Phase II Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Older Than 75 Years With Alternating Bortezomib/dexamethasone (Bd) With Lenalidomide/dexamethasone (Ld).
- Conditions
- Multiple Myeloma
- Registration Number
- JPRN-UMIN000013773
- Lead Sponsor
- Clinical Hematlogy Study Group of National Hospital Organization (CHSGONHO)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
1. Plasma cell leukemia, cardiac amyloidosis, POEMS syndrome. 2. Patients has >= Grade 2 peripheral neuropathy. 3. Uncontrolled liver dysfunction, renal dysfunction, heart failure, impaired respiratory function, diabetes, or hyper tension. 4. Concurrent diseases of tuberculosis, herpes simplex keratitis, systemic fungal disease, or active infection. 5. Recent operation history. 6. Myocardial infarction within 6 months of enrolment or deep vein thrombosis/ pulmonary embolism within 3 years. 7. Patient has active and advanced double cancer (simultaneous or within 5 years post remission). 8. Positive for hepatitis B antigen, hepatitis C antibody, or HIV antibody. 9. Patients with pneumonitis (interstitial pneumonia) or pulmonary fibrosis in clinical, or abnormal (high-resolution) chest CT findings bilateral lung regardless of the presence or absence of symptoms. 10. Patient has hypersensitivity to boron or mannitol. 11. Patient has psychiatric diseases or psychological symptoms. 12. Patient judged inappropriate to participate in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate (ORR)
- Secondary Outcome Measures
Name Time Method Safety (toxicity and tolerability) Continuation rate of treatment Complete response rate Very good partial response rate Progression-free survival rate (PFS) Overall survival rate (OS) Time to response (TTR)