Newly-diagnosed multiple myeloma
Conditions
Interventions
1) VRd (bortezomib 1.3mg/m^2 day1,4,8,11, lenalidomide 25 mg day1-14, dexamethasone 20mg day1,2,4,5,8,9,11,12, 21-days cycle, 4 cycles) 2) PBSCH by 4g/m^2-cyclophosphamide combined with G-SCF of G-CS
Sponsors
Tokyo-Kita Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Newly-diagnosed multiple myeloma (2014 IMWG criteria) 2) ECOG performance status 0-2 3) Reserved organ functions a) T.Bil </= 1.5 X WNL, and AST/ALT </= 2.5 X WNL b) ejection fraction >/= 50% c) SaO2 >/= 93% 4) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients who are allergic to drugs used by this protocol study 2) Patients with severe cardiac dysfunction 3) Patients with active and uncontrolled infections 4) Patients with HBs antigen (+) or HCV antibody (+). 5) Patients with uncontrolled malignancies 6) Pregnant women, women who could be pregnant or women who is breast feeding 7) Patients with uncontrolled gastric ulcer 8) Past history of renal transplantation 9) Past history of pulmonary embolism, cardiac infarction and/or brain infarction 10) Patients with uncontrolled diabetes 11) severe psychiatric disorders 12) Patients with other inadequate conditions determined by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate after KRd consolidation therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Overall survival rate 2.Progression-free survival rate 3.Response rates after each regimes 4.Best response rate 5.Number of CD34 positive cell yield by PBSCH 6.Adverse events of each regimens | — |
Countries
Japan
Contacts
Public ContactAkira Tanimura
Tokyo-Kita Medical Center Department of Hematology
Outcome results
None listed