Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma

• Status: Unknown status
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Military Medical University
• Collaborators: Air Force Military Medical University, China; Beijing Jishuitan Hospital; First Affiliated Hospital, Sun Yat-Sen University; Fourth Military Medical University; Harbin Hematology and Oncology Institute; Harbin Institute of Hematology and Oncology; Institute of Hematology & Blood Diseases Hospital; Peking University People's Hospital; Union hospital of Fujian Medical University; Xiangya Hospital of Central South University; Zhejiang University
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Pirarubicin; Thalidomide

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.