Multiple Myeloma
Conditions
Keywords
Bortezomib,Thalidomide,bone metabolites
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.
Interventions
DRUGBortezomib,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.
DRUGThalidomide,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.
Sponsors
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
Second Military Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall response rate of PAD and TAD in patients with MM assessed by International Myeloma Working Group(IMWG) criteria | every treatment cycle |
Secondary
| Measure | Time frame |
|---|---|
| The concentrations of bone metabolites | every two cycles |
| 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 |
Countries
China
Outcome results
None listed