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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002533
Receipt No. R000003085
Scientific Title autologous hematopoietic stem cell transplantation followed by reduced intensity allogeneic stem cell transplantation for relatively young patients with multiple myeloma
Date of disclosure of the study information 2009/11/01
Last modified on 2017/10/16

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Basic information
Public title autologous hematopoietic stem cell transplantation followed by reduced intensity allogeneic stem cell transplantation for relatively young patients with multiple myeloma
Acronym auto-allo HSCT for multiple myeloma
Scientific Title autologous hematopoietic stem cell transplantation followed by reduced intensity allogeneic stem cell transplantation for relatively young patients with multiple myeloma
Scientific Title:Acronym auto-allo HSCT for multiple myeloma
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 efficacy and safty of auto-HSCT followed by reduced intensity allotransplantation (cord blood or related donor)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes survival rate of patients at 100 days from allotransplantation
Key secondary outcomes overall survival, disease free survival and cummulative incidence of acute and chronic GVHD

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 auto-HSCT followed by reduced-intensity allotransplantation from related donor
Interventions/Control_2 auto-HSCT followed by reduced intensity allotransplantation using cord blood
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
15 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria 1.Meet all three criteria of IMWG
2.PS 0 to 2(including patients with PS 3 to 4 because of only bone pain)
3.1.VC greater than 0.8,FEV1 greater than 0.7,normal diffusing capacity,PaO2 greater than 80mmHg,PaCO2 less than 45mmHg,SaO2 greater than 0.96
3.2.no abnormal findings in echocardiography, EF greater than 0.55
3.3.Within two fold of normal value in T.Bil G-GTP ALP GOT GPT
3.4.CCr greater than 50ml per min
3.5.Without active infection
Key exclusion criteria 1.Patients who recall approval
2.When stem cell source becomes not available
3.Patients with another severe disease
4.Patients who had received chemotherapy for maligancies other than multipul myeloma
5.Patients who is recognized 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 The university of Tokyo Hospital
Division name Hematology and Oncology
Zip code
Address 7-3-1,Hongo,Bunkyo-ku,Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoichi Imai
Organization The university of Tokyo Hospital
Division name Hematology and Oncology
Zip code
Address
TEL
Homepage URL
Email imaiyo-tky@umin.ac.jp

Sponsor
Institute The university of Tokyo Hospital,department of hematology and oncology
Institute
Department

Funding Source
Organization The university of Tokyo Hospital,department of hematology and oncology
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
2009 Year 11 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 Completed
Date of protocol fixation
2008 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 19 Day
Last modified on
2017 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003085

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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