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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009700
Receipt No. R000011346
Scientific Title CBD(cyclophohamide,bortezomib,dexamethasone) induction followed by autologous stem cell transplantation for patients with newly diagnosed multiple myeloma
Date of disclosure of the study information 2013/01/07
Last modified on 2018/05/27

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Basic information
Public title CBD(cyclophohamide,bortezomib,dexamethasone) induction followed by autologous stem cell transplantation for patients with newly diagnosed multiple myeloma
Acronym CBD induction and autologous stem cell transplantation for patients with newly diagnosed multiple myeloma
Scientific Title CBD(cyclophohamide,bortezomib,dexamethasone) induction followed by autologous stem cell transplantation for patients with newly diagnosed multiple myeloma
Scientific Title:Acronym CBD induction and autologous stem cell transplantation for patients with newly diagnosed multiple myeloma
Region
Japan

Condition
Condition Newly diagnosed multiple myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of CBD(cyclophosphamide, bortezomib and dexamethasone) following high dose therapy plus ASCT for patients with newly diagnosed multiple myeloma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes CR/nCR rate after CBD therapy
Key secondary outcomes 1)SCR,CR,nCR,VGPR and PR rate after CBD therapy
2)Overall survival(OS)
3)Progression free survival(PFS)
4)Duration of response
5)Incidence of adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Induction therapy
Cyclophosphamide 300mg/m2 on days 1,8,15 and 22,orally
Bortezomib 1.3mg/m2 on days 1,8,15 and 22,subcutaneous injection
Dexamethasone 40mg/body on days 1,8,15 and 22,orally
4 cycles of cyclophosphamide,bortezomib and dexamethasone(CBD) regimen is repeated every 4 weeks.

Stem cell harvest
autologous peripheral stem cell is collected by mobilization with CPA(2g/m2 div d1,2) following G-CSF.

High dose chemotherapy and Autologous stem cell transplantation
L-PAM 200mg/m2 div(d-2),ASCT(d0)
Interventions/Control_2
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
15 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1.multiple myeloma defined by IMWG criteria.
2.stage II-III of Durie and Slamon classification.
3.aged >15 and <65.
4.PS(ECOG)0-2.(Patients with poor P.S. by bone pain accompanying myeloma can be included.)
5.Main organ function is maintained
a.liver function:T-bil,AST and ALT < 2 times upper limit of normal standard
b.bone marrow function:Absolute neutrophil counts >1000/mm3,Platelet counts>100,000/mm3(Platelet transfusion before treatments is excluded),Hemoglobin>8.0g/dl(RCC transfusion before treatments is included)
c.cardiac function:EF >50%
d.pulmonary function:SaO2 >93%
e.renal function:Serum Creatinine <4mg/dl
6.No previous anti-myeloma therapy(Systemic steroid hormone is included).Bisphosphonate and denosumab are allowed.
7.voluntary written informed consent
Key exclusion criteria 1)History of allergic reactions to drugs contained in the protocol
2)Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 4
3)Uncontrolled or severe cardiovascular disease, including AMI within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, or cardiac amyloidosis
4)Acute severe infection requiring antibiotic therapy
5)HBs antigen,HCV antibody positive
6)Previous cancer history (except in situ carcinoma of cervix or basal cell cancer of skin)
7)Pregnancy or breastfeeding
8)Active ulcer detected by gastroscopy (gastroscopy is not routine in all patients, only to patients with symptoms of ulcer disease and/or history of previous ulcer therapy and/or physician's discretion)
9)Previous renal transplantation
10)Recurrent deep vein thrombosis or pulmonary embolism
11)Uncontrolled diabetes mellitus
12)Severe psychiatric disorders
13)Those who are considerd as inappropriate to register by attending physicians
Target sample size 32

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Kojima
Organization Department of Medical Oncology, Ibaraki Prefectural Central Hospital
Division name Assistant Director
Zip code
Address 6528 Koibuchi, Kasama-shi,Ibaraki 309-1793, Japan
TEL 0296-77-1121
Email h-kojima@chubyoin.pref.ibaraki.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Kudo
Organization Hitachi General Hospital
Division name Division of Hematology
Zip code
Address 2-1-1 Jonan-cho,Hitachi 317-0077,Japan
TEL 0294-23-1111
Homepage URL
Email daisuke.kudo.dv@hitachi.com

Sponsor
Institute Ochanomizu blood study committee
Institute
Department

Funding Source
Organization NPO Ibaraki blood, tumor, palliative care study committee
Organization
Division
Category of Funding Organization Self funding
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 がん・感染症センター都立駒込病院(東京都)、(株)日立製作所日立総合病院(茨城県)、東京医科歯科大学(東京都)、水戸医療センター(茨城県)、茨城県立中央病院(茨城県)、埼玉医科大学(埼玉県)、埼玉医科大学国際医療センター(埼玉県)、都立墨東病院(東京都)、武蔵野赤十字病院(東京都)、横須賀共済病院(神奈川県)、横浜市立みなと赤十字病院(神奈川県)、青梅市立総合病院(東京都)、独立行政法人国立印刷局東京病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 07 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
2012 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 06 Day
Last modified on
2018 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011346

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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