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Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT01249690
Recruitment Status : Unknown
Verified May 2010 by Second Military Medical University.
Recruitment status was:  Recruiting
First Posted : November 30, 2010
Last Update Posted : November 30, 2010
Information provided by:

Study Description
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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Bortezomib,Pirarubicin,Dexamethasone Drug: Thalidomide,Pirarubicin,Dexamethasone Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : June 2010
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2014

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. The concentrations of bone metabolites [ Time Frame: every two cycles ]
  2. chromosome examination by cytogenetic and interphase Fluorescence in situ hybridization(FISH) method [ Time Frame: at baseline ]
  3. Overall survival(OS) and progression-free survival(FPS) [ Time Frame: two and a half year ]
  4. European Organisation for Research and Treatment of Cancer Quality Of life-Questionnaires-C30 (EORTC QLQ-C30) [ Time Frame: every two cycles ]

Eligibility Criteria

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

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

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
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 Posted: November 30, 2010    Key Record Dates
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
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists