A prospective study to validate the efficacy on the induction, consolidation, and maintenance therapy for the elderly multiple myeloma patients.
Phase 2
- Conditions
- Multiple myeloma patients over the age of 70.
- Registration Number
- JPRN-UMIN000010853
- Lead Sponsor
- niversity of Teikyo School of Medicine, Internal medicine, department of Hematology/Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who are not eligible for this study are: 1. may be pregnant or are pregnant. 2. suffered from an active cancer within the last five years. 3. HBs antigen positive, HCV-antibody positive, HIV-antibody positive 4. severe psychometric dysfunction 5. with interstitial pneumonitis 6. with a severe active infection 7. with a severe pulmonary dysfunction; PaO2/FiO2 ratio <200 8. with a severe cardiac dysfunction; percent fractional shortening <15% 9. judged unsuitable by the doctor 10. cannot take an oral administration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy at the end of two sequential induction therapies Efficacy includes over-all response rate, VGPR and above CR ratio by IMWG uniform response criteria.
- Secondary Outcome Measures
Name Time Method Safety profile of induction, consolidation, and maintenance therapy, rate of continuation in maintenance therapy, improvement of efficacy during consolidation and maintenance therapy, progression free survival, prognosis of 75 years of age or older