UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007188 |
|---|---|
| Receipt number | R000008465 |
| Scientific Title | Maitenance therapy with bortezomib for multiple myeloma after autologus stem cell transplantation |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2018/12/05 02:34:41 |
* 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
Maitenance therapy with bortezomib for multiple myeloma after autologus stem cell transplantation
Acronym
Maitenance therapy with bortezomib for multiple myeloma after autologus stem cell transplantation
Scientific Title
Maitenance therapy with bortezomib for multiple myeloma after autologus stem cell transplantation
Scientific Title:Acronym
Maitenance therapy with bortezomib for multiple myeloma after autologus stem cell transplantation
Region
| Japan |
Condition
Condition
multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safety of bortezomib as maintencence therapy for mutiple myeloma after autologous stemm cell transplanation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate 1 year after stem cell transplantation
Key secondary outcomes
Response rate 2 and 3 year after stem cell transplantation
Progression free survival, overall survival, and adverse events.
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
Bortezomib 1.3mg/m2 iv., day1, 8, 15, and 22. 6 courses in 35-day cycle.
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
1. Patients with multiple myeloma who have received autologous hematopoietic stem cell transplantation for the first time within 3 months.(Including patients who are planed to recieve autologous stem cell transplanation.)
2. Meet the guideline for administaration of Bortezmib at the start of the study treatment.
3. Clinical data at disease onset and before transplantation can be obtaioned.
4. Maintanance therapy can be started by 4 months after transplantation.
5. Written-informed consent has obtained.
Key exclusion criteria
1. Allergy for Bortezomib, mannitol, and boron.
2. A woman during pregnancy or potential pregnancy.
3. Patients who cannot stop drugs or therapy restricted in this trial.
4. Patients who are recoginized as inadaptable for this trial.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mineo Kurokawa |
Organization
University of Tokyo Hospital
Division name
Hematology and Oncology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoshi Ichikawa |
Organization
University of Tokyo Hospital
Division name
Hematology and Oncology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
University Of Tokyo Hospital,
Department of Hematology and Oncology
Institute
Department
Personal name
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
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
| 2012 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 12 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | 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
| 2012 | Year | 02 | Month | 01 | Day |
Last modified on
| 2018 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008465
