Clinical trial NCT01249690: Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Multiple Myeloma
Keywords: Bortezomib,Thalidomide,bone metabolites
Lead sponsor: Second Military Medical University
Sponsor class: OTHER
Collaborators: name: Zhejiang University
name: Peking University People's Hospital
name: Air Force Military Medical University, China
name: Xiangya Hospital of Central South University
name: Institute of Hematology & Blood Diseases Hospital, China
name: Union hospital of Fujian Medical University
name: Harbin Hematology and Oncology Institute
name: First Affiliated Hospital, Sun Yat-Sen University
name: Beijing Jishuitan Hospital
First posted: 2010-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The overall response rate of PAD and TAD in patients with MM assessed by International Myeloma Working Group(IMWG) criteria
timeFrame: every treatment cycle
Secondary outcomes:
measure: The concentrations of bone metabolites
timeFrame: every two cycles
measure: chromosome examination by cytogenetic and interphase Fluorescence in situ hybridization(FISH) method
timeFrame: at baseline
measure: Overall survival(OS) and progression-free survival(FPS)
timeFrame: two and a half year
measure: European Organisation for Research and Treatment of Cancer Quality Of life-Questionnaires-C30 (EORTC QLQ-C30)
timeFrame: every two cycles
Other outcomes:
Locations:
city: Shang Hai
country: China
facility: Shanghai Changzheng Hospital
state: Shang Hai
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Jian Hou, PhD
role: PRINCIPAL_INVESTIGATOR
References: