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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011503
Receipt No. R000013401
Scientific Title Intermediate-cyclophosphamide and bortezomib for peripheral blood stem cell mobilization in multiple myeloma
Date of disclosure of the study information 2013/08/19
Last modified on 2013/08/16

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Basic information
Public title Intermediate-cyclophosphamide and bortezomib for peripheral blood stem cell mobilization in multiple myeloma
Acronym IDCY-BOR PBSCH Study
Scientific Title Intermediate-cyclophosphamide and bortezomib for peripheral blood stem cell mobilization in multiple myeloma
Scientific Title:Acronym IDCY-BOR PBSCH Study
Region
Japan

Condition
Condition multiple myeloma
Classification by specialty
Medicine in general Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of stem cell harvesting with intermediate-dose cyclophosphamide and bortezomib in multiple myeloma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Number of CD34 cells harvested
Safety
Key secondary outcomes CR and CR+VGPR
Incidence of graft failure

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 Cyclophosphamide 2g/m2/day day2,3 div
Bortezomib 1.3mg/m2/day day1,4.8.11 sc
G-CSF Filgrastim 400 microgram/m2/day or Lenograstim 10microgram/kg/day
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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1.Performance status(ECOG)0-2
2.Adequate organ function
Absolute neutrophil count; no less than 1000/mm3, platelet count; no less than 75000/mm3
AST/ALT; no less than 3 times the ULN, T-Bil; no less than 2.0mg/dl
Serum creatinine; no less than 2.0mg/dl
No severe cardiac failure
PaO2; more than 60mmHg or SaO2; more than 90%
3.Complete informed concent
Key exclusion criteria 1.Uncontrollable organ dysfunction(liver dysfuction, renal insufficiency, cardiac dysfunction, respiratory dysfunction, diabetes mellitus, infection)
2.Pregnant female
3.HBsAg positive, HCVAb positive, HIVAb positive
4.Coexistence of malignancy
5.Serious mental disorders
6.Those who are considered as inappropriate to register by attending physicians
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Yamaguchi
Organization Ishikawa Prefectural Central Hospital
Division name Department of Hematology
Zip code
Address 2-1 Kuratsuki Higashi, Kanazawa
TEL 076-237-8211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Aiko Sawazaki
Organization Ishikawa Prefectural Central Hospital
Division name Department of Hematology
Zip code
Address 2-1 Kuratsuki Higashi, Kanazawa
TEL 076-237-8211
Homepage URL
Email asawa2322@gmal.com

Sponsor
Institute Department of Hematology, Ishikawa Prefectural Central Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 08 Month 19 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
2013 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 10 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 08 Month 16 Day
Last modified on
2013 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013401

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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