CompletedPhase 3

Efficacy of First Line DRC +/- Bortezomib for Patients With Waldenström's Macroglobulinemia

Germany202 participantsStarted 2013-11

Plain-language summary

In Waldenström macroglobulinemia (WM) conventional chemotherapy induces only low CR rates and responses of short duration compared to other indolent lymphomas. Thus innovative approaches are needed which combine excellent activity and tolerability in patients with WM, who are mostly of advanced age. The immunochemotherapy DRC (dexamethasone, rituximab, cyclophosphamide) was shown to be highly effective in patients with WM without inducing major hematological toxicities. On the other hand the proteasome inhibitor Bortezomib showed substantial activity as a single agent in WM with only very few side effects when given in a weekly schedule. Based on these observations it is the aim of this study to test whether the efficacy of the well tolerated DRC regime can be further improved by adding Bortezomib.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Clinicopathological diagnosis of WM as defined by consensus panel one of the Second International Workshop on WM. Pathological diagnosis has to occur before study inclusion and randomization. In addition, pathological specimens have to be sent to the national pathological reference center at study inclusion and randomization. The positivity for CD20 can be assumed from any previous bone marrow immunohistochemistry or flow cytometry analysis performed up to 6 months prior to enrollment. Inclusion in the study will be based on morphological and immunological criteria. Immunophenotyping will be performed in each center and saved locally. Flow cytometry of bone marrow and blood cells will include at least one double staining and assess the expression of the following antigens: surface immunoglobulin, CD19, CD20, CD5, CD10 and CD23. Patients are eligible if tumor cells express the following antigens: CD19, CD20, and if they are negative for CD5, CD10 and CD23 expression. Patients with tumor cells positive for CD5 and/or CD23 and morphologically similar to WM cells may be included after ruling out other low grade B-cell malignancies. * Presence of at least one criterion for initiation of therapy, according to the 2nd Workshop on WM: * Recurrent fever, night sweats, weight loss, fatigue * Hyperviscosity * Lymphadenopathy which is either symptomatic or bulky (≥5 cm in maximum diameter) * Symptomatic hepatomegaly and/or splenomegaly * Symptomatic organ…

What they're measuring

Progression Free Survival

Timeframe: participants will be followed for their participation in the trial, an expected average of 5.5 years

Trial details

NCT IDNCT01788020

SponsorUniversity of Ulm

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-11