UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000178 |
|---|---|
| Receipt number | R000000248 |
| Scientific Title | Phase II Clinical Trial to Test Efficacy and Safety of Autologous Peripheral Stem Cell Transplantation for Multiple Myeloma (C-SHOT 0401) |
| Date of disclosure of the study information | 2005/09/12 |
| Last modified on | 2016/11/02 10:45:25 |
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Basic information
Public title
Phase II Clinical Trial to Test Efficacy and Safety of Autologous Peripheral Stem Cell Transplantation for Multiple Myeloma (C-SHOT 0401)
Acronym
Clinical Trial to Test Efficacy and Safety of Autologous Peripheral Stem Cell Transplantation for Multiple Myeloma (C-SHOT 0401)
Scientific Title
Phase II Clinical Trial to Test Efficacy and Safety of Autologous Peripheral Stem Cell Transplantation for Multiple Myeloma (C-SHOT 0401)
Scientific Title:Acronym
Clinical Trial to Test Efficacy and Safety of Autologous Peripheral Stem Cell Transplantation for Multiple Myeloma (C-SHOT 0401)
Region
| Japan |
Condition
Condition
multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test efficacy and safety of a series of treatment from induction chemotherapy to single peripheral autologous transplantation for patients with newly diagnosed multiple myeloma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate after 90 days from the 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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Therapy is composed of the following three steps of therapy.
1. induction chemotherapy(3 courses of C-VAD regimen)
2. peripheral stem cell collection after high dose cyclophosphamide
3. autologous peripheral stem cell transplantation after high dose melphalan
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Multiple Myeloma(SWOG criteria).
2. Durie&Salomon Stage II or III.
3. No previous treatments
4. age >=16 and <= 65
5. PS 0-2(ECOG)
6. No clinically significant abnormalities in liver, heart and pulmonary functions
7. Written informed consent
Key exclusion criteria
1. Severe renal dysfunction
2. Severe cardiovascular dysfunction
3. Active infections
4. Active opportunistic infections
5. Active double cancers
6. Subjects who, in the opinion of the investigator, are not likely to participate in the study for any reason
Target sample size
60
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 Hakken-Nishi, Aotake-cho, Toyohashi #441-8570
TEL
0532-33-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isamu Sugiura |
Organization
Toyohashi Municipal Hospital
Division name
Division of Hematology
Zip code
Address
50 Hakken-Nishi, Aotake-cho, Toyohashi #441-8570
TEL
0532-33-6111
Homepage URL
http://www.c-shot.or.jp/
isugiura-sgr@umin.ac.jp
Sponsor or person
Institute
Center for Supporting Hematology-Oncology Trials (C-SHOT)
Institute
Department
Personal name
Funding Source
Organization
Nagoya BMT group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Nagoya Muliple Myeloma Collaborated Group
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2005 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
http://www.c-shot.or.jp/
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
| 2004 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 12 | Day |
Last modified on
| 2016 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000248
