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Clinical Trials/JPRN-UMIN000016874
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

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.

Registry
who.int
Start Date
March 23, 2015
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

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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