Multiple myeloma
Conditions
Interventions
Patients received 5 cycles of MPB. MPB included the IV or SQ administration of weekly bortezomib at 1.3 mg/m2 in combination with oral melphalan 6 mg/m2 and prednisone 40 mg/m2 once daily on days 1 -
Sponsors
Japan Myeloma Expert Network (J-MEN) of Japan Myeloma Network (JMN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All the following criteria MUST be met: 1) Age >=20 years old 2) Symptomatic multiple myeloma received NO prior treatment and NO indication for autologous stem cell transplantation 3) Measurable disease: serum IgG, IgA, IgM protein >=0.5 g/dL; IgD >=0.05 g/dL; urinary M-protein excretion 200 mg/24-hour 4) ECOG performance status 0-2 or 3 by bone lesion 5) Preserved organ function: Serum AST or ALT <3 x ULN Creatinine clearance >=30 ml/min Neutrophil >=1000 /mm3 Platelet >=75000 /mm3 Ejection fraction >=50% PaO2 >=60 mmHg or SpO2 >=93% 6) Able to comply RevMate 7) Disease notified 8) Given voluntary written consent for the this trial
Exclusion criteria
Exclusion criteria: 1) Women in pregnancy or lactation 2) plasma cell leukemia, cardiac amyloidosis, POEMS syndrome 3) Peripheral neuropathy Grade >=2 4) Uncontrolled liver dysfunction, renal dysfunction, heart failure, impaired respiratory function, diabetes, or hyper tension 5) Concurrent diseases of tuberculosis, herpes simplex keratitis, systemic fungal disease, or active infection 6) Postcapsular cataract 7) Recent operation history 8) Myocardial infarction in past 6 months or deep vein thrombosis / pulmonary embolism within 3 months 9) Active and advanced cancer (simultaneous or within 5 years after remission) 10) Positive for hepatitis B antigen, hepatitis C antibody, or HIV antibody 11) Concurrent pneumonitis (interstitial pneumonia), lung fibrosis, or abnormal (high-resolution) chest CT findings in both lung with/without symptom 12) The patient judged inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) stringent complete remission rate, 2) complete remission rate, 3) response rate (partial response or better), 4) progression free survival rate at 2 years from the maintenance treatment with lenalidomide, 5) progression free survival rate at 3 years from the maintenance treatment with lenalidomide, 6) progression free survival rate at 2 years from the induction treatment, 7) progression free survival rate at 3 years from the induction treatment, 8) overall survival rate at 2 years from the induction treatment, 9) overall survival rate at 3 years from the induction treatment, 10) frequency of adverse events | — |
Countries
Japan
Contacts
Public ContactYumi Miyashita
Epidemiological and Clinical Research Information Network (ECRIN) Aichi Branch
Outcome results
None listed