UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002533 |
|---|---|
| Receipt number | 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 21:10:18 |
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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
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
imaiyo-tky@umin.ac.jp
Sponsor or person
Institute
The university of Tokyo Hospital,department of hematology and oncology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003085
