UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000168 |
|---|---|
| Receipt number | 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 19:02:17 |
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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
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/
t-kawase@aidhi-cc.jp
Sponsor or person
Institute
Nagoya BMT Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000239
