Elderly patients or non-elderly patients refusing transplant with untreated symptomatic myeloma
Conditions
Interventions
Arm A: modified PETHEMA-MPB therapy consists of nine cycles: one cycle of subcutaneous or intravenous bortezomib given twice per week for 6 weeks (1.3 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32), p
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as having symptomatic multiple myeloma 2) Aged 65 to 79 years old, or 20 to 64 years old who refused high-dose therapy followed by autologous stem-cell transplantation 3) Untreated for multiple myeloma 4) Having measurable paraprotein defined as serum monoclonal immunoglobulin concentration of at least 1.0 g/dL of IgG, or at least 0.5 g/dL of absolute serum concentration of IgA/IgD, or urinary excretion of at least 0.2 g of paraprotein per 24 hours regardless of the type of myeloma 5) Not having plasma cell leukemia 6) Having neither of cardiac amyloidosis nor gastrointestinal amyloidosis 7) Performance status: 0-2, or 3 due to osteolytic lesions alone 8) Absolute neutrophil count: no less than 1,000/mm3, platelet count: no less than 75,000/mm3, hemoglobin concentration: at least 8.0 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, PaO2 (room air) at least 70 torr, ECG: neither ischemic change nor arrhythmia requiring medical intervention, cardiac ejection fraction: at least 50% 9) Peripheral neuropathy of grade 1 or less and no neuralgia 10) Written informed consent by the patient including contraception
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous malignancy 2) Active infection 3) Pregnant or nursing women 4) Psychiatric disease 5) Continuous systemic treatment with steroids for non-malignant disorders 6) Insulin-dependent or uncontrollable diabetes mellitus 7) Uncontrollable hypertension 8) HBs-Ag positive or HCV-Ab positive 9) HIV-Ab positive 10) Interstitial pneoumonia, pulmonary fibrosis, severe pulmonary emphysema, or severe pleural effusion on chest CT 11) Uncontrollable Glaucoma 12) Allergic history to borate or mannitol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| proportion of treatment completion, overall response rate, stringent complete response rate, overall survival, progression-free survival, time to next treatment, adverse events, serious adverse events, efficacy according to chromosomal translocation-associated protooncogene expression | — |
Countries
Japan
Contacts
Public ContactDai Maruyama
JCOG1105 Coordinating Office Department of Hematology, National Cancer Center Hospital
Outcome results
None listed