UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007188
Receipt No. 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

* 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
Email

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
Email

Sponsor
Institute University Of Tokyo Hospital,
Department of Hematology and Oncology
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008465

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.