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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000178
Receipt No. 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

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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
Email

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/
Email isugiura-sgr@umin.ac.jp

Sponsor
Institute Center for Supporting Hematology-Oncology Trials (C-SHOT)
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000248

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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