UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Maitenance therapy with bortezomib for multiple myeloma after autologus stem cell transplantation
Title of the study (Brief title)	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	Mineo Kurokawa
Organization	University of Tokyo Hospital
Division name	Hematology and Oncology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person	Motoshi Ichikawa
Organization	University of Tokyo Hospital
Division name	Hematology and Oncology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 12 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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