bortezomib- and thalidomide-na&
Conditions
Interventions
A: bortezomib (1.3mg/m2, days 1,4,8,11) and dexamethasone (20mg/day, days 1,2,4,5,8,9,11,12 for cycles 1-2, days 1,2,4,5 for cycles 3-8 ) administered for eight 21-day cycles as induction therapy, fol
Sponsors
Japan Clinical Oncology Group(JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) diagnosed as having symptomatic multiple myeloma before initial treatment 2) relapsed and/or refractory cases after at least one prior chemotherapy 3) Aged 20 to 79 years old 4) either menopausal women aged at 50 or older, women after hysterectomy, or women after bilateral ovariectomy 5) men who agreed to use contraception 6) performance status: 0-2, or 3 due to osteolytic lesions alone 7) having measurable paraprotein defined as serum monoclonal immunoglobulin concentration of at least 1.0g/dL of IgG, or at least 0.5g/dL of absolute serum concentration of IgA/IgD, or urinary excretion of at least 0.2g of paraprotein per 24 hours in spite of the type of myeloma 8) having no prior treatment with bortezomib and that with thalidomide 9) at least 22 days have passed after the prior therapy 10) having neither of the following complications: plasma cell leukemia, cardiac amyloidosis, gastrointestinal amyloidosis 11) having no current complications of deep vein thrombosis or pulmonary embolism 12) not received allogeneic hematopoietic stem cell transplantation 13) absolute neutrophil count: no less than 1,200/mm3, platelet count: no less than 60,000/mm3, hemoglobin concentration: at least 7.0 g/dL, AST/ALT: no more than 100IU/l, total bilirubin: 1.8 mg/dL or below, serum creatinene: 2.5 mg/dL or below, corrected serum calcium: 12.5 mg/dL or below, serum sodium: 130 mEq/L or above, PaO2 (room air): at least 70 torr, serum FDP: 10 ug/dL or below, ECG: neither ischemic change nor arrhythmia reqiuring medical intervention, cardiac ejection fraction: at least 50% 14) written informed consent by the patient
Exclusion criteria
Exclusion criteria: 1) synchronous or metachronous malignancy 2) active infection 3) febrile over 38oC 4) pregnant or nursing women 5) psychological disturbance 6) continued treatment with steroids for non-malignant disorders 7) insulin-dependent or uncontrollable diabetes mellitus 8) uncontrollable hypertension 9) HBs-Ag positive or HCV-Ab positive 10) HIV-Ab positive 11) interstitial pneoumonia, pulmonary fibrosis, severe pulmonary edema, or severe pleural effusion on chest CT 12) grade 2 or higher peripheral neuropathy, or grade 1 or higher neuralgia 13) glaucoma 14) allergic history to borate or mannitol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year progression free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events, serious adverse events, best response rate, progression free survival, overall survival | — |
Countries
Japan
Contacts
Public ContactShinsuke Iida
JCOG0904 Coordinating Office Department of Hematology and Oncology, Nagoya City University Hospital
Outcome results
None listed