Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma

Phase 4

• Conditions: Multiple Myeloma
• Interventions: Drug: Bortezomib,Pirarubicin,Dexamethasone; Drug: Thalidomide,Pirarubicin,Dexamethasone

• Registration Number: NCT01249690
• Lead Sponsor: Second Military Medical University

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.

Study Timeline

• Status Verified: 2010-05
• Study First Submitted: 2010-05-26
• Study Start: 2010-06
• Study First Submitted QC: 2010-11-29
• Last Update Submitted: 2010-11-29
• Study First Posted: 2010-11-30
• Last Update Posted: 2010-11-30
• Primary Completion: 2012-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAD	Bortezomib,Pirarubicin,Dexamethasone	-
TAD	Thalidomide,Pirarubicin,Dexamethasone	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Changzheng Hospital; 🇨🇳 Shang Hai, Shang Hai, China