JPRN-UMIN000016874
Recruiting
未知
Phase1/2study evaluating safety and efficacy of bortezomib-lenalidomid-dexamethasone induction therapy followed by lenalidomide-dexamethasone consolidation and lenalidomide maintenance for newly diagnosed patients with multiple myeloma eligible for stem cell transplantation.
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital0 sites30 target enrollmentMarch 23, 2015
ConditionsMultiple myeloma
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Multiple myeloma
- Sponsor
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.multiple myeloma defined by IMWG criteria.
- •2\.aged from 20 to 65 years old.
- •3\.PS(ECOG)0\-2\.(Patients with poor P.S. by bone pain accompanying myeloma can be included.)
- •4\.Main organ function is maintained
- •Absolute neutrophil counts \>1000/mm
- •Platelet counts\>75,000/mm3
- •T\-bil \< 3 times upper limit of normal standard
- •AST and ALT \< 5 times upper limit of normal standard
- •Serum Creatinine \<2mg/dl
- •5\. The patient who lives more than three months
Exclusion Criteria
- •1\.non\-secretary multiple myeloma or plasmacytoma or plasma cell leukemia, POEMS syndrom
- •2\.HBs antigen,HCV antibody positive
- •3\.HTLV\-1 antibody, HIV antibody positive
- •4\.Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection.
- •5\.Patients with a history of active malignancy during the past 5 years.
- •6\.Patients with psychiatric disorders such as schizophrenia etc.
- •7\.Pregnant women, pre\-menopausal women, and lactating women.
- •8\.History of hypersensitivity to mannitol or boron.
- •9\.dialysis patient
- •10\.Patient of the vein thrombosis
Outcomes
Primary Outcomes
Not specified
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