Phase II study of a BD-HDM regimen for multiple myeloma patients
Phase 2
- Conditions
- Multiple Myeloma
- Registration Number
- JPRN-UMIN000012700
- Lead Sponsor
- ational Hospital Organization Disaster Medical Center of Japan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 96
Inclusion Criteria
Not provided
Exclusion Criteria
The exclusion criteria were a serum creatinine level2.05 mg/dL at time of high-dose therapy (HDT), 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 To investigate the safety of BD-HDM before ASCTin younger Japanese patients with MM
- Secondary Outcome Measures
Name Time Method