Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma
This study is currently recruiting participants.
Verified May 2010 by Second Military Medical University
Sponsor:
Second Military Medical University
Collaborators:
Zhejiang University
Peking University People's Hospital
Xijing Hospital of Fourth Military Medical University
Xiangya Hospital of Central South University
Institute of Hematology & Blood Diseases Hospital
Union hospital of Fujian Medical University
Harbin Institute of Hematology and Oncology
First Affiliated Hospital, Sun Yat-Sen University
Beijing Jishuitan Hospital
Information provided by:
Second Military Medical University
ClinicalTrials.gov Identifier:
NCT01249690
First received: May 26, 2010
Last updated: November 29, 2010
Last verified: May 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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:
Drug Information available for:
Dexamethasone
Thalidomide
Dexamethasone acetate
Dexamethasone sodium phosphate
Bortezomib
U.S. FDA Resources
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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The concentrations of bone metabolites [ Time Frame: every two cycles ] [ Designated as safety issue: No ]
- chromosome examination by cytogenetic and interphase Fluorescence in situ hybridization(FISH) method [ Time Frame: at baseline ] [ Designated as safety issue: No ]
- Overall survival(OS) and progression-free survival(FPS) [ Time Frame: two and a half year ] [ Designated as safety issue: No ]
- European Organisation for Research and Treatment of Cancer Quality Of life-Questionnaires-C30 (EORTC QLQ-C30) [ Time Frame: every two cycles ] [ Designated as safety issue: Yes ]
| 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Xijing Hospital of Fourth Military Medical University
Xiangya Hospital of Central South University
Institute of Hematology & Blood Diseases Hospital
Union hospital of Fujian Medical University
Harbin Institute of Hematology and Oncology
First Affiliated Hospital, Sun Yat-Sen University
Beijing Jishuitan Hospital
Investigators
| Principal Investigator: | Jian Hou, PhD | Shanghai Changzheng Hospital |
More Information
No publications provided
| 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 |
| Study First Received: | May 26, 2010 |
| Last Updated: | November 29, 2010 |
| Health Authority: | China: Ethics Committee |
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 Dexamethasone 21-phosphate Pirarubicin Bortezomib Thalidomide Doxorubicin BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013