Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma

NCT01249690 | Unknown Phase 4 DMC

• 1 other identifier: SHCZH-2010-CT-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Myeloma

Keywords

Bortezomib,Thalidomide,bone metabolites

Outcome Measures

Primary Outcomes (1)

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

  every treatment cycle

Secondary Outcomes (4)

• The concentrations of bone metabolites

  every two cycles

• chromosome examination by cytogenetic and interphase Fluorescence in situ hybridization(FISH) method

  at baseline

• Overall survival(OS) and progression-free survival(FPS)

  two and a half year

• European Organisation for Research and Treatment of Cancer Quality Of life-Questionnaires-C30 (EORTC QLQ-C30)

  every two cycles

Study Arms (2)

PAD

EXPERIMENTAL

Drug: Bortezomib,Pirarubicin,Dexamethasone

TAD

EXPERIMENTAL

Drug: Thalidomide,Pirarubicin,Dexamethasone

Interventions

Bortezomib,Pirarubicin,Dexamethasone DRUG

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.

PAD

Thalidomide,Pirarubicin,Dexamethasone DRUG

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.

TAD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Military Medical University: lead
• Zhejiang University: collaborator
• Peking University People's Hospital: collaborator
• Air Force Military Medical University, China: collaborator
• Xiangya Hospital of Central South University: collaborator
• Institute of Hematology & Blood Diseases Hospital, China: collaborator
• Union hospital of Fujian Medical University: collaborator
• Harbin Hematology and Oncology Institute: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Beijing Jishuitan Hospital: collaborator

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jian Hou, PhD

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: November 30, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2014
• Last Updated: November 30, 2010

Record last verified: 2010-05

Locations

CN (1)