relapse or refractory multiple myeloma
Conditions
Interventions
bortezomib 1.0mg/m2,iv, day1,4,8,11 doxorubicin 9mg/m2, iv, day1-4 dexamethasone 20mg,p.o. day1,2,4,5,8,9,11,12 every 3 weeks, total 6 cycles
Sponsors
Department of Hematology and Respiratory Medicine, Kochi University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have been diagnosed with symptomatic multiple myeloma according to the diagnostic criteria of the International Myeloma Working Group (IMWG) 2. Relapse/refractory multiple myeloma 3. Aged 20 to 80 years old 4. Performance status 0-3 5. Adequate organ function ATL and AST of less than 5 times the ULN, total bilirubin of less than 3 times the ULN 6.serum creatinine less than 3 times the ULN 7. ECG: neither ischemic change nor arrhythmia requiring medical intervention 8. PaO2 (room air): at least 60 torr 9. Give voluntary written informed consent before enrollment
Exclusion criteria
Exclusion criteria: 1. Patients who have a serious active infection 2. Patients who have complication of active double cancer 3. Women who are or may be pregnant or are nursing 4. Patients with grade 2 or severer peripheral neuropathy or peripheral neurogenic pain (CTCAE v4.0) 5. Patient diagnosed with interstitial pneumonia in high resolution CT, and judged to improper to administer bortezomib 6. Other patients who are unfit for enrollment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate, safety | — |
Countries
Japan
Contacts
Public ContactMizu Sakai
Kochi univercity Department of Hematology and Respiratory Medicine
Outcome results
None listed