Not recruitingRare disease

Study on the Effectiveness of Bortezomib, Rituximab, and Ibrutinib for Patients with Newly Diagnosed 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 of a treatment combination for patients with a specific type of blood cancer called Waldenström’s Macroglobulinemia. The treatment being tested includes three medications: Bortezomib, Rituximab, and Ibrutinib. These medications are used together to see how well they work in patients who have not received any previous treatment for this condition.

The purpose of the study is to evaluate how effective this combination is in preventing the progression of the disease over a one-year period. Participants in the study will receive the treatment and be monitored for changes in their condition. The study will track how long it takes for the disease to respond to the treatment and how long the response lasts. The safety of the treatment and any side effects will also be closely observed.

Participants will receive Bortezomib as a solution for injection, Rituximab either as an infusion or injection, and Ibrutinib in capsule form. The study will follow a specific schedule for administering these medications and will include regular check-ups to assess the participants' health and the treatment's impact on their condition. The study aims to provide valuable information on the potential benefits of this treatment combination for patients with Waldenström’s Macroglobulinemia.

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
Initial visit
Upon joining the study, an initial visit is scheduled. During this visit, a comprehensive medical evaluation is conducted to confirm eligibility. This includes a review of medical history, a physical examination, and laboratory tests.
The purpose of these tests is to ensure that the patient meets the study's inclusion criteria and to establish baseline health data.
Step 2
Treatment initiation
The treatment phase begins with the administration of the study medications. The patient receives ibrutinib in the form of IMBRUVICA 140 mg hard capsules, taken orally once daily.
Additionally, rituximab is administered as a 500 mg concentrate for solution for infusion and a 1400 mg solution for subcutaneous injection. The infusion is given in a healthcare setting, while the subcutaneous injection is administered under the skin.
The patient also receives bortezomib as a 3.5 mg powder for solution for injection, which is injected under the skin.
Step 3
Treatment schedule
The treatment is structured in cycles. Each cycle lasts for a specified period, during which the medications are administered according to the study protocol.
The frequency and duration of each medication are determined by the study team and are based on the patient's response and tolerance to the treatment.
Step 4
Regular monitoring
Throughout the study, regular monitoring visits are scheduled. These visits include physical examinations, laboratory tests, and assessments of the patient's response to the treatment.
The purpose of these visits is to ensure the patient's safety and to evaluate the effectiveness of the treatment.
Step 5
End of treatment
At the end of the treatment phase, a final evaluation is conducted. This includes a comprehensive assessment of the patient's health and a review of the study's outcomes.
The patient may be asked to return for follow-up visits to monitor long-term effects and overall health status.

Who can join the trial?

11 criteria

Must have a confirmed diagnosis of Waldenström’s Macroglobulinemia (WM), a type of blood cancer, as defined by specific medical guidelines.
Men must agree not to father a child during the treatment and for 12 months after, using a condom, and advise their female partner to use a highly effective birth control method.
Must provide voluntary written consent to participate in the study, understanding that they can withdraw at any time without affecting future medical care.
Must have at least one of the following symptoms to start treatment: recurrent fever, night sweats, weight loss, fatigue, thickened blood (hyperviscosity), enlarged lymph nodes, enlarged liver or spleen, organ or tissue involvement, nerve damage due to WM, certain blood disorders, kidney problems related to WM, or low blood counts.
Must have a World Health Organization (WHO)/ECOG performance status of 0 to 2, which measures the ability to perform daily activities.
Must be 18 years or older.
Must have a life expectancy of more than 3 months.
Must have a baseline platelet count of at least 100 x 10⁹/L, unless low due to the disease, without needing transfusions.
Must have an absolute neutrophil count of at least 1 x 10⁹/L without needing growth factor support.
Must meet specific laboratory test criteria before starting the study, including liver function tests (ASAT/SGOT and ALAT/SGPT), bilirubin levels, and kidney function tests (serum creatinine or estimated Glomerular Filtration Rate).
Women of childbearing potential must agree to use a highly effective birth control method during treatment and for a specified time after, depending on the medication, and add a barrier method if using hormonal birth control.

Who cannot join the trial?

3 criteria

Patients who have already received treatment for Waldenström’s Macroglobulinemia cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

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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
Klinikum der Universitaet Muenchen AöR
Munich, Germany

Trial locations

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Investigated drugs

Bortezomib
is a medication used in the treatment of certain types of cancer, including Waldenström’s Macroglobulinemia. It works by interfering with the growth of cancer cells, ultimately leading to their death. This helps to slow down or stop the progression of the disease.
Rituximab
is a type of therapy known as a monoclonal antibody. It targets specific proteins on the surface of cancer cells, marking them for destruction by the body's immune system. This helps to reduce the number of cancer cells and control the disease.
Ibrutinib
is a medication that blocks certain enzymes that promote the growth of cancer cells. By inhibiting these enzymes, Ibrutinib helps to prevent the cancer cells from multiplying and spreading, which can help manage the disease and improve patient outcomes.

What is already known about the treatment

Bortezomib
Bortezomib is administered as an injection, typically given under the skin or into a vein. It is currently used in clinical trials for treating Waldenström’s Macroglobulinemia, a type of cancer. The medication works by interfering with the growth of cancer cells, ultimately leading to their death. Bortezomib is classified as a proteasome inhibitor, which means it blocks the action of proteasomes, cellular complexes that break down proteins.
Rituximab
Rituximab is given as an intravenous infusion, meaning it is administered directly into the bloodstream through a vein. It is being studied for its effectiveness in treating Waldenström’s Macroglobulinemia. Rituximab targets specific proteins on the surface of certain immune cells, leading to their destruction. It is classified as a monoclonal antibody, which is a type of protein designed to bind to specific targets in the body.
Ibrutinib
Ibrutinib is taken orally in the form of a capsule. It is part of ongoing research for treating Waldenström’s Macroglobulinemia. The drug works by blocking a protein called Bruton's tyrosine kinase, which is involved in the growth and survival of cancer cells. Ibrutinib is classified as a kinase inhibitor, a type of medication that interferes with specific enzymes involved in cell signaling.

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), which can thicken the blood and lead to various symptoms. The disease progresses slowly, often beginning with symptoms such as fatigue, weight loss, and night sweats. As it advances, patients may experience more severe symptoms like vision problems, bleeding, and neurological issues due to the increased blood viscosity. Over time, the accumulation of these abnormal cells can also lead to enlarged lymph nodes, spleen, and liver. The progression of the disease varies among individuals, with some experiencing stable periods and others facing more rapid changes.