Multiple myeloma patients over the age of 70.
Conditions
Interventions
1st induction therapy Bortezomib 1.0 mg/m2 on days 1, 8, 15, and 22 injected subcutaneously (sc) Dexamethasone 8 mg/body on days 1, 8, 15, and 22 per os (po) or intravenous drip-injection (div) 1st
interval, 3 cycles Consolidation and maintenance Bortezomib 1.0 mg/m2 on days 1, and 15 sc Thalidomide 50 mg/body every other day po One cycle for 5 weeks'
interval, 6 cycles
Sponsors
University of Teikyo School of Medicine, Internal medicine, department of Hematology/Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible who are diagnosed as a symptomatic (active) MM referred to International Myeloma Working Group (IMWG) criteria, and 1. There are no pre-treated MM therapies without steroid administration or radiation therapy due to hyper calcemia or relieving symptoms. 2. Age at 70 years old or older 3. Karnofsky performance status > 50%(PS 0-2). If patients with PS 3 or 4 or KS >20% patients induced of fructure only, can enroll in this study. 4. Laboratory data 1) Absolute neutrophil count > 1,000 /mm3 2) Platelet count > 50,000 /mm3 3) Hb > 7.0 g/dL 4) AST, ALT < 5 times the ULN 5) T-Bil < 3 times the ULN 6) Cr < 2.5 mg/dL 5. No dysfunctions due to a symptomatic pre-existing sensory neuropathy NCICTC grade 3-4 6. In the case of women, after menopause, surgical contraception or patients who are not willing to use birth control during the study. 7. can comply to register (Lenalidomide, Thalidomide drug management program) to RevMate, TERMS
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShirasaki Ryosuke
University of Teikyo School of Medicine Internal medicine, department of Hematology/Oncology
Outcome results
None listed