untreated multiple myeloma
Conditions
Interventions
VCD bortezomib 1.3mg/m2 (iv or sc) on days 1,8,15 and 22 cyclophosphamide 300mg/m2 (po) on days 1,8,15 and 22 dexamethasone 20mg/body (po) on days 1,2,8,9,15,16,22 and 23 VCD treatment is repeate
Sponsors
Kanagawa Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. multiple myeloma defined by IMWG criteria 2.untreated multiple myeloma 3.existence of measurable disease 4. aged >=20 and =<65 5. PS(ECOG) 0-2 6. The following standards are filled 1 )the neutrophil counts >= 1,000/mm3 2) the platelet counts >= 75,000/mm3 3) AST <= 2.5 times of a facilities standard value 4) ALT <= 2.5 times of a facilities standard value 5)T-bil <= 1.5 times of a facilities standard value 6)Cr <= 2.5 mg/dl 7)ischemic change, atrial fibrillation and ventricular arrhythmia to need treatment is neither found in echocardiography. 8) LV Ejection Fraction >= 50% 9)SpO2 >= 94% 10)Neither interstitial pneumonitis, pulmonary fibrosis, emphysema nor plueral effusion is recognized by computed tomography. 7. agree to contraception 8. voluntary written informed consent
Exclusion criteria
Exclusion criteria: 1. severe renal damage: Ccr <30mL/min even after correction of dehydration and hypercalcemia 2.severe cardiac dysfunction: angina pectoris or acute myocardial infarction within 6 months of enrollment, congestive heart failure requiring medical treatment or arrhythmia requiring medical treatment. 3.severe respiratory dysfunction: SpO2 <= 93%, interstitial pneumonitis, chronic obstructive pulmonary disease, active pneumonia 4.infection 4-1HIV positive 4-2HBs antigen positive 4-3HBs antibody positive and/or HBc antibody positive and HBV-DNA positive 4-4HCV antibody positive 5.peripheral neuropathy > grade 2 6.Uncontrolled diabetes mellitus 7.others 7-1active double cancer 7-2pregnancy or breastfeeding 7-3doctor judged adequate to enroll the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sCR,CR and VGPR rate after 4 cycles of VCD treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)overall response rate (sCR,CR,VGPR and PR) after 4 cycles of VCD 2)complete response rate (sCR and CR) after 4 cycles of VCD 3)completion rate of 4 cycles of VCD 4)total number of PBSC after PBSCH 5)completion rate of ASCT 6)complete response rate at 100 days after ASCT 7)incidence of adverse events 8)progression free survival duration 9)overall survival duration | — |
Countries
Japan
Contacts
Public ContactYukako Hattori
Kanagawa Cancer Center Department of Medical Oncology
Outcome results
None listed