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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003741


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name