Multiple myloma
Conditions
Interventions
Dose of Bortezomib
Sponsors
Division of Hematology, Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with multiple myeloma who receive first auto PBSCT at Keio university hospital 2) Patients who received PBSCC with high dose CY plus G-CSF 3) Patients who have not receive any chemotherapy without high dose CY whithin 30 days before SCT 4) Patients able to give written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with abnormalities with liver function: AST >2.5X ULN, ALT >2.5X ULN, T-Bil >2X ULN(except for disease activity) 2) Patients with abnormalities with renal function: CRTNN >2.0 mg/dl 3)Patients with abnormalities in cardiac function or pulmonary function: EF <50%(assessed on cardiac ultrasonography) , %VC <75% 4)Patients with organ dysfunction due to amyloidosis 5)Patients unable to differentiated from primary amyloidosis or POEMS syndrome 6)Patients with previous serious allergy to Bortezomib, Melphalan or dexamethasone 7)Patients with grade 2 or greater neuropathy due to Bortezomib 8)Patients with active infection 9) Patients with active viral hepatitis or HBs-Ag positive 10)Patients with serious or uncontrolled medical condition such as uncontrolled diabetes, uncontrolled active infection, significant cerebrovascular disease or poorly controlled psychiatric disease 11) Others: Inappropriate patients determined by a principal investigator or sub-investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety untill day 28 after SCT | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate and Improvement rate of overall response at day 100 after SCT | — |
Countries
Japan
Contacts
Public ContactHidenori Kasahara
Keio University School of Medicine Division of Hematology
Outcome results
None listed