Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01249690
• Other study ID #: SHCZH-2010-CT-001
• Status: Recruiting
• Phase: Phase 4
• First received: May 26, 2010
• Last updated: November 29, 2010
• Start date: June 2010
• Est. completion date: June 2014

Study information

• Verified date: May 2010
• Source: Second Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Shanghai Changzheng Hospital	Shang Hai	Shang Hai

Sponsors (10)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The overall response rate of PAD and TAD in patients with MM assessed by International Myeloma Working Group(IMWG) criteria		every treatment cycle	No
Secondary	The concentrations of bone metabolites		every two cycles	No
Secondary	chromosome examination by cytogenetic and interphase Fluorescence in situ hybridization(FISH) method		at baseline	No
Secondary	Overall survival(OS) and progression-free survival(FPS)		two and a half year	No
Secondary	European Organisation for Research and Treatment of Cancer Quality Of life-Questionnaires-C30 (EORTC QLQ-C30)		every two cycles	Yes