Know Cancer

or
forgot password

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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The overall response rate of PAD and TAD in patients with MM assessed by International Myeloma Working Group(IMWG) criteria

Outcome Time Frame:

every treatment cycle

Safety Issue:

No

Principal Investigator

Jian Hou, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shanghai Changzheng Hospital

Authority:

China: Ethics Committee

Study ID:

SHCZH-2010-CT-001

NCT ID:

NCT01249690

Start Date:

June 2010

Completion Date:

June 2014

Related Keywords:

  • Multiple Myeloma
  • Bortezomib,Thalidomide,bone metabolites
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location