Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma

Second Military Medical University100 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Multiple Myeloma

Interventions

Bortezomib,Pirarubicin,DexamethasoneDRUG

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,DexamethasoneDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

The concentrations of bone metabolites

Time frame: every two cycles

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

Time frame: at baseline

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

Time frame: 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

Data from ClinicalTrials.gov

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