multiple myeloma
Conditions
Interventions
1. Induction phase (42 days): Bortezomib 1.3 mg/m2, subcutaneouslly (Days 1, 4, 8, 11, 22, 25, 29 and 32)
Melphalan 0.18 mg/kg, orally (Days 1, 2, 3 and 4)
Prednisolone 40 mg/m2, orally (Days 1, 2, 3 and 4). 2. Consolidation phase (35 days/cycle): Bortezomib 1.3 mg/m2, subcutaneously (Days 1, 8, 15 and 22)
Prednisolone 40 mg/m2, orally (Days 1, 2, 3 and 4). This treatment will be repeated 6 to 9 cycles until cumulative dose of bortezomib reach to 40 mg/m2. 3. Maintenance phase (28 days/cycle): Bortez
Sponsors
Toyonaka Municipal Hospital
Department of Hematology and Oncology, Osaka University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with multiple myeloma diagnosed from clinical manifestations, laboratory tests, or bone marrow aspiration. 2. Untreated patients having no history of pretreatment before enrollment (Local radiotherapy is not considered as a pretreatment). 3. Patients that attending physicians consider as ineligible for high-dose chemotherapy supported with autologous stem-cell transplantation at the time of initiation of induction therapy; Patients refusing to receive the high-dose chemotherapy. 4. Patients aged 20-year-old or above (At the time of registration) 5. Female patients who are not pregnant or may not become pregnant. 6. Patients accepting contraception by appropriate method during the therapy. 7. Patients without any history of hypersensitivity against bortezomib, mannnitol or boron. 8. Patients with ECOG Performance Status of 0 to 2 9. Patients without a serious and active infectious disease 10. Patients with sufficient major organ function (except the obstacles due to myeloma) for evaluating the safety and efficiency: Meeting all of the following criteria. a. Neutorophil counts of 750/micro litter or above b. Platelet counts of 50000/micro litter or above c. PaO2 of 60mmHg or above; SaO2 of 93% or above d. No grade 1 peripheral neuropathy with neuropathic pain; no peripheral neuropathy of Grade 2 or more e. Serum AST/ALT values of 3 times of the upper limit of the standard values in each institute or below f. Serum total bilirubin values of 2 times of the upper limit of the standard values in each institute or below g. LVEF of 50% or above 11. Patients who have been fully explained about the purpose and the procedures of the study by the provided Informed Consent Form and have agreed to participate the study from their own will.
Exclusion criteria
Exclusion criteria: 1. Patients with psychiatric disorders or psychological symptoms that are seemed to provide some difficulties for their participation. 2. Patients with a history of pretreatment for myeloma 3. Patients having a serious active infection 4. Patients in whom some signs of interstitial pneumonia present or are suspected in their chest-imaging exams. 5. Patients who have or may have serious pulmonary dysfunction. 6. Patients who have or may have serious cardiac dysfunction. 7. Patients with serum AST/ALT values of greater than 3 times of the upper limit of the standard values in each institute. 8. Patients with serum total bilirubin values of greater than 2 times of the upper limit of the standard values in each institute. 9. Patient with some serious drug-hypersensitivity. 10. Patients who cannot make decisions by themselves 11. Patients who are considered as inappropriate for the registration by attending doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate after 5 cycles of consolidation phase of this protocol (Maximum therapeutic results will be judged according to the International Myeloma Working Group Criteria.) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete remission rate after 9 cycles of consolidation phase of this protocol (Maximum therapeutic results will be judged according to the International Myeloma Working Group Criteria.) 2. Frequency and degree of adverse events 3. Completion rate of the protocol; Duration of the therapy (including maintenance-period) 4. Time to progression 5. Time to death 6. Cumulative dose and relative-dose-intensity of administered bortezomib | — |
Countries
Japan
Contacts
Public ContactDaisuke Haraga
Tonoyaka Municipal Hospital the General Affairs Department
Outcome results
None listed