The efficacy and safety of subcutaneous injection of bortezomib combined with doxorubicin and dexamethasone for untreated multiple myeloma patients.
Phase 2
Recruiting
- Conditions
- multiple myeloma
- Registration Number
- JPRN-UMIN000007803
- Lead Sponsor
- ational Hospital Organization Disaster Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
The exclusion criteria were a serum creatinine level>2.05 mg/dL, liver dysfunction (e.g., a serum total bilirubin level>2.0 mg/dL, or serum aspartate/alanine aminotransferase or alkaline phosphatase levels more than 2.5 times the upper limit of normal), grade 3 or worse peripheral neuropathy, significant comorbidity that would preclude ASCT, poor performance status (>grade 3), and a history of any other malignancy with the exception of basal cell carcinoma and stage I cervical cancer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy
- Secondary Outcome Measures
Name Time Method safety complete response rate progression free survival Blood concentration of bortezomib overall survival