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


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 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


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

Value
https://center6.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