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Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma

NCT ID: NCT01249690

Last Updated: 2010-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma

Keywords

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Bortezomib,Thalidomide,bone metabolites

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PAD

Group Type EXPERIMENTAL

Bortezomib,Pirarubicin,Dexamethasone

Intervention Type DRUG

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.

TAD

Group Type EXPERIMENTAL

Thalidomide,Pirarubicin,Dexamethasone

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role collaborator

Air Force Military Medical University, China

OTHER

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role collaborator

Union hospital of Fujian Medical University

OTHER

Sponsor Role collaborator

Harbin Hematology and Oncology Institute

OTHER

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Beijing Jishuitan Hospital

OTHER

Sponsor Role collaborator

Second Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Shanghai Changzheng Hospital, the Second Military Medical University

Principal Investigators

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Jian Hou, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Changzheng Hospital

Locations

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Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Hou

Role: primary

Other Identifiers

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SHCZH-2010-CT-001

Identifier Type: -

Identifier Source: org_study_id