UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	autologous hematopoietic stem cell transplantation followed by reduced intensity allogeneic stem cell transplantation for relatively young patients with multiple myeloma
Title of the study (Brief title)	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	Mineo Kurokawa
Organization	The university of Tokyo Hospital
Division name	Hematology and Oncology
Address	7-3-1,Hongo,Bunkyo-ku,Tokyo
TEL
Email

Public contact
Name of contact person	Yoichi Imai
Organization	The university of Tokyo Hospital
Division name	Hematology and Oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 11 Month 10 Day
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

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Publication of results	Unpublished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