To investigate the efficacy and safety of bortezomib as maintenance therapy for untreated multiple myeloma patients ineligible for autologous stem cell transplantatio
Not Applicable
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-UMIN000007880
- Lead Sponsor
- Kanshinetsu Multiple Myeloma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
1. Non-secretory MM and plasmacell leukemia. 2. Patients HIV-HBs-and HCV-positive 3. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection. 4. Patients with a history of active malignancy during the past 5 years. 5. Patients with psychiatric disorders such as schizophrenia etc. 6. History of hypersensitivity to mannitol or boron. 7. Patient was suspected pneumonia(Interstitial pneumonia). Consult a respiratory specialist if necessary 8. Those who are considered as inappropriate to register by attending physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression-free survival
- Secondary Outcome Measures
Name Time Method Incidents of adverse events during maintenance therapy