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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002285
Receipt No. R000002794
Scientific Title 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)
Date of disclosure of the study information 2009/08/03
Last modified on 2018/08/09

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Basic information
Public title 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)
Acronym Evolution of efficacy and safety on high-dose-chemotherapy using auto-PBSCT for symptomatic multiple myeloma.(JMSG-0901)
Scientific Title 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)
Scientific Title:Acronym 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
1st name
Middle name
Last name Takashi Yoshida
Organization Shizuoka City Shimizu Hospital
Division name Department of Hematology
Zip code
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
1st name
Middle name
Last name Takashi Yoshida
Organization Shizuoka City Shimizu Hospital
Division name Department of Hematology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 04 Month 07 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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