Study on Daratumumab with Bortezomib, Cyclophosphamide, and Dexamethasone for Multiple Myeloma Patients Not Eligible for Transplant
Prefer not to search? Our Concierge searches the trials for you.
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.
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.
Prefer not to search? Our Concierge searches the trials for you.
Tell us about your condition – we search every trial in Europe and connect you with the right site.
We usually reply within a few days
Trial locations
Where you can join this trial
Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.
Not recruitingNot sure what to do next?
Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.
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.
What is already known about the treatment
Investigated diseases
sourced from the EU Clinical Trials Register and site verification
Want to learn more about this trial or check if you can participate?