The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia

Study Overview
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Brief Summary
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The purpose of this study is to compare the efficacy of cyclophosphamide plus dexamethasone combined with rituximab or bortezomib regimens in newly diagnosed Waldenström macroglobulinemia patients.

Detailed Description
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Newly diagnosed WM patients will be randomly assigned to BCD or RCD group for introduction chemotherapy. Chemotherapeutic response will be evaluated after 3 cycles. If a PR or better response achieves, addition 3 cycles will be given. If not, patients will be crossed to control group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patients will quit this study.

Official Title
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The Efficacy of Cyclophosphamide Plus Dexamethasone Combinated With Rituximab or Bortezomib for the Newly Diagnosed Waldenström Macroglobulinemia - a Prospective Multicentre Randomized Control Trial From China

Conditions
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Waldenström Macroglobulinemia

Intervention / Treatment
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* Drug: Bortezomib
* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged >=18 years diagnosed with LPL/WM untreated or mild treated without standard regimens,especially untreated with rituximab and/or bortezomib symptom patients with life-expectancy more than 3 months. Exclusion Criteria: diagnosed with other malignancies outside B-NHL within one year(including active center neural system lymphoma) transformed lymphoma liver or renal function lesion unrelated to lymphoma serious complications such as uncontrolled diabetes,gastric ulcer or other serious angiocardiopathy determined by the physician HIV positive or active HBV infection or other uncontrolled systematic infection clinical central nervous dysfunction serious surgery within 30 days pregnancy or baby nursing period or un-contracepted child-bearing period woman; 9. allergy to the trail drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bortezomib<br>Patients in this group will receive bortezomib+ cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. Chemotherapeutic response will be evaluated after 3 cycles. If a PR or better response achieves, addition 3 cycles will be given. If not, patients will cross to RCD group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study. | Drug: Bortezomib<br>* compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia<br>* Other names: velcade;|
| Experimental: rituximab<br>Patients in this group will receive rituximab+cyclophosphamide+ dexamethasone as introduction chemotherapy regimen. Chemotherapeutic response will be evaluated after 3 cycles. If a PR or better response achieves, addition 3 cycles will be given. If not, patients will cross to BCD group for another 3 cycles. If a PR or better response comes out, addition 3 cycles will be given, otherwise, the patient will quit this study. | Drug: Rituximab<br>* compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia<br>* Other names: Mabthera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progress-free survival |  | up to 36 months |