UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003076 |
|---|---|
| Receipt number | 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 14:09:39 |
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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
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
Sponsor or person
Institute
Nara Hospital Kinki University School Of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003667
