Bortezomib induction, consolidation and maintenance therapy in patients with newly diagnosed multiple myeloma
Phase 2
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-UMIN000010542
- Lead Sponsor
- Kyoto University Hematology Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Not provided
Exclusion Criteria
1, Non-secretary multiplemyeloma and plasma cell leukemia 2, HIV antibody positive, HBsAg positive, HBV-DNA positive, and HCV antibody positive. 3, Known hypersensivity to mannitol or boron. 4, Pregnant or breast-feeding women. 5, Active malignancy within last 5 years. 6, Serious psychiatric disordes or illness that could potentially interfere with the completion of treatment according to this protocol. 7, Active infection or serious co-morbid medical condition. 8, Interstitial pneumonitis or lung fibrosis by the clinical findings, abnormal shadow of chest CT. 9, History of sever hypersensivity to drugs. 10,Participants who are recoginized as inadaptable for this protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CR rate 100 days after autologous PBSCT
- Secondary Outcome Measures
Name Time Method ORR after indecution therapy ORR after PBSCH ORR after 100 days after PBSCT ORR after consolidation therapy ORR during maiteinance therapy at 6, 12, 18, 24 months 2-years progression free survival 2 years overall survival Time to pregression Incidence of adverse events mCR rate after induction, PBSCH, PBSCT, consolidation and maintenance therapy Detection of Minimal residual disease in PBSCH products Numer of CD34 cells harvested Incidence of graft failure Completion rate of maintenance therapy