PCD Versus RCD for the Treatment of Patients With Waldenstrom's Macroglobulinemia

Study Overview
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Brief Summary
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Patients will receive RCD or PCD combination as induction treatment followed by rituximab or velcade maintenance therapy, as the investigators try to compare the, very good partial remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR + partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the research.

Detailed Description
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This is an open-label, single-centre, randomised study, looking at a series of 40 patients up to the age of 75 with newly diagnosed Waldenstrom's macroglobulinemia (WM) not previously treated. Patients will receive RCD or PCD combination as induction treatment followed by rituximab or velcade maintenance therapy, as the investigators try to compare the, very good partial remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR + partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the research.

Official Title
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Velcade/Dexamethasone/Cyclophosphamide(PCD) Versus Rituximab /Dexamethasone/Cyclophosphamide(RCD) for the Treatment of Patients With Waldenstrom's Macroglobulinemia

Conditions
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Treatment

Intervention / Treatment
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* Drug: rituximab /Dexamethasone/cyclophosphamide
* Drug: Velcade/Dexamethasone/cyclophosphamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recently diagnosed WM according to the second 2002 WM international working group Not previously treated, apart from not regularly received by Chlorambucil Aged from 18 to 75 years, both male and female Ability to give signed informed consent Negative pregnancy test at inclusion (if necessary) ECOG from 0 to 2 Exclusion Criteria: Known hypersensitivity to rituximab or velcade or cyclophosphamide Uncontrolled infection including bacteria, virus and fungus, including active HBV infection Organic dysfunction: Bilirubin > 1.5 x normal above, Renal failure requiring dialysis, glutamic pyruvic transaminase (ALT) and Glutamic-Oxaloacetic Aminotransferase (AST) > 2.5 x normal above Positive HIV serology Serious psychiatric item in the history

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: rituximab /Dex/CTX<br>rituximab /Dexamethasone/cyclophosphamide 6 cycles followed by rituximab (at least 2 cycles) rituximab:375mg/m2 d1 Dexamethasone:40mg d1-4 cyclophosphamide:750mg/m2,d1-28 | Drug: rituximab /Dexamethasone/cyclophosphamide<br>* rituximab:375mg/m2 ,Dexamethasone 20mg q12h,cyclophosphamide 750mg<br>|
| Experimental: Velcade/Dex/CTX<br>Velcade/Dexamethasone/cyclophosphamide 6 cycles followed by velcade (at least 2 cycles) Velcade:1.3mg/m2 d1,d4,d8,d11 Dexamethasone:20mg d1-2,d4-5,d8-9,d11-12 cyclophosphamide:750mg/m2,d1-28 | Drug: Velcade/Dexamethasone/cyclophosphamide<br>* Velcade:1.3mg/m2,Dexamethasone 10mg q12h,cyclophosphamide 750mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigators try to compare the very good partial remission (VGPR) rate at the end of the research. |  | 2 years | 
| Investigators try to compare the complete remission (CR) rates at the end of the research. |  | 2 years | 
| Investigators try to compare Overall remission rate (MR+CR + VGPR + partial remission (PR) rate) at the end of the research. |  | 2 years | 
| Investigators try to compare major reaction rate (MRR, PR+VGPR+CR) at the end of the research. |  | 2 yeas |