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

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ClinicalTrials.gov Identifier: NCT02971982
Recruitment Status : Unknown
Verified October 2016 by The First Affiliated Hospital of Soochow University.
Recruitment status was:  Recruiting
First Posted : November 23, 2016
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Soochow University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Treatment Drug: rituximab /Dexamethasone/cyclophosphamide Drug: Velcade/Dexamethasone/cyclophosphamide Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Velcade/Dexamethasone/Cyclophosphamide(PCD) Versus Rituximab /Dexamethasone/Cyclophosphamide(RCD) for the Treatment of Patients With Waldenstrom's Macroglobulinemia
Study Start Date : October 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: rituximab /Dex/CTX
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
rituximab:375mg/m2 ,Dexamethasone 20mg q12h,cyclophosphamide 750mg
Experimental: Velcade/Dex/CTX
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
Velcade:1.3mg/m2,Dexamethasone 10mg q12h,cyclophosphamide 750mg


Outcome Measures
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Primary Outcome Measures :
  1. Investigators try to compare the very good partial remission (VGPR) rate at the end of the research. [ Time Frame: 2 years ]
  2. Investigators try to compare the complete remission (CR) rates at the end of the research. [ Time Frame: 2 years ]
  3. Investigators try to compare Overall remission rate (MR+CR + VGPR + partial remission (PR) rate) at the end of the research. [ Time Frame: 2 years ]
  4. Investigators try to compare major reaction rate (MRR, PR+VGPR+CR) at the end of the research. [ Time Frame: 2 yeas ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971982


Contacts
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Contact: Fu cheng cheng, PhD 86-512-67781856 evergirl@sina.com

Locations
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China, Jiangsu
First Affiliated Hospital, Soochow University Recruiting
Suzhou, Jiangsu, China, 215000
Contact: Fu chengcheng, Phd    13962191404    evergirl@sina.com   
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
Investigators
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Principal Investigator: Fu cheng cheng, Phd First Affiliated Hospital,Soochow University
More Information
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Responsible Party: The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT02971982    
Other Study ID Numbers: myeloma-02
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Dexamethasone
Dexamethasone acetate
Cyclophosphamide
Rituximab
Bortezomib
BB 1101
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists