Pharmacokinetics and clinical outcomes of bortezomib in patients with newly diagnosed myeloma
Not Applicable
Recruiting
- Conditions
- multiple myeloma
- Registration Number
- JPRN-UMIN000006257
- Lead Sponsor
- Division of Hematology, Department of Medicine, Keio University, School of Meidicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients without consent 2) Patients with PS 3 or worse 3) ANC < 1,000/cmm 4) AST > or = 3 x upper limit, ALT > or = 3 x upper limit, TB > or = 2 x upper limit 5) Interstitial pneumonia diagnosed by imaging, pulmonary function test, or blood examination. Patients with increased level of KL-6 without any other findings suspicious of interstitial pneumonia are included. 6) Peripheral neuropathy grade 3 or higher 7) Drug allergy against bortezomib or dexamethasone 8) Primary physician thinks it is inappropriate to enroll the patient
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate (VGPR + CR + sCR) to bortezomib + dexamethasone at the end of 2nd and 4th course of treatment
- Secondary Outcome Measures
Name Time Method PFS, OS Incidence of adverse events at the end of 2nd and 4th course of treatment. Adverse events are evaluated according to NCI CTCAE ver 4. Peripheral neuropathy is also evaluated based on the modified FACT/GOG-NTx scale