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

January 12, 2015 updated by: Yuping Zhong, Beijing Chao Yang Hospital

Study of Cyclophosphamide，Liposome Doxorubicin Dexamethasone（CDD) Plus Bortezomib Compared With CDD in the Relapsed or Refractory Multiple Myeloma Combined With Extramedullary Plasmacytoma Patients

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100043
        • Recruiting
        • Yuping ZHONG
        • Contact:
        • Principal Investigator:
          • Yuping ZHONG, Doctor
        • Principal Investigator:
          • Jin LU, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CDD Plus Bortezomib
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.
Drug: CDD Plus Bortezomib
Chemotherapy plus Proteasome Inhibitors
Other Names:
  • Chemotherapy Plus Bortezomib
Active Comparator: CDD
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
Drug: CDD
Chemotherapy
Other Names:
  • Cyclophosphamide,Liposome doxorubicin and Dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with overall hematologic response
Time Frame: Assessed every 2 cycles (median length of the endpoint assessment period is projected to be approximately 24 months)
Complete response, very good partial response and partial response
Assessed every 2 cycles (median length of the endpoint assessment period is projected to be approximately 24 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with EMP response
Time Frame: Assessed every 2 cyeles period is projected to be approximately 24 months
response rate
Assessed every 2 cyeles period is projected to be approximately 24 months
Overall survival
Time Frame: Monthly up to 3 years
The median overall survival
Monthly up to 3 years
Time from diagnosis ofEMP to the date of death
Time Frame: Monthly up to 3 years
Monthly up to 3 years
Progression free survival
Time Frame: Monthly up to 2 years
Monthly up to 2 years
Time from date of diagnosis of EMP to the date of first documentation of disease
Time Frame: Monthly up to 2 years
Monthly up to 2 years
Number of adverse events
Time Frame: Monthly up to 3 years
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.
Monthly up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Chao Yang Hospital

Collaborators

Peking University People's Hospital

Investigators

  • Principal Investigator: Yuping Zhong, Doctor, Beijing Chao Yang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

January 8, 2015

First Submitted That Met QC Criteria

January 12, 2015

First Posted (Estimate)

January 13, 2015

Study Record Updates

Last Update Posted (Estimate)

January 13, 2015

Last Update Submitted That Met QC Criteria

January 12, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMA-MM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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