UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022421 |
|---|---|
| Receipt number | R000025841 |
| Scientific Title | A pilot study of peripheral blood stem cell harvest using bortezomib in combination with granulocyte colony stimulating factor (G-CSF) |
| Date of disclosure of the study information | 2016/05/25 |
| Last modified on | 2016/05/23 21:37:26 |
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Basic information
Public title
A pilot study of peripheral blood stem cell harvest using bortezomib in combination with granulocyte colony stimulating factor (G-CSF)
Acronym
Peripheral blood stem cell harvest with bortezomib and G-CSF
Scientific Title
A pilot study of peripheral blood stem cell harvest using bortezomib in combination with granulocyte colony stimulating factor (G-CSF)
Scientific Title:Acronym
Peripheral blood stem cell harvest with bortezomib and G-CSF
Region
| Japan |
Condition
Condition
Patients with multiple myeloma who are eligible for transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of peripheral blood stem cell harvest by using bortezomib and G-CSF
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Proportion of patients who are able to obtain more than 1.5 x10^6/kg of CD34-positive cells at one apheresis
Key secondary outcomes
Safety
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
G-CSF at a dose of 200 ug/m2 was given subcutaneously twice daily on day 1 to 5, and bortezomib at a dose of 1.3 mg/m2 was administered intravenously on day 4. Peripheral blood stem cells were collected by apheresis on day 5.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with multiple myeloma who are eligible for transplantation
Patients aged 20 years or older
Patients with normal organ function
Key exclusion criteria
Patients who are hypersensitive for either bortezomib or G-CSF
Patients with grade 2 or higher peripheral neuropathy
Patients with double cancer
Patients with psychological disorder
Patients with interstitial pneumonia
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Takamatsu |
Organization
Fukuoka University
Division name
Division of Medical Oncology, Hematology and Infectious Diseases, Department of Medicine
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL
092-801-1011
yasushi@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Takamatsu |
Organization
Fukuoka University
Division name
Division of Medical Oncology, Hematology and Infectious Diseases, Department of Medicine
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL
092-801-1011
Homepage URL
yasushi@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Division of Medical Oncology, Hematology and Infectious Diseases, Department of Medicin
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University
Division of Medical Oncology, Hematology and Infectious Diseases, Department of Medicin
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
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
福岡大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 25 | 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
| 2016 | Year | 05 | Month | 23 | Day |
Last modified on
| 2016 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025841
