Not recruitingRare disease

Study on Carfilzomib and Ibrutinib for Patients with Waldenström’s Macroglobulinemia

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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 the effectiveness and safety of a treatment for Waldenström’s Macroglobulinemia, a rare type of blood cancer. The study is comparing two treatments: one group will receive a combination of two medications, Carfilzomib and Ibrutinib, while the other group will receive Ibrutinib alone. Carfilzomib is given as a solution through a vein, and Ibrutinib is taken as a capsule by mouth.

The purpose of the study is to explore how well the combination of Carfilzomib and Ibrutinib works compared to Ibrutinib alone in patients who are either newly diagnosed or have had a return of the disease after previous treatment. Participants will be randomly assigned to one of the two treatment groups. The study will monitor the participants over a period to see how their disease responds to the treatment and to check for any side effects.

Throughout the study, researchers will look at various outcomes, such as how long it takes for the disease to respond to treatment, how long the response lasts, and the overall survival of the participants. The study will also assess the quality of life of the participants during the treatment period. This trial aims to provide valuable information on the potential benefits of adding Carfilzomib to the treatment plan for patients with Waldenström’s Macroglobulinemia.

The research process

The trial runs in 7 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 asked to sign an informed consent form. This form confirms that you understand the purpose and procedures of the study and agree to participate.
You will need to meet certain health criteria, such as having a confirmed diagnosis of Waldenström’s Macroglobulinemia and being at least 18 years old.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your health status. This may include a physical examination, blood tests, and imaging studies.
Your heart function will be assessed to ensure it meets the required standards for participation.
Step 3
Randomization
You will be randomly assigned to one of two groups: one group will receive Carfilzomib in combination with Ibrutinib, and the other group will receive Ibrutinib alone.
This process ensures that the study results are unbiased and scientifically valid.
Step 4
Treatment phase
If you are in the combination group, you will receive Carfilzomib through intravenous administration. The dosage and frequency will be determined by the study protocol.
You will also take Ibrutinib orally in the form of hard capsules. The dosage and frequency will be specified by the study protocol.
If you are in the Ibrutinib alone group, you will take the medication orally as specified.
Step 5
Regular monitoring
Throughout the study, you will have regular check-ups to monitor your health and the effects of the treatment.
These check-ups may include physical exams, blood tests, and other assessments as needed.
Step 6
End of treatment
The treatment phase will last for a specified duration, after which your response to the treatment will be evaluated.
You will undergo a final assessment to determine the outcome of the treatment and any side effects experienced.
Step 7
Follow-up
After the treatment phase, you will continue to be monitored for a period to assess long-term effects and overall health.
This may involve periodic visits and assessments as outlined in the study protocol.

Who can join the trial?

10 criteria

Must have a confirmed diagnosis of Waldenström’s Macroglobulinemia (WM), a type of blood cancer.
Must sign a form to show they understand the study and agree to participate.
Can be newly diagnosed or have WM that has returned or not responded to treatment, regardless of genetic type.
Must meet at least one specific medical condition to start the study treatment.
Must have a performance status of 2 or less, which means they can do all self-care but are unable to carry out any work activities.
Must have a left ventricular ejection fraction of 40% or more, which is a measure of how well the heart pumps blood.
Must be 18 years or older and expected to live more than 3 months according to the study doctor.
Must have acceptable laboratory test results.
Women of childbearing potential must agree to use a highly effective birth control method during the study and for 6 months after the last dose of study medication.
Men must agree not to father a child during the study and for 6 months after, and must advise their female partners to use a highly effective birth control method. Men must also refrain from donating sperm during this time.

Who cannot join the trial?

9 criteria

Patients who have a different type of cancer other than Waldenström’s Macroglobulinemia.
Patients who have had previous treatment with the study drugs Carfilzomib or Ibrutinib.
Patients who have serious heart problems.
Patients with uncontrolled high blood pressure.
Patients who have an active infection that needs treatment.
Patients who are pregnant or breastfeeding.
Patients who have a history of severe allergic reactions to similar drugs.
Patients who have a condition that affects their ability to understand or follow the study instructions.
Patients who are participating in another clinical trial at the same time.

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Verified sites

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

Verified
Alexandra Hospital
Athens, Greece
Verified
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Ulm, Germany
Verified
Kath. St. Paulus GmbH
Dortmund, Germany

Trial locations

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Investigated drugs

Carfilzomib
is a medication used in this clinical trial to treat a type of blood cancer called Waldenström’s Macroglobulinemia. It works by blocking the action of certain proteins in cancer cells, which can help to stop the growth and spread of these cells. In this trial, Carfilzomib is being tested in combination with another medication to see if it is more effective than using the other medication alone.
Ibrutinib
is another medication used in this trial. It is designed to treat Waldenström’s Macroglobulinemia by targeting specific proteins in the cancer cells, which can help to slow down or stop their growth. Ibrutinib is already used to treat this type of cancer, and the trial is investigating whether adding Carfilzomib to the treatment can improve outcomes for patients.

What is already known about the treatment

Carfilzomib
Carfilzomib is administered as an injection into a vein, typically given by a healthcare professional. It is currently being studied in combination with Ibrutinib for its effectiveness in treating Waldenström’s Macroglobulinemia, a type of blood cancer. Carfilzomib works by blocking the action of proteasomes, which are structures inside cells that break down proteins, leading to cancer cell death. It is classified as a proteasome inhibitor.
Ibrutinib
Ibrutinib is taken orally in the form of a capsule or tablet. It is an established treatment for Waldenström’s Macroglobulinemia and is being evaluated for its effectiveness when used alone or in combination with Carfilzomib. Ibrutinib works by blocking a specific protein called Bruton's tyrosine kinase (BTK), which helps cancer cells grow and survive. It is classified as a BTK inhibitor.

Investigated diseases

Waldenström’s Macroglobulinemia – Waldenström’s Macroglobulinemia is a rare type of non-Hodgkin lymphoma characterized by an overproduction of abnormal white blood cells called lymphoplasmacytic cells. These cells produce large amounts of a protein known as monoclonal immunoglobulin M (IgM) antibody, which can thicken the blood and cause various symptoms. The disease progresses slowly, often beginning with symptoms like fatigue, weight loss, and night sweats. As it advances, patients may experience more severe symptoms such as vision problems, neuropathy, and bleeding issues due to the increased blood viscosity. Over time, the accumulation of these abnormal cells in the bone marrow can lead to anemia and other blood-related complications. The progression of the disease varies among individuals, with some experiencing stable periods and others facing more rapid changes.