Multiple myeloma
Conditions
Interventions
-Induction with Bortezomib/Lenalidomide/Dexamethasone (VRd) for 6 courses. (Bor 1.3 mg/m2 d1,8,15, Len 25 mg/body d1-21, Dex 20 mg/body d1,2,8,9,15,16,22,23) q28days -Peripheral blood stem cell har
Sponsors
Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Multiple myeloma patients diagnosed with IMWG criteria (2014). 2) Patients with measurable disease. 3) Laboratory data. Neutrophil > 1000/mm3 Hb > 8.0g/dL Platelet > 75000/mm3 T-Bil < 1.5x UNL AST, ALT < 3x UNL Ccr > 30mL/min 4) Performance Status: 0-2
Exclusion criteria
Exclusion criteria: 1) Smoldering or IgM myeloma, solitary plasmacytoma, plasma cell leukemia, POEMS syndrome, WM 2) CNS involvement 3) HIV+, HBs Ag+, or HCV Ab+ 4) Severe abnormality in the liver, kidney, cardiac, or pulmonary functions. Severe diabetes, hypertension, or infection. 5) Severe psychotic disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of autologous peripheral blood stem cell harvest | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) CR after autologous transplantation 2) Response rate after induction therapy 3) Flow MRD negative after autologous transplantation 4) Number of harvested stem cells 5) Flow MRD negative in the collected stem cells bags 6) Adverse events | — |
Countries
Japan
Contacts
Public ContactSatoshi Yoshihara
Hyogo College of Medicine Department of Transfusion Medicine and Cellular Therapy
Outcome results
None listed