Newly diagnosed multiple myeloma
Conditions
Interventions
Induction therapy Cyclophosphamide 300mg/m2 on days 1,8,15 and 22,orally Bortezomib 1.3mg/m2 on days 1,8,15 and 22,subcutaneous injection Dexamethasone 40mg/body on days 1,8,15 and 22,orally 4
Sponsors
Ochanomizu blood study committee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.multiple myeloma defined by IMWG criteria. 2.stage II-III of Durie and Slamon classification. 3.aged >15 and <65. 4.PS(ECOG)0-2.(Patients with poor P.S. by bone pain accompanying myeloma can be included.) 5.Main organ function is maintained a.liver function:T-bil,AST and ALT < 2 times upper limit of normal standard b.bone marrow function:Absolute neutrophil counts >1000/mm3,Platelet counts>100,000/mm3(Platelet transfusion before treatments is excluded),Hemoglobin>8.0g/dl(RCC transfusion before treatments is included) c.cardiac function:EF >50% d.pulmonary function:SaO2 >93% e.renal function:Serum Creatinine <4mg/dl 6.No previous anti-myeloma therapy(Systemic steroid hormone is included).Bisphosphonate and denosumab are allowed. 7.voluntary written informed consent
Exclusion criteria
Exclusion criteria: 1)History of allergic reactions to drugs contained in the protocol 2)Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 4 3)Uncontrolled or severe cardiovascular disease, including AMI within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, or cardiac amyloidosis 4)Acute severe infection requiring antibiotic therapy 5)HBs antigen,HCV antibody positive 6)Previous cancer history (except in situ carcinoma of cervix or basal cell cancer of skin) 7)Pregnancy or breastfeeding 8)Active ulcer detected by gastroscopy (gastroscopy is not routine in all patients, only to patients with symptoms of ulcer disease and/or history of previous ulcer therapy and/or physician's discretion) 9)Previous renal transplantation 10)Recurrent deep vein thrombosis or pulmonary embolism 11)Uncontrolled diabetes mellitus 12)Severe psychiatric disorders 13)Those who are considerd as inappropriate to register by attending physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CR/nCR rate after CBD therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)SCR,CR,nCR,VGPR and PR rate after CBD therapy 2)Overall survival(OS) 3)Progression free survival(PFS) 4)Duration of response 5)Incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactDaisuke Kudo
Hitachi General Hospital Division of Hematology
Outcome results
None listed