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Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Second Military Medical University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01249690
First Posted: November 30, 2010
Last Update Posted: November 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Zhejiang University
Peking University People's Hospital
Fourth Military Medical University
Xiangya Hospital of Central South University
Institute of Hematology & Blood Diseases Hospital
Union hospital of Fujian Medical University
Harbin Hematology and Oncology Institute
First Affiliated Hospital, Sun Yat-Sen University
Beijing Jishuitan Hospital
Information provided by:
Second Military Medical University
  Purpose
The primary purpose of this study is to evaluate the efficacy of PAD-regimen and TAD-regimen in newly diagnosed multiple myeloma(MM).

Condition Intervention Phase
Multiple Myeloma Drug: Bortezomib,Pirarubicin,Dexamethasone Drug: Thalidomide,Pirarubicin,Dexamethasone Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Second Military Medical University:

Primary Outcome Measures:
  • The overall response rate of PAD and TAD in patients with MM assessed by International Myeloma Working Group(IMWG) criteria [ Time Frame: every treatment cycle ]

Secondary Outcome Measures:
  • The concentrations of bone metabolites [ Time Frame: every two cycles ]
  • chromosome examination by cytogenetic and interphase Fluorescence in situ hybridization(FISH) method [ Time Frame: at baseline ]
  • Overall survival(OS) and progression-free survival(FPS) [ Time Frame: two and a half year ]
  • European Organisation for Research and Treatment of Cancer Quality Of life-Questionnaires-C30 (EORTC QLQ-C30) [ Time Frame: every two cycles ]

Estimated Enrollment: 100
Study Start Date: June 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PAD Drug: Bortezomib,Pirarubicin,Dexamethasone
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.
Experimental: TAD Drug: Thalidomide,Pirarubicin,Dexamethasone
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249690


Locations
China, Shang Hai
Shanghai Changzheng Hospital Recruiting
Shang Hai, Shang Hai, China, 200003
Contact: Hou       houjian_czyy@sina.cn   
Principal Investigator: Jian Hou         
Sponsors and Collaborators
Second Military Medical University
Zhejiang University
Peking University People's Hospital
Fourth Military Medical University
Xiangya Hospital of Central South University
Institute of Hematology & Blood Diseases Hospital
Union hospital of Fujian Medical University
Harbin Hematology and Oncology Institute
First Affiliated Hospital, Sun Yat-Sen University
Beijing Jishuitan Hospital
Investigators
Principal Investigator: Jian Hou, PhD Shanghai Changzheng Hospital
  More Information

Responsible Party: Hou Jian/Director of department of hematology, Shanghai Changzheng Hospital, the Second Military Medical University
ClinicalTrials.gov Identifier: NCT01249690     History of Changes
Other Study ID Numbers: SHCZH-2010-CT-001
First Submitted: May 26, 2010
First Posted: November 30, 2010
Last Update Posted: November 30, 2010
Last Verified: May 2010

Keywords provided by Second Military Medical University:
Bortezomib,Thalidomide,bone metabolites

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Pirarubicin
Bortezomib
Thalidomide
Doxorubicin
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists