UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005582 |
|---|---|
| Receipt number | R000006603 |
| Scientific Title | High-dose melphalan plus bortezomib for multiple myeloma patients as a conditioning of auto-PBSCT |
| Date of disclosure of the study information | 2011/05/10 |
| Last modified on | 2014/06/02 15:42:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
High-dose melphalan plus bortezomib for multiple myeloma patients as a conditioning of auto-PBSCT
Acronym
FBMTG-MM10
Scientific Title
High-dose melphalan plus bortezomib for multiple myeloma patients as a conditioning of auto-PBSCT
Scientific Title:Acronym
FBMTG-MM10
Region
| Japan |
Condition
Condition
multiple myeloma
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Blood transfusion |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of high-dose melphalan plus bortezomib for MM patients as a conditioning of auto-PBSCT.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
To investigate the efficacy and safety of high-dose melphalan plus bortezomib for MM patients as a conditioning of auto-PBSCT.
Key secondary outcomes
1) ORR at day 100
2) PFS at 1-yr
3) OS at 1-yr
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
high-dose melphalan plus bortezomib as a conditioning of auto-PBSCT
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)patients >SD
2)good PS
3)measurable disease
4)preserved organ function
Key exclusion criteria
1)nonsecreatry MM or PCL
2)patinets underwent HSCT previously
3)> grade2 PN
4)HIV,HBV,HCV
5)patients suffering from other active cancers
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Akashi |
Organization
Kyushu University Hospital
Division name
Hematology & Oncology
Zip code
Address
Fukuoka
TEL
092-642-5230
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyushu University Hospital
Division name
Hematology & Oncology
Zip code
Address
TEL
092-642-5230
Homepage URL
toshmiya@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
FBMTG
Institute
Department
Personal name
Funding Source
Organization
FBMTG
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
| 2011 | Year | 05 | Month | 10 | 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
| 2011 | Year | 04 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 10 | Day |
Last modified on
| 2014 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006603
