UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II Clinical Trial to Test Efficacy and Safety of Autologous Peripheral Stem Cell Transplantation for Multiple Myeloma (C-SHOT 0401)
Title of the study (Brief title)	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	Isamu Sugiura
Organization	Toyohashi Municipal Hospital
Division name	Division of Hematology
Address	50 Hakken-Nishi, Aotake-cho, Toyohashi #441-8570
TEL	0532-33-6111
Email

Public contact
Name of contact person	Isamu Sugiura
Organization	Toyohashi Municipal Hospital
Division name	Division of Hematology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2004 Year 03 Month 26 Day
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

Related information
URL releasing protocol	http://www.c-shot.or.jp/
Publication of results	Unpublished
URL releasing results
Results
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