UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000011180
Receipt No. 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 (Ver. 6)

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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 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)
Scientific Title: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)
Region
Japan

Condition
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 NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
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 90

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
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

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
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
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 91
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 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
Adverse events 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
Outcome measures 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
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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013023