Phase II study of bortezomib-melphalan-prednisolone induction therapy followed by lenalidomide-plus-dexamethasone consolidation and lenalidomide maintenance for newly diagnosed patients with multiple myeloma ineligible for stem cell transplantation.
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-UMIN000009042
- Lead Sponsor
- Japan Myeloma Expert Network (J-MEN) of Japan Myeloma Network (JMN)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Not provided
1) Women in pregnancy or lactation 2) plasma cell leukemia, cardiac amyloidosis, POEMS syndrome 3) Peripheral neuropathy Grade >=2 4) Uncontrolled liver dysfunction, renal dysfunction, heart failure, impaired respiratory function, diabetes, or hyper tension 5) Concurrent diseases of tuberculosis, herpes simplex keratitis, systemic fungal disease, or active infection 6) Postcapsular cataract 7) Recent operation history 8) Myocardial infarction in past 6 months or deep vein thrombosis / pulmonary embolism within 3 months 9) Active and advanced cancer (simultaneous or within 5 years after remission) 10) Positive for hepatitis B antigen, hepatitis C antibody, or HIV antibody 11) Concurrent pneumonitis (interstitial pneumonia), lung fibrosis, or abnormal (high-resolution) chest CT findings in both lung with/without symptom 12) The patient judged inappropriate to participate in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Median progression-free survival
- Secondary Outcome Measures
Name Time Method 1) stringent complete remission rate, 2) complete remission rate, 3) response rate (partial response or better), 4) progression free survival rate at 2 years from the maintenance treatment with lenalidomide, 5) progression free survival rate at 3 years from the maintenance treatment with lenalidomide, 6) progression free survival rate at 2 years from the induction treatment, 7) progression free survival rate at 3 years from the induction treatment, 8) overall survival rate at 2 years from the induction treatment, 9) overall survival rate at 3 years from the induction treatment, 10) frequency of adverse events