UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000011180
Receipt number	R000013023
Scientific Title	Randomized phase II study of two induction treatments of melphalan, prednisolone, plus bortezomib, JCOG-MPB versus modified PETHEMA-MPB, in elderly patients or non-elderly patients refusing transplant with untreated symptomatic myeloma(JCOG1105, IMPROVE-MPB study)
Date of disclosure of the study information	2013/07/12
Last modified on	2022/08/30 17:18:13

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Basic information

Public title

Randomized phase II study of two induction treatments of melphalan, prednisolone, plus
bortezomib, JCOG-MPB versus modified PETHEMA-MPB, in elderly patients or non-elderly patients refusing transplant with untreated symptomatic myeloma(JCOG1105, IMPROVE-MPB study)

Acronym

Randomized phase II study of two induction treatments, JCOG-MPB versus modified PETHEMA-MPB, in elderly patients or non-elderly patients refusing transplant with untreated symptomatic myeloma(JCOG1105, IMPROVE-MPB study)

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Elderly patients or non-elderly patients refusing transplant with untreated symptomatic myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

Objectives

Narrative objectives1

The objective of this trial is to compare complete response rate of modified PETHEMA-melphalan+prednisolone+bortezomib (MPB) with that of JCOG-MPB for selecting more effective induction regimen in elderly patients or non-elderly patients refusing transplant with untreated symptomatic myeloma.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Assessment

Primary outcomes

Complete response rate

Key secondary outcomes

proportion of treatment completion, overall response rate, stringent complete response rate, overall survival, progression-free survival, time to next treatment, adverse events, serious adverse events, efficacy according to chromosomal translocation-associated protooncogene expression

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

Concealment

Central registration

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Arm A: modified PETHEMA-MPB therapy consists of nine cycles: one cycle of subcutaneous or intravenous bortezomib given twice per week for 6 weeks (1.3 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32), plus oral melphalan 9 mg/m2 and oral prednisolone 60 mg/m2 on days 1-4, followed by eight cycles of subcutaneous or intravenous bortezomib once per week for 5 weeks (1.3 mg/m2 on days 1, 8, 15, and 22) plus the same doses of oral melphalan and prednisolone.

Interventions/Control_2

Arm B: JCOG-MPB therapy consists of nine cycles of subcutaneous or intravenous bortezomib give once per week for 4 weeks (1.3 mg/m2 on days 1, 8 and 15), plus oral melphalan 7 mg/m2 and oral prednisolone 60 mg/m2 on days 1-4.

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

79 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Diagnosed as having symptomatic multiple myeloma
2) Aged 65 to 79 years old, or 20 to 64 years old who refused high-dose therapy followed by autologous stem-cell transplantation
3) Untreated for multiple myeloma
4) Having measurable paraprotein defined as serum monoclonal immunoglobulin concentration of at least 1.0 g/dL of IgG, or at least 0.5 g/dL of absolute serum concentration of IgA/IgD, or urinary excretion of at least 0.2 g of paraprotein per 24 hours regardless of the type of myeloma
5) Not having plasma cell leukemia
6) Having neither of cardiac amyloidosis nor gastrointestinal amyloidosis
7) Performance status: 0-2, or 3 due to osteolytic lesions alone
8) Absolute neutrophil count: no less than 1,000/mm3, platelet count: no less than 75,000/mm3, hemoglobin concentration: at least 8.0 g/dL, AST/ALT: no more than 100IU/L, total bilirubin: 1.8 mg/dL or below, serum creatinene: 2.5 mg/dL or below, PaO2 (room air) at least 70 torr, ECG: neither ischemic change nor arrhythmia requiring medical intervention, cardiac ejection fraction: at least 50%
9) Peripheral neuropathy of grade 1 or less and no neuralgia
10) Written informed consent by the patient including contraception

Key exclusion criteria

1) Synchronous or metachronous malignancy
2) Active infection
3) Pregnant or nursing women
4) Psychiatric disease
5) Continuous systemic treatment with steroids for non-malignant disorders
6) Insulin-dependent or uncontrollable diabetes mellitus
7) Uncontrollable hypertension
8) HBs-Ag positive or HCV-Ab positive
9) HIV-Ab positive
10) Interstitial pneoumonia, pulmonary fibrosis, severe pulmonary emphysema, or severe pleural effusion on chest CT
11) Uncontrollable Glaucoma
12) Allergic history to borate or mannitol

Target sample size

Research contact person

Name of lead principal investigator

1st name Iida

Middle name

Last name Shinsuke

Organization

Nagoya City University Hospital

Division name

Division of Hematology & Collagen Diseases

Zip code

467-8601

Address

1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan

TEL

052-851-5511

Email

iida@med.nagoya-cu.ac.jp

Public contact

Name of contact person

1st name Dai

Middle name

Last name Maruyama

Organization

JCOG1105 Coordinating Office

Division name

Department of Hematology, National Cancer Center Hospital

Zip code

104-0045

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.

TEL

03-3542-2511

Homepage URL

http://www.jcog.jp/

Email

JCOG_sir@ml.jcog.jp

Sponsor or person

Institute

Japan Clinical Oncology Group (JCOG)

Institute

Department

Personal name

Funding Source

Organization

National Cancer Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

National Cancer Center Institutional Review Board

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

Tel

03-3542-2511

Email

NCC_IRBoffice@ml.res.ncc.go.jp

Secondary IDs

YES

Study ID_1

jRCTs031180097

Org. issuing International ID_1

jRCT

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立病院機構北海道がんセンター（北海道）
札幌北楡病院（北海道）
東北大学病院（宮城県）
秋田大学医学部（秋田県）
太田西ノ内病院（福島県）
群馬大学医学部附属病院（群馬県）
埼玉県立がんセンター（埼玉県）
埼玉医科大学総合医療センター（埼玉県）
国立がん研究センター東病院（千葉県）
千葉県がんセンター（千葉県）
国立がん研究センター中央病院（東京都）
杏林大学医学部（東京都）
東京医科大学病院（東京都）
東京慈恵会医科大学附属病院（東京都）
東京慈恵会医科大学第三病院（東京都）
がん研究会有明病院（東京都）
NTT東日本関東病院（東京都）
東海大学医学部（神奈川県）
金沢医科大学（石川県）
福井大学医学部附属病院（福井県）
浜松医科大学（静岡県）
愛知県がんセンター中央病院（愛知県）
国立病院機構名古屋医療センター（愛知県）
名古屋大学医学部（愛知県）
名古屋市立大学病院（愛知県）
名古屋第二赤十字病院（愛知県）
愛知医科大学附属病院（愛知県）
三重大学医学部（三重県）
滋賀県立成人病センター（滋賀県）
京都府立医科大学（京都府）
兵庫県立がんセンター（兵庫県）
広島大学病院（広島県）
国立病院機構四国がんセンター（愛媛県）
愛媛大学医学部附属病院（愛媛県）
国立病院機構九州がんセンター（福岡県）
福岡大学医学部（福岡県）
産業医科大学（福岡県）
佐賀大学医学部（佐賀県）
国立病院機構長崎医療センター（長崎県）
佐世保市立総合病院（長崎県）
長崎大学病院（長崎県）
熊本大学医学部（熊本県）
国立病院機構熊本医療センター（熊本県）
大分県立病院（大分県）
鹿児島大学医学部・歯学部附属病院（鹿児島県）
今村病院分院（鹿児島県）

Other administrative information

Date of disclosure of the study information

2013 Year 07 Month 12 Day

Related information

URL releasing protocol

https://jrct.niph.go.jp/latest-detail/jRCTs031180097

Publication of results

Published

Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/32583431/

Number of participants that the trial has enrolled

Results

See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website:
http://www.jcog.jp/en/trials/index.html

Results date posted

2022 Year 08 Month 27 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Please refer to the "JCOG1105 clinical study report" posted on the following website. Or please refer to the following jRCT website.

http://www.jcog.jp/basic/clinicaltrial/index.html
https://jrct.niph.go.jp/latest-detail/jRCTs031180097

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 05 Month 17 Day

Date of IRB

2013 Year 07 Month 09 Day

Anticipated trial start date

2013 Year 07 Month 12 Day

Last follow-up date

2019 Year 01 Month 12 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2013 Year 07 Month 12 Day

Last modified on

2022 Year 08 Month 30 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013023

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name