UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003135 |
|---|---|
| Receipt number | R000003741 |
| 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) |
| Date of disclosure of the study information | 2010/02/03 |
| Last modified on | 2022/08/30 16:51:08 |
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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
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/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group(JCOG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003741
