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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000168
Receipt No. R000000239
Scientific Title Phase I study of non-myeloablative conditioning regimen of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors in patient with multiple myeloma that refractory or relapsed for autologous stem cell transplantation (C-SHOT0403)
Date of disclosure of the study information 2005/09/12
Last modified on 2007/06/25

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Basic information
Public title Phase I study of non-myeloablative conditioning regimen of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors in patient with multiple myeloma that refractory or relapsed for autologous stem cell transplantation (C-SHOT0403)
Acronym Phase I study of non-myeloablative conditioning regimen of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors in patient with multiple myeloma that refractory or relapsed for autologous stem cell transplantation (C-SHOT0403)
Scientific Title Phase I study of non-myeloablative conditioning regimen of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors in patient with multiple myeloma that refractory or relapsed for autologous stem cell transplantation (C-SHOT0403)
Scientific Title:Acronym Phase I study of non-myeloablative conditioning regimen of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors in patient with multiple myeloma that refractory or relapsed for autologous stem cell transplantation (C-SHOT0403)
Region
Japan

Condition
Condition Multiple myeloma that refractory or relapsed for autologous stem cell transplantation
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase I study to evaluate the safety of non-myeloablative conditioning regimen of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors in patient with multiple myeloma that refractory or relapsed for autologous stem cell transplantation.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes 1)Therapy related mortality at 100 days after hematopoietic stem cell transplantation 2)Engraftment rate at 100 days after hematopoietic stem cell transplantation
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Non-myeloablative conditioning of Fludarabine/melphalan for hematopoietic stemcell transplantation from HLA matched sibling donors
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 1) Refractory(except for CR and vPR) or relapse for autologus stem cell transplantation 2) Aged 20 to 65 years 3) HLA matched sibling donor 4) ECOG PS 0-2 5) Sufficient organ function 6) Written informed concent
Key exclusion criteria 1) Insulin dependent diabetes mellitus 2) Uncontrolable HT 3) Unstable angina, heart failure, or myocardial infarction 4) interstitial pneumonia or pulmonary fibrosis 5) positive HBs antigen 6) seropositive to HCV 7) seropositive to HIV 8) Severe infections 9)double cancer 10)Pregnant women 11) Sever mental disease 12) Patients inappropriate for transplantation with reasons other than above.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Morishima, M.D.,Ph.D.
Organization Aichi Cancer Center
Division name Department of Cell Therapy and Hematology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, JAPAN
TEL 052-762-6111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takakazu Kawase, M.D.
Organization Aichi Cancer Center
Division name Department of Cell Therapy and Hematology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, JAPAN
TEL 052-762-6111
Homepage URL http://www.c-shot.or.jp/study/0403/outline/
Email t-kawase@aidhi-cc.jp

Sponsor
Institute Nagoya BMT Group
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 C-SHOT0403
Org. issuing International ID_1 Center for Supporting Hematology-Oncology Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 12 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
2004 Year 08 Month 13 Day
Date of IRB
Anticipated trial start date
2004 Year 08 Month 01 Day
Last follow-up date
2008 Year 08 Month 01 Day
Date of closure to data entry
2008 Year 08 Month 01 Day
Date trial data considered complete
2008 Year 08 Month 01 Day
Date analysis concluded
2008 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 12 Day
Last modified on
2007 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000239

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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