multiple myeloma
Conditions
Interventions
1) 4 courses of CyBorD therapy(cyclophosphamide, bortezomib, and dexamethasone) 2) If not reached VGPR by CyBorD therapy, add lenalidomide and dexamethasone therapy, maximum 4 courses 3) Periheral b
Sponsors
Division of Hematology, Saitama Medical Center, Jichi Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with symptomatic multiple myeloma 2) Patients who have never received therapy for myeloma, excluding local radiation therapy 3) Patients with measurable disease (Serum M-protein >= 1g/dL, Urinary M-protein >=200mg/day, or tumor derived-FLC(iFLC)>100mg/L) 4) Performance Status being 0-2. Patients with Performance Status of 3 due to bone lesion are permitted 5) Patients who have the following laboratory values within 14 days before enrollment 1. SpO2 >= 94% 2. neutrophil count >= 1000/mm3 3. platelet count >= 75000/mm3 4. Patients who do not require hemodialysis 5. serum total bilirubin <= 1.5 x upper limit of normal 6. ALT <= 2.5 x upper limit of normal 7. AST <= 2.5 x upper limit of normal 7) Patients who agreed to contraception by an appropriate method 8) Written informed concent has been obtained
Exclusion criteria
Exclusion criteria: 1) Patients with a history of allergy to the drugs used in the protocol therapy 2) Patients who can not be expected to survive more than 3 months 3) Patients who suffered another carcinoma within 5 years 4) Patients with HBs antigen-positive, or HCV antibody-positive, or HIV antibody-positive 5) Patients who have peripheral neuropathy or peripheral neuropathic pain of grade 2 or more. 6) Patients with serious active infection or patients who are suspected to have serious active infection infections 7) Patients with serious mental disorders 8) Patients with serious pulmonary dysfunction 9) Patients with interstitial pneumonia or pulmonary fibrosis 10) Patients with serious heart dysfunction 11) Patients with poorly controlled diabetes 12) Patients receiving hemodialysis 13) Patient who are or may be pregnant or are nursing 14) Patients who are determined to be inappropriate for study by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR rate at day 100 from autologous transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) overall response rate 2) treatment completion rate 3) 3-year progression free survival 4) 3-year overall survival 5) safety | — |
Countries
Japan
Contacts
Public ContactGo Yamamoto
Toranomon Hospital Department of Hematology
Outcome results
None listed