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Trial Title:
Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma
NCT ID:
NCT01249690
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Thalidomide
Dexamethasone
Dexamethasone acetate
Bortezomib
Pirarubicin
Doxorubicin
BB 1101
Conditions: Keywords:
Bortezomib,Thalidomide,bone metabolites
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Bortezomib,Pirarubicin,Dexamethasone
Description:
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.
Arm group label:
PAD
Intervention type:
Drug
Intervention name:
Thalidomide,Pirarubicin,Dexamethasone
Description:
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.
Arm group label:
TAD
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Changzheng Hospital
Address:
City:
Shang Hai
Zip:
200003
Country:
China
Status:
Recruiting
Contact:
Last name:
Hou
Email:
houjian_czyy@sina.cn
Investigator:
Last name:
Jian Hou
Email:
Principal Investigator
Start date:
June 2010
Completion date:
June 2014
Lead sponsor:
Agency:
Second Military Medical University
Agency class:
Other
Collaborator:
Agency:
Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Peking University People's Hospital
Agency class:
Other
Collaborator:
Agency:
Air Force Military Medical University, China
Agency class:
Other
Collaborator:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Collaborator:
Agency:
Union hospital of Fujian Medical University
Agency class:
Other
Collaborator:
Agency:
Harbin Hematology and Oncology Institute
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Beijing Jishuitan Hospital
Agency class:
Other
Source:
Second Military Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01249690
