Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma

November 29, 2010 updated by: Second Military Medical University

Study of Efficacy of PAD-regimen(Bortezomib,Pirarubicin and Dexamethasone) and TAD-regimen(Thalidomide,Pirarubicin and Dexamethasone) in Newly Diagnosed Multiple Myeloma,Influence in Concentration of Bone Metabolites,and the Relations With Different Cytogenetic and Molecular Biological Changes

The primary purpose of this study is to evaluate the efficacy of PAD-regimen and TAD-regimen in newly diagnosed multiple myeloma(MM).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Multiple myeloma (MM) is a malignant tumor with abnormal proliferation of monoclonal plasma cells in bone marrow. Bone damage is one of the characteristic clinical manifestations. Myeloma plasma cells and bone marrow microenvironment are the targets of thalidomide and bortezomib. The regimens based on them as first-line treatments of MM have greatly improved efficacy and prolonged the survival of MM patients. But whether the regimens can prevent and treat bone complications of MM patients or improve the quality of life is not clear. By evaluating the efficacy of PAD-regimen(Bortezomib,Pirarubicin and Dexamethasone) and TAD-regimen(Thalidomide,Pirarubicin and Dexamethasone) in MM and the effect of them on bone lesions, this study can provide evidence of evidence-based medicine for MM treatment.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

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
    • Shang Hai
      • Shang Hai, Shang Hai, China, 200003
        • Recruiting
        • Shanghai Changzheng Hospital
        • Contact:
        • Principal Investigator:
          • Jian Hou

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:

  • Subjects with symptomatic and measurable newly diagnosed Multiple Myeloma.
  • Age > 18 years, KPS ≥ 60, and life expectancy of at least 3 months.
  • Subjects must meet all of the following criteria within 14 days before starting therapy:

PLT≥50×109/L, Hb≥70 g/L, ANC≥0.75×109/L

  • Subjects (or their legally acceptable representatives) must signed an informed consent document.

Exclusion Criteria:

  • Severe cardiovascular disease ; HIV infection, or positive HBsAg, or active hepatitis C; HBV-DNA>104; hepatic functional parameter>2.5 times the upper limit of institutional laboratory normal.
  • Grade 2 or more severe peripheral neuropathy or neuropathic pain; Grade 2 or more severe impaired hepatic and kidney function.
  • Patient has radiotherapy or major surgery within 30 days before enrollment.
  • Patient has hypersensitivity to boron, mannitol or thalidomide.
  • Pregnant or breastfeeding women, or subject unwilling to use a method for contraception during the study.

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PAD
Drug: Bortezomib,Pirarubicin,Dexamethasone
Bortezomib:1.3mg/m2,on day 1,4,8 and 11 of each 28 day cycle; Pirarubicin:10mg,on day 1 to 4 of each 28 day cycle; Dexamethasone:20mg,on day 1 to 4 and 8 to 11 of each 28 day cycle; Number of cycles: up to 8 cycles.
EXPERIMENTAL: TAD
Drug: Thalidomide,Pirarubicin,Dexamethasone
Thalidomide:200mg/d, everyday; Pirarubicin:10mg,on day 1 to 4 of each 28 day cycle; Dexamethasone:20mg,on day 1 to 4 and 8 to 11 of each 28 day cycle; Number of cycles: up to 8 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The overall response rate of PAD and TAD in patients with MM assessed by International Myeloma Working Group(IMWG) criteria
Time Frame: every treatment cycle
every treatment cycle

Secondary Outcome Measures

Outcome Measure
Time Frame
The concentrations of bone metabolites
Time Frame: every two cycles
every two cycles
chromosome examination by cytogenetic and interphase Fluorescence in situ hybridization(FISH) method
Time Frame: at baseline
at baseline
Overall survival(OS) and progression-free survival(FPS)
Time Frame: two and a half year
two and a half year
European Organisation for Research and Treatment of Cancer Quality Of life-Questionnaires-C30 (EORTC QLQ-C30)
Time Frame: every two cycles
every two cycles

Collaborators and Investigators

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

Sponsor

Second Military Medical University

Collaborators

Xiangya Hospital of Central South University
Peking University People's Hospital
First Affiliated Hospital, Sun Yat-Sen University
Institute of Hematology & Blood Diseases Hospital
Air Force Military Medical University, China
Zhejiang University
Beijing Jishuitan Hospital
Union hospital of Fujian Medical University
Harbin Hematology and Oncology Institute

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

June 1, 2010

Primary Completion (ANTICIPATED)

June 1, 2012

Study Completion (ANTICIPATED)

June 1, 2014

Study Registration Dates

First Submitted

May 26, 2010

First Submitted That Met QC Criteria

November 29, 2010

First Posted (ESTIMATE)

November 30, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 30, 2010

Last Update Submitted That Met QC Criteria

November 29, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHCZH-2010-CT-001

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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