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Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Bortezomib,Pirarubicin,Dexamethasone

Thalidomide,Pirarubicin,Dexamethasone

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Bortezomib,Thalidomide,bone metabolites

Eligibility Criteria

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

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.

Sites / Locations

Shanghai Changzheng HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

PAD

TAD

Arm Description

Outcomes

Primary Outcome Measures

The overall response rate of PAD and TAD in patients with MM assessed by International Myeloma Working Group(IMWG) criteria

Secondary Outcome Measures

The concentrations of bone metabolites

chromosome examination by cytogenetic and interphase Fluorescence in situ hybridization(FISH) method

Overall survival(OS) and progression-free survival(FPS)

European Organisation for Research and Treatment of Cancer Quality Of life-Questionnaires-C30 (EORTC QLQ-C30)

Full Information

NCT ID

NCT01249690

First Posted

May 26, 2010

Last Updated

November 29, 2010

Sponsor

Second Military Medical University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01249690

Brief Title

Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Unknown status

Study Start Date

June 2010 (undefined)

Primary Completion Date

June 2012 (Anticipated)

Study Completion Date

June 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Second Military Medical University

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Bortezomib,Thalidomide,bone metabolites

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PAD

Arm Type

Experimental

Arm Title

TAD

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Bortezomib,Pirarubicin,Dexamethasone

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Thalidomide,Pirarubicin,Dexamethasone

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

The concentrations of bone metabolites

Time Frame

every two cycles

Title

chromosome examination by cytogenetic and interphase Fluorescence in situ hybridization(FISH) method

Time Frame

at baseline

Title

Overall survival(OS) and progression-free survival(FPS)

Time Frame

two and a half year

Title

European Organisation for Research and Treatment of Cancer Quality Of life-Questionnaires-C30 (EORTC QLQ-C30)

Time Frame

every two cycles

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian Hou, PhD

Organizational Affiliation

Shanghai Changzheng Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai Changzheng Hospital

City

Shang Hai

State/Province

Shang Hai

ZIP/Postal Code

200003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hou

houjian_czyy@sina.cn

First Name & Middle Initial & Last Name & Degree

Jian Hou

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma

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