UMIN-CTR Clinical Trial

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

Multiple myeloma.

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japanese Society of Myeloma

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

08

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2009

Year

08

Month

03

Day

Last modified on

2018

Year

08

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002794