Multiple myeloma.
Conditions
Interventions
1) The standard remission introduction treatment (Vincristine, Doxorubicin, and Dexamethasone (short VAD treatment) is executed by two courses. 2) Bortezomib and Dexamethasone (BD) treatment is execu
Sponsors
Japanese Society of Myeloma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient to whom it was confirmed that it was symptom (symptomatic) myeloma multiplex by diagnostic norm of International Myeloma Working Group(IMWG).(reference1) 2) Patient who can measure M protein that becomes index of therapy evaluation in serum or urine. 3) Case that general state is excellent (Performance Status; PS is 0-2)(reference 2). The PS deterioration by the osteolytic lesion is excluded. 4) Registration is less than 65 years old from 20 years over. 5) The function of the key organ is kept, and the following standards are filled. 1. The neutrophil counts is 1,500/micro liter or more. 2. The platelet is 75,000/micro liter or more. 3. The serum total bilirubin value is Less than three times a facilities standard value. 4. The serum AST , ALT value is Less than three times a facilities standard value. 5. The serum creatinine value is Less than three times a facilities standard value. 6. Ejection Fraction is 50 percent or more. 7. PaO2 is an arterial blood liquid gas analysis, is 60mmHg or more or a transdermal oxygen saturation level meter, and SaO2 is 93 percent or more. 6) The living for three months or more can be expected. 7) There is an intention to which it practices birth control while examining it after climacteric (patient who passes from the last menses one year or more) by surgical contraception or an appropriate method (birth-control pill and contraceptive etc.) for the female patient. 8) It agrees to contraception by the proper procedure for the male patient while examining it. The patient who has received the notification uses the agreement document and other explanation books on prescribed on the content of the examination from the examination responsibility doctor or the examination allotment doctor, the explanation is received enough, and agreement is obtained by the free will with the document to the examination participation.
Exclusion criteria
Exclusion criteria: 1) There is a previous history of hypersensitivity for, Bortezomib the Doxorubicin, the Dexamethasone, the mannitol or boron. 2) Myeloma and plasma cell leukemia of nonsecreted form. 3) Case from whom amalgamation of nuclear power plant AL amyloidosis is doubted. 4) Case who has peripheral neuropathy of Grade 2 or more. 5) Patient of HIV antibody positivity, hepatitis B surface antigen positivity, and HCV antibody positivity. 6) There are a defective liver dysfunction to control, a renal dysfunction, a depressed ventricular function, a pulmonic impairment, a diabetic, high blood pressure, and an infectious disease. 7) It is briskness and a double cancer of the progress period (Simultaneity repetition cancer and a healthy period are the cancer of repetition of different time within five years. However, the considerable Carcinoma in Situ change to a morbid state in the neck of womb, the stomach, and the large intestine judged to be a recovery by the limited part treatment is not included in the double cancer of briskness). 8) A certain patient of serious illness such as schizophrenia. mental trouble. 9) Case pregnant woman and possibility getting pregnant and suckling during examination period. 10) The case (Consult if necessary with a special doctor such as respiratory organs) who admits an abnormal shadow of the quality (state of frosted glass and line shadow) among both sides on chest CT (high resolution CT) regardless of the presence of the case who has the lungs flame (interstitial pneumonia) and the pulmonary fibrosis in the clinical finding or the symptom. 11) Additionally, case who judged doctor in charge targets and it is improper.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of complete remission (SCR, CR) after 100 days auto-PBSCT treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. complete remission ratio after BD treatment (CR or PR). 2. All taking effect ratio after 100 days of private blood formation stem cell transplant (Auto PBSCT) (CR and PR). 3. Periods of progression free survival. (PFS) 4. Overall survival for 3 years. (3y OS) 5. Safety. | — |
Countries
Japan
Contacts
Public ContactTakashi Yoshida
Shizuoka City Shimizu Hospital Department of Hematology
Outcome results
None listed