Status:
UNKNOWN
Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma
Lead Sponsor:
Second Military Medical University
Collaborating Sponsors:
Zhejiang University
Peking University People's Hospital
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01249690
Start Date
June 1 2010
End Date
June 1 2014
Last Update
November 30 2010
Active Locations (1)
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1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003