Multiple MyelomaPhase 4NCT01249690
Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma
A Phase 4 study testing Bortezomib,Pirarubicin,Dexamethasone and Thalidomide,Pirarubicin,Dexamethasone in people with Multiple Myeloma, run by Second Military Medical University at 1 site in China.
Trial summary
The primary purpose of this study is to evaluate the efficacy of PAD-regimen and TAD-regimen in newly diagnosed multiple myeloma(MM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Bortezomib,Pirarubicin,Dexamethasone and Thalidomide,Pirarubicin,Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2010to Jun 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Hou, houjian_czyy@sina.cn
Jian Hou
About this study
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
The primary purpose of this study is to evaluate the efficacy of PAD-regimen and TAD-regimen in newly diagnosed multiple myeloma(MM).
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Bortezomib,Pirarubicin,Dexamethasone, Thalidomide,Pirarubicin,Dexamethasone
- Keywords
- Bortezomib,Thalidomide,bone metabolites
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bortezomib,Pirarubicin,DexamethasoneDrug
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.
Thalidomide,Pirarubicin,DexamethasoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| PAD | Experimental | Not described Receives: Drug: Bortezomib,Pirarubicin,Dexamethasone |
| TAD | Experimental | Not described Receives: Drug: Thalidomide,Pirarubicin,Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall response rate of PAD and TAD in patients with MM assessed by International Myeloma Working Group(IMWG) criteria
Measured: every treatment cycle
Secondary outcomes (4)
The concentrations of bone metabolites
Measured: every two cycles
chromosome examination by cytogenetic and interphase Fluorescence in situ hybridization(FISH) method
Measured: at baseline
Overall survival(OS) and progression-free survival(FPS)
Measured: two and a half year
European Organisation for Research and Treatment of Cancer Quality Of life-Questionnaires-C30 (EORTC QLQ-C30)
Measured: every two cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Peking University People's Hospital, Air Force Military Medical University, China, Xiangya Hospital of Central South University, Institute of Hematology & Blood Diseases Hospital, China, Union hospital of Fujian Medical University, Harbin Hematology and Oncology Institute, First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Beijing Jishuitan Hospital
- Investigators
- Jian Hou, PhD, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249690
- Sponsor's protocol ID
- SHCZH-2010-CT-001
- Status last verified
- May 2010
- First submitted
- 26 May 2010
- Last updated
- 30 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01249690
- Acronym / sponsor ID
- SHCZH-2010-CT-001
- Conditions
- Multiple Myeloma
- Keywords
- Bortezomib,Thalidomide,bone metabolites
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Military Medical UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Peking University People's Hospital, Air Force Military Medical University, China, Xiangya Hospital of Central South University, Institute of Hematology & Blood Diseases Hospital, China, Union hospital of Fujian Medical University, Harbin Hematology and Oncology Institute, First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Beijing Jishuitan Hospital
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 30 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the efficacy of PAD-regimen and TAD-regimen in newly diagnosed multiple myeloma(MM).
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAD | Experimental | Drug: Bortezomib,Pirarubicin,Dexamethasone |
| TAD | Experimental | Drug: Thalidomide,Pirarubicin,Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bortezomib,Pirarubicin,DexamethasoneBortezomib: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. | Drug | PAD |
| Thalidomide,Pirarubicin,DexamethasoneThalidomide: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. | Drug | TAD |
Primary outcome
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
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Hou, PhD principal investigator
Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bortezomib,Pirarubicin,Dexamethasone and Thalidomide,Pirarubicin,Dexamethasone in people with Multiple Myeloma, run by Second Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2010.