UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000011563
Receipt number	R000013528
Scientific Title	BoRtezomib-based Optimized therapy Aiming Disease control in Japan 2
Date of disclosure of the study information	2013/09/01
Last modified on	2018/10/15 10:43:31

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Basic information

Public title

BoRtezomib-based Optimized therapy
Aiming Disease control in Japan 2

Acronym

BoRtezomib-based Optimized therapy
Aiming Disease control in Japan 2:BROAD-J 2 study

Scientific Title

BoRtezomib-based Optimized therapy
Aiming Disease control in Japan 2

Scientific Title:Acronym

BoRtezomib-based Optimized therapy
Aiming Disease control in Japan 2:BROAD-J 2 study

Region

Japan

Condition

Multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To investigate the efficacy, safety and the time to treatment failure of Bortezomib subcutaneous administration as induction and maintenance therapy for untreated multiple myeloma patients ineligible for autologous stem cell transplantation

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Incidents of adverse events

Key secondary outcomes

Best response rate,Time to progression

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

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Bortezomib(1.3m/m2,days 1,8,15,22, sq),Melphalan(6mg/m2,days 1-4) and prednisone(40mg/m2,days 1-4) administered for four 35-day cycles as induction therapy,followed by Bortezomib(1.3mg/m2,day1,15, sq) administered for 28-day cycles until relapse as maintenance therapy.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)symptomatic multiple myeloma diagnosed by the criteria of international Myeloma Working Group (IMWG)
(2)untreated patients without a history of pretreatment, excluding local radiotherapy from pretreatment
(3)untreated multiple myeloma patients who diagnosed ineligible for autologous stem cell transplantation at induction therapy
(4)aged more than 20 years old
(5)performance status:0-2,or 3 due to osteolytic lesions alone
(6)coexisting conditions are eligible as follows:
neutrophil count; more than 1,000/mm3,platelet count; more than 50,000/mm3,hemoglobin count; more than 7.0g/dL
(7)Menopausal patients who have had the last menstruation one year or more before and have an intention to prevent conception during the study by contraceptive operation or other appropriate method (a contraceptive or a contraceptive device) or male patients who agree to contraception by contraceptive operation or other appropriate method
(8)Patients who have given consent to participate in the study of their own free will after having received from the principal investigator or subinvestigator (and the study collaborator) full information about the purpose and procedure of the study using the Informed Consent Form and Patient Information.

Key exclusion criteria

(1)Patients with a past history of allergy to the drug described in the protocol
(2)Patients who have had a complication of active double cancer* within the past 5 years * Excluding basal cell carcinoma of the skin, squamous cell carcinoma, epithelial carcinoma in situ considered to have been cured by topical treatment or lesions corresponding to intramucosal carcinoma (excluding cervical carcinoma presenting in FIGO Stage I)
(3)HBs antigen,or HCV antibody positive patients
(4) serious mental disorders such as schizophrenia
(5) Patients with a clinical picture of pneumonia (interstitial pneumonia) or fibroid lung or an abnormal bilateral interstitial abnormality on X-ray scan regardless of the presence or absence of symptoms
(6) Patients who have or suspected of having a serious active infection
(7) Patients with serious pulmonary dysfunction
(8) Patients who have serious cardiac dysfunction or present with ECG or a chest diagnostic image that indicates treatment
(9)The serum AST value and ALT value is more than 2.5 times from a facilities upper limit
(10)The serum total bilirubin value is more than 2.0 times from a facilities upper limit
(11)Patients with grade 2 or severer peripheral neuropathy
(12)Women who are or may be pregnant
(13)Other patients who are,in the opinion of the caring investigator, unfit for enrollment in the study

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Masahiro Kizaki

Organization

Saitama Medical Center,Saitama Medical University

Division name

Department of Hematology

Zip code

Address

1981,Kamoda,Kawagoe-shi,Saitama,

TEL

049-228-3471

Email

info@broadj.org

Public contact

Name of contact person

1st name

Middle name

Last name Kenshi Suzuki

Organization

Japanese Red Cross Medical Center

Division name

Department of Hematology

Zip code

Address

4-1-22,Hiroo,Shibuya-ku,Tokyo,

TEL

03-3400-1311

Homepage URL

http://broadj.org

Email

info2@broadj.org

Sponsor or person

Institute

Saitama Medical Center, Saitama Medical University

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 01 Day

Related information

URL releasing protocol

http://broadj.org/pass/protocol-j2.html

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

2013 Year 07 Month 01 Day

Date of IRB

Anticipated trial start date

2013 Year 07 Month 01 Day

Last follow-up date

2018 Year 06 Month 30 Day

Date of closure to data entry

2018 Year 06 Month 30 Day

Date trial data considered complete

2018 Year 06 Month 30 Day

Date analysis concluded

2018 Year 12 Month 31 Day

Other

Other related information

Management information

Registered date

2013 Year 08 Month 23 Day

Last modified on

2018 Year 10 Month 15 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013528

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name