UMIN-CTR Clinical Trial

Basic information
Public title	Randomized phase II study of bortezomib plus dexamethasone (BD) versus thalidomide plus dexamethasone (TD) for relapsed or refractory multiple myeloma (JCOG0904, r II BD vs TD for MM)
Acronym	Randomized phase II study of bortezomib plus dexamethasone (BD) versus thalidomide plus dexamethasone (TD) for relapsed or refractory multiple myeloma (JCOG0904, r II BD vs TD for MM)
Scientific Title	Randomized phase II study of bortezomib plus dexamethasone (BD) versus thalidomide plus dexamethasone (TD) for relapsed or refractory multiple myeloma (JCOG0904, r II BD vs TD for MM)
Scientific Title:Acronym	Randomized phase II study of bortezomib plus dexamethasone (BD) versus thalidomide plus dexamethasone (TD) for relapsed or refractory multiple myeloma (JCOG0904, r II BD vs TD for MM)
Region	Japan

Condition
Condition	bortezomib- and thalidomide-naïve relapsed or refractory multiple myeloma after one or more prior lines of chemotherapy
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this trial is to compare bortezomib plus dexamethasone (BD) with thalidomide plus dexamethasone (TD) for selecting more effective secondline treatment based on 1-year progression free survival rates.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	1-year progression free survival rate
Key secondary outcomes	adverse events, serious adverse events, best response rate, progression free survival, overall survival

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	A: bortezomib (1.3mg/m2, days 1,4,8,11) and dexamethasone (20mg/day, days 1,2,4,5,8,9,11,12 for cycles 1-2, days 1,2,4,5 for cycles 3-8 ) administered for eight 21-day cycles as induction therapy, followed by bortezomib (1.3mg/m2, days 1,8,15,22) and dexamethasone (20mg/day, days 1,2,3,4) administered for 35-day cycles as maintenance therapy
Interventions/Control_2	B: thalidomide (100mg/day then increased to 200mg/day, days 1 to 21) and dexamethasone (20mg/day, days 1 to 4, 8 to11 for cycles 1-2, days 1 to 4 for cycles 3-8) administered for eight 21-day cycles as induction therapy, followed by thalidomide (200mg/day, days 1 to 35) and dexamethasone (20mg/day, days 1 to 4) administered for 35-day cycles as maintenance therapy
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 before initial treatment 2) relapsed and/or refractory cases after at least one prior chemotherapy 3) Aged 20 to 79 years old 4) either menopausal women aged at 50 or older, women after hysterectomy, or women after bilateral ovariectomy 5) men who agreed to use contraception 6) performance status: 0-2, or 3 due to osteolytic lesions alone 7) having measurable paraprotein defined as serum monoclonal immunoglobulin concentration of at least 1.0g/dL of IgG, or at least 0.5g/dL of absolute serum concentration of IgA/IgD, or urinary excretion of at least 0.2g of paraprotein per 24 hours in spite of the type of myeloma 8) having no prior treatment with bortezomib and that with thalidomide 9) at least 22 days have passed after the prior therapy 10) having neither of the following complications: plasma cell leukemia, cardiac amyloidosis, gastrointestinal amyloidosis 11) having no current complications of deep vein thrombosis or pulmonary embolism 12) not received allogeneic hematopoietic stem cell transplantation 13) absolute neutrophil count: no less than 1,200/mm3, platelet count: no less than 60,000/mm3, hemoglobin concentration: at least 7.0 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, corrected serum calcium: 12.5 mg/dL or below, serum sodium: 130 mEq/L or above, PaO2 (room air): at least 70 torr, serum FDP: 10 ug/dL or below, ECG: neither ischemic change nor arrhythmia reqiuring medical intervention, cardiac ejection fraction: at least 50% 14) written informed consent by the patient
Key exclusion criteria	1) synchronous or metachronous malignancy 2) active infection 3) febrile over 38oC 4) pregnant or nursing women 5) psychological disturbance 6) continued treatment with steroids for non-malignant disorders 7) insulin-dependent or uncontrollable diabetes mellitus 8) uncontrollable hypertension 9) HBs-Ag positive or HCV-Ab positive 10) HIV-Ab positive 11) interstitial pneoumonia, pulmonary fibrosis, severe pulmonary edema, or severe pleural effusion on chest CT 12) grade 2 or higher peripheral neuropathy, or grade 1 or higher neuralgia 13) glaucoma 14) allergic history to borate or mannitol
Target sample size	44

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinsuke Iida
Organization	Nagoya City University Hospital
Division name	Department of Hematology and Oncology
Zip code
Address	1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL	052-853-8738
Email	iida@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shinsuke Iida
Organization	JCOG0904 Coordinating Office
Division name	Department of Hematology and Oncology, Nagoya City University Hospital
Zip code
Address	1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL	052-853-8738
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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

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） 岡山医療センター（岡山県） 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） 国立病院機構九州医療センター（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） 琉球大学医学部附属病院（沖縄県）

Other administrative information
Date of disclosure of the study information	2010 Year 02 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	2010 Year 01 Month 18 Day
Date of IRB	2010 Year 01 Month 26 Day
Anticipated trial start date	2010 Year 02 Month 03 Day
Last follow-up date	2018 Year 02 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 02 Month 03 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=R000003741