Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma

Second Military Medical University

Status and phase

Unknown

Phase 4

Conditions

Multiple Myeloma

Treatments

Drug: Thalidomide,Pirarubicin,Dexamethasone

Drug: Bortezomib,Pirarubicin,Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT01249690

SHCZH-2010-CT-001

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.