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CDD Plus Bortezomib or CDDin Relapsed or Refractory Multiple Myeloma With Extramedullary Plasmacytoma

Primary Purpose

Extramedullary Plasmacytoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
CDD
CDD Plus Bortezomib
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extramedullary Plasmacytoma focused on measuring Bortezomib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female patients from 18 to 80
  • Biopsy-proven EMP with relapsed or refractory Myeloma disease. Patients may be proteasome inhibitor-exposed or naive, but cannot be refractory to proteasome inhibitor therapy
  • Disease requiring further treatment
  • Measurable disease such as M protein and Objective and measurable of EMP
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
  • Meet the clinical laboratories criteria as specified in the protocol
  • Voluntary written consent

Exclusion Criteria:

  • Female patients who are lactating, breastfeeding or pregnant
  • Evidence of current uncontrolled cardiovascular conditions as specified in study protocol
  • Requirement for other concomitant chemotherapy, immunotherapy, radiotherapy, which would be considered as a treatment of EMP.
  • Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Ongoing or active infection, known HIV positive, active hepatitis B or C infection
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Known allergy to any of the study medications

Sites / Locations

  • Yuping ZHONGRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CDD Plus Bortezomib

CDD

Arm Description

Patients will receive Bortezomib (1.3mg/m2) Subcutaneous injection on Days 1, 4,8,11 and plus dexamethasone 20 mg/day PO on Days 1-4, 9-12,Cyclophosphamide 300mg/m2 D1-4, Liposome doxorubicin 40mg D4 of each 28-day cycle; Patients may continue to receive treatment until PD or unacceptable toxicity.

Dexamethasone 20 mg/day PO on Days 1-4, 9-12,Cyclophosphamide 300mg/m2 D1-4, doxorubicin Dexamethasone 40mg D4 of each 28-day cycle; Patients may continue to receive treatment until PD or unacceptable toxicity

Outcomes

Primary Outcome Measures

Number of patients with overall hematologic response
Complete response, very good partial response and partial response

Secondary Outcome Measures

Number of patients with EMP response
response rate
Overall survival
The median overall survival
Time from diagnosis ofEMP to the date of death
Progression free survival
Time from date of diagnosis of EMP to the date of first documentation of disease
Number of adverse events
Adverse events, serious adverse events, assessment of clinical laboratory values from the date of signing of the informed consent form through 30 days after the last dose of study drug.

Full Information

First Posted
January 8, 2015
Last Updated
January 12, 2015
Sponsor
Beijing Chao Yang Hospital
Collaborators
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02336386
Brief Title
CDD Plus Bortezomib or CDDin Relapsed or Refractory Multiple Myeloma With Extramedullary Plasmacytoma
Official Title
Study of Cyclophosphamide，Liposome Doxorubicin Dexamethasone（CDD) Plus Bortezomib Compared With CDD in the Relapsed or Refractory Multiple Myeloma Combined With Extramedullary Plasmacytoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital
Collaborators
Peking University People's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether Cyclophosphamide, Liposome doxorubicin and Dexamethasone（CDD) Plus Bortezomib might have effective in extramedullary plasmacytoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extramedullary Plasmacytoma
Keywords
Bortezomib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CDD Plus Bortezomib
Arm Type
Experimental
Arm Description
Patients will receive Bortezomib (1.3mg/m2) Subcutaneous injection on Days 1, 4,8,11 and plus dexamethasone 20 mg/day PO on Days 1-4, 9-12,Cyclophosphamide 300mg/m2 D1-4, Liposome doxorubicin 40mg D4 of each 28-day cycle; Patients may continue to receive treatment until PD or unacceptable toxicity.
Arm Title
CDD
Arm Type
Active Comparator
Arm Description
Dexamethasone 20 mg/day PO on Days 1-4, 9-12,Cyclophosphamide 300mg/m2 D1-4, doxorubicin Dexamethasone 40mg D4 of each 28-day cycle; Patients may continue to receive treatment until PD or unacceptable toxicity
Intervention Type
Drug
Intervention Name(s)
CDD
Other Intervention Name(s)
Cyclophosphamide,Liposome doxorubicin and Dexamethasone
Intervention Description
Chemotherapy
Intervention Type
Drug
Intervention Name(s)
CDD Plus Bortezomib
Other Intervention Name(s)
Chemotherapy Plus Bortezomib
Intervention Description
Chemotherapy plus Proteasome Inhibitors
Primary Outcome Measure Information:
Title
Number of patients with overall hematologic response
Description
Complete response, very good partial response and partial response
Time Frame
Assessed every 2 cycles (median length of the endpoint assessment period is projected to be approximately 24 months)
Secondary Outcome Measure Information:
Title
Number of patients with EMP response
Description
response rate
Time Frame
Assessed every 2 cyeles period is projected to be approximately 24 months
Title
Overall survival
Description
The median overall survival
Time Frame
Monthly up to 3 years
Title
Time from diagnosis ofEMP to the date of death
Time Frame
Monthly up to 3 years
Title
Progression free survival
Time Frame
Monthly up to 2 years
Title
Time from date of diagnosis of EMP to the date of first documentation of disease
Time Frame
Monthly up to 2 years
Title
Number of adverse events
Description
Adverse events, serious adverse events, assessment of clinical laboratory values from the date of signing of the informed consent form through 30 days after the last dose of study drug.
Time Frame
Monthly up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients from 18 to 80 Biopsy-proven EMP with relapsed or refractory Myeloma disease. Patients may be proteasome inhibitor-exposed or naive, but cannot be refractory to proteasome inhibitor therapy Disease requiring further treatment Measurable disease such as M protein and Objective and measurable of EMP Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 Meet the clinical laboratories criteria as specified in the protocol Voluntary written consent Exclusion Criteria: Female patients who are lactating, breastfeeding or pregnant Evidence of current uncontrolled cardiovascular conditions as specified in study protocol Requirement for other concomitant chemotherapy, immunotherapy, radiotherapy, which would be considered as a treatment of EMP. Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens Ongoing or active infection, known HIV positive, active hepatitis B or C infection Psychiatric illness/social situations that would limit compliance with study requirements Known allergy to any of the study medications
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuping ZHONG, Doctor
Phone
861051718999
Email
zhongyp3352@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuping Zhong, Doctor
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yuping ZHONG
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100043
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuping ZHONG, Doctor
Phone
860105171-8999
Email
zhongyp3352@126.com
First Name & Middle Initial & Last Name & Degree
Yuping ZHONG, Doctor
First Name & Middle Initial & Last Name & Degree
Jin LU, Doctor

12. IPD Sharing Statement

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CDD Plus Bortezomib or CDDin Relapsed or Refractory Multiple Myeloma With Extramedullary Plasmacytoma

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