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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001962
Receipt No. R000002394
Scientific Title Feasibility study of nonmyeloablative allogeneic stem cell transplantation as a consolidation after autologous peripheral blood stem cell transplantation for multiple myeloma with poor prognosis
Date of disclosure of the study information 2009/05/13
Last modified on 2011/12/20

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Basic information
Public title Feasibility study of nonmyeloablative allogeneic stem cell transplantation as a consolidation after autologous peripheral blood stem cell transplantation for multiple myeloma with poor prognosis
Acronym Nonmyeloablative allogeneic stem cell transplantation for multiple myeloma with poor prognosis
Scientific Title Feasibility study of nonmyeloablative allogeneic stem cell transplantation as a consolidation after autologous peripheral blood stem cell transplantation for multiple myeloma with poor prognosis
Scientific Title:Acronym Nonmyeloablative allogeneic stem cell transplantation for multiple myeloma with poor prognosis
Region
Japan

Condition
Condition Multiple myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to evaluate the feasibility of consolidation with nonmyeloablative allogeneic stem cell transplantation for multiple myeloma with poor prognosis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cumulative incidence of nonrelapse mortality at 6 months
Key secondary outcomes Engraftment rates, regimen-related toxicities, chimerism on peripheral blood, term to hematopoietic recovery, response rates, overall survival rates at 2 years, progression free survival at 2 years, nonrelapse mortality rates at 2 years, incidence of acute GVHD, and incidence of chronic GVHD

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
Maneuver
Interventions/Control_1 Nonmyeloablative allogeneic stem cell transplantation as a consolidation
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
65 years-old >=
Gender Male and Female
Key inclusion criteria All of the following are required.
(1)Multiple myeloma patient with evaluable lesion(s)
(2)Age between 20 and 65
(3)PS 0-2
(4)A patient should receive a single high-dose chemotherapy and autologous peripheral blood stem cell transplantation within 60-270 days and achieve partial or complete response.
(5)More than 1x106/kg cryopreserved autologous CD34 positive cells for backup
(6)A patient should have at least one unfavorable factor at initial treatment. Unfavorable factors include ISS stage 3, del13/complex CA/hypodiploid in G-band, t(4;14)/t(14;16)/del17p in FISH.
(7)Suitable donor is available: (a) HLA genotypically identical related donor or (b) HLA-ABC genotypically identical unrelated donor with HLA-DRB1 genotypically mismatched at 0-1 locus.
(8)(a) PaO2>70mmHg or SatO2>90% and (b) serum creatinine <1.5xWNL
(9)HCT-CI 0-2
(10)Written informed consent to participate in the trial.
Key exclusion criteria (1)Positive for HIV antibody, HBs antigen and/or HBe antigen
(2)Pregnant or during breast feeding
(3)Other active cancer
(4)Active psychiatric disease
(5)Active infection
(6)Allergic history to drugs used in the present conditioning regimen or GVHD prophylaxis regimen.
(7)Cases that physicians judged as inappropriate
Target sample size 22

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isamu Sugiura
Organization Toyohashi Municipal Hospital
Division name Division of Hematology
Zip code
Address 50 Aza Hachiken Nishi, Aotake&#8211;Cho, Toyohashi, Aichi, Japan
TEL 0532-33-6111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Inamoto
Organization Nagoya University Graduate School of Medicine
Division name Department of Hematology and Oncology
Zip code
Address 65 Tsurumai, Showa-ku, Nagoya, Aichi, Japan
TEL 052-744-2145
Homepage URL
Email yinamoto@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya Blood and Marrow Transplantation Group
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)

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 05 Month 13 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 Terminated
Date of protocol fixation
2009 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2014 Year 06 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 05 Month 12 Day
Last modified on
2011 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002394

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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