NCT02971982

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Treatment

Interventions

Type	Name	Description
DRUG	rituximab /Dexamethasone/cyclophosphamide	rituximab:375mg/m2 ,Dexamethasone 20mg q12h,cyclophosphamide 750mg
DRUG	Velcade/Dexamethasone/cyclophosphamide	Velcade:1.3mg/m2,Dexamethasone 10mg q12h,cyclophosphamide 750mg

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-10-01
• Completion: 2018-12-01
• First posted: 2016-11-23
• Last updated: 2016-11-23

Locations

1 site across 1 country: China