplant.

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
Initial visit
Upon joining the clinical trial, the first step involves an initial visit to the study site. During this visit, a healthcare professional will review the signed written informed consent and confirm eligibility based on specific criteria, such as age, diagnosis of multiple myeloma, and other health conditions.
Women of childbearing potential will undergo a pregnancy test to ensure eligibility. This test must show a negative result before starting the treatment.
Step 2
Treatment initiation
The treatment begins with the administration of daratumumab, which is provided as a solution for injection. This medication is given through a subcutaneous injection, meaning it is injected under the skin.
In addition to daratumumab, the treatment includes a combination of other medications: bortezomib, cyclophosphamide, and dexamethasone. These medications are part of the standard induction regimen known as VCd.
Step 3
Treatment cycles
The treatment is organized into cycles. Each cycle involves receiving the medications at specified intervals. The primary goal is to assess the response after 8 cycles of the combination treatment, referred to as DVCd.
During these cycles, regular monitoring and assessments will be conducted to evaluate the effectiveness and safety of the treatment.
Step 4
Maintenance therapy
After completing the initial treatment cycles, maintenance therapy may be initiated. This involves continued administration of daratumumab, along with other medications as needed, to maintain the response achieved during the initial treatment.
The effectiveness of the maintenance therapy will be assessed through various tests, including checking for minimal residual disease (MRD) negativity.
Step 5
Follow-up and monitoring
Throughout the trial, regular follow-up visits will be scheduled to monitor health status, treatment response, and any side effects experienced.
These visits are crucial for ensuring the safety and well-being of participants and for collecting data on the long-term effects of the treatment.
Step 6
End of trial
The trial is expected to continue until December 31, 2030. Participants will be informed about the completion of the trial and any further steps or treatments that may be necessary.
Final assessments will be conducted to evaluate overall survival, progression-free survival, and other outcomes related to the treatment.

Who can join the trial?

10 criteria

Signed written informed consent is required. This means you agree to participate in the study and understand what it involves.
Men who are sexually active with women who can become pregnant must use a reliable birth control method with a failure rate of less than 1% per year. They must continue using this method for 6 months after finishing the treatment.
Patients must have a diagnosis of multiple myeloma that has not been treated before, according to specific medical guidelines.
ECOG ≤2 is required. This is a scale used to assess how well you can perform daily activities. A score of 2 or less means you are able to carry out light work or are up and about more than half of the day.
Patients must not be eligible or willing to undergo autologous transplantation, which is a procedure where a patient's own stem cells are used to replace damaged or diseased bone marrow.
Participants must be aged 18 years or older.
Women of childbearing potential must use an appropriate method of birth control and agree to continue using it for 6 months after the last dose of the study medication.
Women of childbearing potential must have a negative pregnancy test within one to two weeks before starting the study medication.
Women are not considered to be of childbearing potential if they are post-menopausal or have had certain surgeries that prevent pregnancy, such as removal of ovaries, fallopian tubes, or uterus.
Women must not be breastfeeding during the study.

Who cannot join the trial?

14 criteria

Patients with any other serious medical condition that might interfere with the study.
Patients who have had another type of cancer in the past, unless it was treated and has not come back for at least 5 years.
Patients who are pregnant or breastfeeding.
Patients who have an active infection that requires treatment.
Patients who have had a heart attack or stroke in the past 6 months.
Patients who have severe heart disease.
Patients who have severe lung disease.
Patients who have severe liver disease.
Patients who have severe kidney disease.
Patients who have a known allergy to any of the study drugs.
Patients who are currently participating in another clinical trial.
Patients who have received certain treatments for multiple myeloma in the past.
Patients who have a history of drug or alcohol abuse.
Patients who have a mental health condition that might interfere with the study.

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Verified sites

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

Johanniter GmbH Johanniter-Krankenhaus
Verified
Bonn, Germany
Klinikum der Universitaet Muenchen AöR
Verified
Munich, Germany
Universitaetsklinikum Tuebingen AöR
Verified
Tuebingen, Germany

Trial locations

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Investigated drugs

Daratumumab
is a medication used in this clinical trial to treat patients with myeloma, a type of blood cancer. It works by helping the immune system to find and destroy cancer cells. In this trial, daratumumab is given to patients who cannot undergo a transplant as their first treatment. It is also used again if the cancer comes back after the initial treatment.
Bortezomib
is another medication used in this trial. It helps to stop the growth of cancer cells by interfering with their ability to divide and multiply. Bortezomib is part of the standard treatment regimen for myeloma and is used in combination with other medications to improve its effectiveness.
Cyclophosphamide
is a medication that helps to kill cancer cells by damaging their DNA, which prevents them from growing and dividing. It is used in this trial as part of the standard treatment regimen for myeloma, working alongside other medications to enhance the overall treatment effect.
Dexamethasone
is a type of steroid used in this trial to help reduce inflammation and suppress the immune system. It is often used in combination with other cancer treatments to help manage side effects and improve the effectiveness of the treatment regimen for myeloma.

Daratumumab

What is already known about the treatment

Daratumumab – Daratumumab is administered as an injection, typically given into a vein. It is currently being studied for its effectiveness and safety in treating multiple myeloma, particularly for patients who are not eligible for a transplant. The main therapeutic use of daratumumab is to treat multiple myeloma, a type of blood cancer. At the molecular level, daratumumab works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. It is classified as a monoclonal antibody, a type of medication designed to target specific proteins in the body.

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. In this disease, cancerous plasma cells multiply and accumulate in the bone marrow, leading to bone damage and affecting the production of normal blood cells. As the disease progresses, it can cause bone pain, fractures, and anemia due to the reduced production of healthy blood cells. Patients may also experience kidney problems and increased susceptibility to infections. Over time, the accumulation of abnormal plasma cells can lead to the formation of tumors in bones and other tissues. The disease is characterized by periods of remission and relapse, with symptoms varying in severity.