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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003076
Receipt No. R000003667
Scientific Title Phase II study to evaluate the safety and the efficacy of CBD (Bortezomib, Cyclophosphamide, Dexamethasone) regimen for the patients with relapsed and/or refractory multiple myeloma
Date of disclosure of the study information 2010/02/01
Last modified on 2012/02/14

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Basic information
Public title Phase II study to evaluate the safety and the efficacy of CBD (Bortezomib, Cyclophosphamide, Dexamethasone) regimen for the patients with relapsed and/or refractory multiple myeloma
Acronym Phase II study to evaluate the safety and the efficacy of CBD (Bortezomib, Cyclophosphamide, Dexamethasone) regimen for the patients with relapsed and/or refractory multiple myeloma
Scientific Title Phase II study to evaluate the safety and the efficacy of CBD (Bortezomib, Cyclophosphamide, Dexamethasone) regimen for the patients with relapsed and/or refractory multiple myeloma
Scientific Title:Acronym Phase II study to evaluate the safety and the efficacy of CBD (Bortezomib, Cyclophosphamide, Dexamethasone) regimen for the patients with relapsed and/or refractory multiple myeloma
Region
Japan

Condition
Condition relapsed and/or refractory multiple myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this trial is to evaluate the safety (mainly, neurotoxicity) and the efficacy of 4 cycles of CBD regimen for the patients with relapsed and/or refractory multiple myeloma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes safety (neurotoxixty evaluated by FACT/GOG NTX ver. 4.0)
Key secondary outcomes response rate as efficacy (antitumor activity) time to response, response rate after 5 more cycles, progression free survival, overall survival

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1.The case of having no neuropathy and neural pain due to peripheral neuropaty defined using NANDA
bortezomib(BTZ):1.3mg/m2 intravenously day 1,8,15 of 21-day cycle
cyclophosphamide(CY):50mg/body orally daily
dexamethasone(DEX):20mg/cody orally on day of and day after bortezomib

2.The case of having neuropathy and neural pain due to peripheral neuropaty defined using NANDA
bortezomib(BTZ):1.0mg/m2 intravenously day 1,8,15 of 21-day cycle
cyclophosphamide(CY):50mg/body orally daily
dexamethasone(DEX):20mg/cody orally on day of and day after bortezomib

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.performance status:0-2
2.total WBC count>=3000/mm3, absolute neutrophil count>=1000/mm3, platelete count>=75000/mm3, Hb>=8.0g/dL
3.ATL and AST of less than 2.5 times the ULN, TB. od less than 1.5 times the ULN
4.serum creatinine less than 1.5times the ULN
5.nomal ECG
6.no interstitial pneumonitis
7.peripheral and neuropaty grade<=2 defined using NCI-CTCAE v3.0
Key exclusion criteria performance status:3 and 4(excluding PS3 by bone pain and fracture)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideo Yagi
Organization Nara Hospital Kinki University School Of Medicine
Division name Department of Hematology
Zip code
Address 1248-1 Otsuda, Nara, 630-0293 JAPAN
TEL 0743-77-0880
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideo Yagi
Organization Nara Hospital Kinki University School Of Medicine
Division name Department of Hematology
Zip code
Address 1248-1 Otsuda, Nara, 630-0293 JAPAN
TEL 0743-77-0880
Homepage URL
Email

Sponsor
Institute Nara Hospital Kinki University School Of Medicine
Institute
Department

Funding Source
Organization Nara Hospital Kinki University School Of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 01 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 Open public recruiting
Date of protocol fixation
2009 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 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
2010 Year 01 Month 22 Day
Last modified on
2012 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003667

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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