Efficacy of First Line B-RI for Treatment Naive Waldenström's Macroglobulinemia
This study focuses on Waldenström's Macroglobulinemia (WM), a blood cancer where current chemotherapy options often don't lead to long-lasting results. For older patients especially, gentler but still effective treatments are needed. This research is testing a new approach that avoids traditional chemotherapy. It combines three existing medications: Ibrutinib, Bortezomib, and Rituximab (called B-RI). Researchers want to find out if this combination can effectively treat WM in people who haven't had treatment before, while also leading to fewer side effects compared to older methods. The goal is to improve how well people respond to treatment and reduce the difficult side effects often associated with chemotherapy in this condition.
At a glance
What is this study about?
This study is for people who have been diagnosed with Waldenström's Macroglobulinemia (WM) but haven't started any treatment yet. WM is a rare type of blood cancer that affects certain white blood cells. While current treatments, often involving chemotherapy, can help, they sometimes don't lead to long-lasting improvements, and the side effects can be tough, especially for older patients.
The main idea behind this study is to see if a combination of three different medicines can treat WM effectively without needing traditional chemotherapy. The medicines are Ibrutinib, Bortezomib, and Rituximab. Ibrutinib is a newer drug that has shown good results, and Rituximab and Bortezomib are also used to treat blood cancers. Researchers think putting these three together might be a powerful way to fight WM with fewer of the difficult side effects commonly linked to chemotherapy.
This study is trying to find out if this new chemotherapy-free combination is as good as, or even better than, existing treatments. It's hoped that this approach will not only be effective in managing the cancer but also improve the patient's quality of life by reducing the side effects they experience.
Key takeaways
- Tests a new chemotherapy-free treatment for WM.
- Aims to be effective with fewer side effects than traditional chemotherapy.
- For newly diagnosed patients with active WM.
- Combines three specific drugs: Ibrutinib, Bortezomib, and Rituximab.
- Participation involves regular clinic visits and monitoring.
Who may be eligible?
To join this study, you must have a confirmed diagnosis of Waldenström's Macroglobulinemia (WM) from a specialist and you must not have started any treatment for it yet. The doctors will check your diagnosis very carefully to make sure it's WM and not another similar condition.
You also need to be experiencing symptoms from your WM that mean treatment is necessary. These could include things like unexplained fevers, night sweats, weight loss, feeling very tired, thick blood (hyperviscosity), enlarged lymph nodes, liver, or spleen, nerve problems, or specific blood issues like low red blood cells or platelets due to your WM.
Essentially, the study is looking for people who are newly diagnosed with WM and whose condition is active enough that they would normally begin treatment. Your doctor will carefully review all your medical information to see if you meet these specific requirements.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Have you been diagnosed with Waldenström's Macroglobulinemia?
- Have you NOT received any treatment for your WM yet?
- Are you currently experiencing symptoms from your WM that require treatment?
- Are you 18 years old or older?
- Has a specialist doctor confirmed your WM diagnosis?
What does participation involve?
This study is a Phase 2 trial, which means it's one of the earlier stages of testing a new treatment combination. If you join, you will receive the combination of Ibrutinib, Bortezomib, and Rituximab. Ibrutinib is a tablet you take by mouth, and Bortezomib and Rituximab are given as injections, either under the skin or into a vein. The exact schedule of these treatments will be explained in detail by the study team.
You will have regular visits to the clinic for assessments. These will involve physical examinations, blood tests, and possibly other tests like bone marrow biopsies to see how you are responding to the treatment and to check for any side effects. The study aims to evaluate both how well the treatment works and how well it is tolerated.
The total duration of your participation, including treatment and follow-up, will be clearly outlined by the study team. They will monitor your health and the progress of your WM very closely throughout this period.
Potential risks and benefits
Locations (12)
- Studiengesellschaft Onkologie Bielefeld GbRVerified postcodeBielefeld, Germany
- DIAKO Ev. Diakonie-Krankenhaus gGmbH, Med. Klinik IIVerified postcodeBremen, Germany
- Universitätsklinikum Halle, Klinik für Innere Medizin IVVerified postcodeHalle, Germany
- Universtätsmedizin Mannheim, III. Medizinische Klinik Studienzentrale im MCCVerified postcodeMannheim, Germany
- Kliniken Maria Hilf GmbH (Krankenhaus St. Franziskus), Medizinische Klinik I (Klinik f. Hämatologie, Onkologie, Gastroentereologie)Verified postcodeMönchengladbach, Germany
- Kliniken Ostalb Stauferklinikum Schwäbisch Gmünd, Zentrum für Innere MedizinVerified postcodeMutlangen, Germany
- Hämato-Onkologische Gemeinschaftspraxis Pasing-FürstenfeldbruckVerified postcodeMünchen, Germany
- Klinikum der Universität München, Medizinische Klinik und Poliklinik IIIVerified postcodeMünchen, Germany
- Universitätsklinikum Münster, Med. Klinik AVerified postcodeMünster, Germany
- Universitätsklinikum Ulm; Klinik für Innere Medizin Innere Medizin IIIVerified postcodeUlm, Germany
- Gemeinschaftspraxis Dres. Rudolf Schlag, Björn Schöttker, Joachim HaasVerified postcodeWürzburg, Germany
- 'Alexandra' General Hospital of AthensVerified postcodeAthens, Greece
Common questions
What is Waldenström's Macroglobulinemia (WM)?
It's a rare type of cancer that affects certain white blood cells in your body.
What does 'treatment naive' mean?
It means you haven't received any treatment for your WM yet.
Are the study drugs chemotherapy?
No, this study is testing a combination of three non-chemotherapy drugs: Ibrutinib, Bortezomib, and Rituximab.
What is a Phase 2 study?
It means this is an early stage of research to see if a new treatment is effective and safe before it's compared to existing treatments in larger studies.
Will I have to pay to be in the study?
No, all study-related treatments and tests will be provided free of charge.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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