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Phase I study of weekly bortezomib for patients with recurrent or refractory multiple myeloma

Not Applicable
Conditions
Multiple myeloma
Registration Number
JPRN-UMIN000002922
Lead Sponsor
PO IB-HOPE
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
12
Inclusion Criteria

Not provided

Exclusion Criteria

1) CNS involvement 2) History of severe drug allergy 3) Active infectious diseases 4) HBs antigen or HCV antibody or HIV antibody positive 5) Significant complications which include cardiac dysfunction, liver cirrhosis, uncontrolled diabetes, renal failure 6) Interstitial pneumonitis 7) History of other active malignancy 8) Severe mental disorder

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The dose-limiting toxicity of weekly bortezomib during the first cycle.
Secondary Outcome Measures
NameTimeMethod
Response rate, progression-free survival, overall survival, and adverse effects.
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