Multiple myeloma
Conditions
Interventions
Eight cycles of bortezomib (1.3 mg/m2) + dexamethasone (20 mg/body) therapy on days 1, 8, and 15 in every 4 weeks
Sponsors
Japan myeloma study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG) before initial treatment with measureable M protein in serum(>=1g/dl) or urine (>=200 mg/day). 2) Relapsed or refractory myeloma after previous therapy (SD or PD). Patients who received dexamethasone can be included but bortezomib are excluded. 3) Patients without treatment for more than 4 weeks from the last therapy. 4) Age from 60 to 85 years old 5) Good performance status (0-2). Patients with PS 3 by the osteolytic lesions can be included. 6) Coexisting conditions are eligible as follows: 1. The neutrophil count >=1,000/mm3 2. The platelet count >=7.5X104/mm3 3. The Hb level >=8.0 g/dl 4. The serum AST value is less than 2.5 times from a facilities upper limit 5. The serum ALT value is less than 2.5 times from a facilities upper limit 6. The serum total bilirubin value is less than 2.0 times from a facilities upper limit 7. The serum creatinine value is less than 2.5 times from a facilities upper limit 8. The corrected calcium value <=12.5 mg/dl 9. The serum sodium value >=130 mEq/l 10. ECG neither ischemic change, Af, nor ventricular arrthymia requiring medical intervation 11. Cardiac ejection fraction >=50% 12. PaO2 >=60 mmHg or SpO2 >=93% 7) Written-informed consent has obtained.
Exclusion criteria
Exclusion criteria: 1) Previous history of hypersensitivity for Bortezomib, dexamethasone, mannitol or boron 2) Non-secretary myeloma or plasma cell leukemia 3) Peripheral neuropathy (>=grade 2) 4) Positive for HIV antibody, HBs antigen, or HCV antibody. Patients with HTLV-1 antibody can be included. 5) Uncontrollable condition of liver dysfunction, renal dysfunction, heart failure, pulmonary failure, diabetes mellitus, hypertension, or infectious disease. 6) Active and progressive double cancer within 5 years (cured carcinoma in situ either the stomach, the large intestine, or the cervical uterus are excluded from double cancer). 7) Serious mental illness such as schizophrenia 8) Pregnant woman or possibility of getting pregnant, breast-feeding 9) Interstitial pneumonitis or lung fibrosis by the clinical findings, abnormal shadow of high-resolution chest CT, high levels of KL-6, SP-A, or SP-D 10) Others (inappropriate case)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Completion rate Progression free survival Overall survival | — |
Countries
Japan
Outcome results
None listed