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

NCT02971982 | Unknown Phase 1

• 1 other identifier: myeloma-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Treatment

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

rituximab /Dex/CTX

EXPERIMENTAL

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

Velcade/Dex/CTX

EXPERIMENTAL

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

Interventions

rituximab /Dexamethasone/cyclophosphamide DRUG

rituximab:375mg/m2 ,Dexamethasone 20mg q12h,cyclophosphamide 750mg

rituximab /Dex/CTX

Velcade/Dexamethasone/cyclophosphamide DRUG

Velcade:1.3mg/m2,Dexamethasone 10mg q12h,cyclophosphamide 750mg

Velcade/Dex/CTX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ECOG from 0 to 2

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

First Affiliated Hospital, Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Interventions

Rituximab; Dexamethasone; Cyclophosphamide; Bortezomib

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Fu cheng cheng, Phd

  First Affiliated Hospital,Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fu cheng cheng, PhD

CONTACT

86-512-67781856; evergirl@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: November 23, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 23, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)