UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The evaluation of the efficacy and safety on Bortezomib and Dexamethasone (BD therapy) using auto-PBSCT treatment after Vincristine,Doxorubicin and examethasone (VAD treatment) registanced multiple myeloma patients.(JMSG-0901)
Title of the study (Brief title)	Evolution of efficacy and safety on high-dose-chemotherapy using auto-PBSCT for symptomatic multiple myeloma.(JMSG-0901)
Region	Japan

Condition
Condition	Multiple myeloma.
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The study of efficacy and safety on Bortezomib and Dexamethasone (BD therapy)during 2-4course continually auto-PBSCT treatment for the poor response of induction chemotherapy less than VGPR after treatment of standard remission induction chemotherapy, incristine, Doxorubicin and Dexamethasone during 2 weeks periods (short VA) for non-treatment multiple myeloma patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The ratio of complete remission (SCR, CR) after 100 days auto-PBSCT treatment.
Key secondary outcomes	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.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	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 executed by 2-4 courses. 3) Auto peripheral blood stem cell transplant.(Auto-PBSCT)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key 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.
Key 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.
Target sample size	40

Research contact person
Name of lead principal investigator	Takashi Yoshida
Organization	Shizuoka City Shimizu Hospital
Division name	Department of Hematology
Address	1231 Miyakami, Shizuokashi, shimizu-ku, Shizuoka-ken JAPAN
TEL	054-336-1111
Email	tyoshida@mua.biglobe.ne.jp

Public contact
Name of contact person	Takashi Yoshida
Organization	Shizuoka City Shimizu Hospital
Division name	Department of Hematology
Address	1231 Miyakami, Shizuokashi, shimizu-ku, Shizuoka-ken JAPAN
TEL	054-336-1111
Homepage URL	http://www.jsm.gr.jp/kenkyu.html
Email	tyoshida@mua.biglobe.ne.jp

Sponsor
Institute	Japanese Society of Myeloma
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2009 Year 08 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 04 Month 07 Day
Anticipated trial start date	2009 Year 05 Month 01 Day
Last follow-up date	2014 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 08 Month 03 Day
Last modified on	2018 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002794