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Spots Global Cancer Trial Database for R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's Macroglobulinemia

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Trial Identification

Brief Title: R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom's Macroglobulinemia

Official Title: A Multicenter Prospective Phase II Study of Rituximab Combined, Lenalidomide, Dexamethasone Followed by Lenalidomide Maintenance in Patients With Newly Diagnosed Waldenström's Macroglobulinemia

Study ID: NCT03697356

Study Description

Brief Summary: A multicenter prospective phase II study of rituximab combined, lenalidomide, dexamethasone followed by lenalidomide maintenance in patients with newly diagnosed Waldenström's macroglobulinemia (Ballondor trial)

Detailed Description: Most patients with Waldenstrom's Macroglobulinemia are rare, and most studies are based on Phase II clinical studies, so the most effective regimen has not been established. However, in patients without experience of treatment with rituximab monotherapy targeting CD20 antigen expressed on lymphocytic cells, the response rate is reported to be approximately 25% -45%. Combined chemotherapy including rituximab is recommended as a primary treatment. In Korea, there are few studies on Waldenstrom's Macroglobulinemia, and a relatively large number of patients have studied the data of 71 patients in 2014, retrospectively. In the present study, we found that the combined chemotherapy regimen with rituximab significantly improved the overall response rates. Bortezomib may also be effective in the treatment of Waldenstrom's Macroglobulinemia. Based on this, clinical trials of combined chemotherapy with rituximab or dexamethasone have been conducted and 80-90% reported However, lenalidomide 15mg alone was administered, lenalidomide was effective in Waldenstrom's Macroglobulinemia with a 29% overall response rate. The authors concluded that the combination therapy of rituximab, bortezomib, lenalidomide, and dexamethasone is an effective treatment regimen that can improve the overall response rate including complete remission. Patients with Waldenstrom's Macroglobulinemia diagnosed in Korea we planned this study to evaluate the efficacy and safety of lenalidomide maintenance therapy with chemotherapy with chemotherapy including rituximab, bortezomib, lenalidomide, and dexamethasone

Keywords

Eligibility

Minimum Age: 19 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Kosin University Gospel Hospital, Busan, Sue-gu, Korea, Republic of

Contact Details

Name: HoSup Lee

Affiliation: KUGH

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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