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

Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02971982
• Other study ID #: myeloma-02
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 19, 2016
• Last updated: November 20, 2016
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: The First Affiliated Hospital of Soochow University
• Contact: Fu cheng cheng, PhD
• Phone: 86-512-67781856
• Email: evergirl[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Treatment
• Waldenstrom Macroglobulinemia

Intervention

Drug:
• rituximab /Dexamethasone/cyclophosphamide
rituximab:375mg/m2 ,Dexamethasone 20mg q12h,cyclophosphamide 750mg
• Velcade/Dexamethasone/cyclophosphamide
Velcade:1.3mg/m2,Dexamethasone 10mg q12h,cyclophosphamide 750mg

Locations

Country	Name	City	State
China	First Affiliated Hospital, Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigators try to compare the very good partial remission (VGPR) rate at the end of the research.		2 years	Yes
Primary	Investigators try to compare the complete remission (CR) rates at the end of the research.		2 years	Yes
Primary	Investigators try to compare Overall remission rate (MR+CR + VGPR + partial remission (PR) rate) at the end of the research.		2 years	Yes
Primary	Investigators try to compare major reaction rate (MRR, PR+VGPR+CR) at the end of the research.		2 yeas	Yes