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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017713
Receipt No. R000018994
Scientific Title Phase II study of efficiency of peripheral blood stem cell harvest in multiple myeloma patients with low-dose cyclophosphamide plus G-CSF
Date of disclosure of the study information 2015/05/28
Last modified on 2015/05/28

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Basic information
Public title Phase II study of efficiency of peripheral blood stem cell harvest in multiple myeloma patients with low-dose cyclophosphamide plus G-CSF
Acronym Phase II study of efficiency of peripheral blood stem cell harvest in multiple myeloma patients with low-dose cyclophosphamide plus G-CSF
Scientific Title Phase II study of efficiency of peripheral blood stem cell harvest in multiple myeloma patients with low-dose cyclophosphamide plus G-CSF
Scientific Title:Acronym Phase II study of efficiency of peripheral blood stem cell harvest in multiple myeloma patients with low-dose cyclophosphamide plus G-CSF
Region
Japan

Condition
Condition multiple myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the efficacy and safety of low-dose cyclophosphamide plus G-GSF regimen for hematopoietic progenitor cell harvest
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Patients collecting >= 2*10^6 CD34+ cells/kg on day 1 (%)
Key secondary outcomes Safety
Incidence of adverse events (Grade 3)
Effect of this regimen on engraftment
The day of first apheresis

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 1)PBSC mobilization using low dose cyclophosphamide and G-CSF
2)autologous peripheral stem cell transplantation after high dose chemotherapy
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1)symptomatic multiple myeloma diagnosed by criteria of IMWG
2)The plasma cell in bone marrow counts <= 5%
3) Previous trearments with lenalidomide <= 4 courses
4) Patients who have the latest treatment more than 4 weeks before enrollment
5)age >=20 and <= 70
6)Performance Status(PS) of 0-2 on ECOG scale
7) Patients who have the following laboratory values within 14 days before enrollment
.neutrophil count >= 1000/mm3
. Hemoglobin>=8.0g/dl
. platelet count >= 100,000/mm3
. ALT <= 2.5 x upper limit of normal AST <= 2.5 x upper limit of normal
. serum total bilirubin <= 2.0mg/dl
. serum creatinine <= 2.0mg/dl
. Normal ECG or asymptomatic minor ECG change
. SpO2>=95%
8) Patients who are expected to survive more than 3 months
9) voluntary written informed consent
Key exclusion criteria 1) Patients with plasma cells in CBC
2) Pregnant or nursing women. Patients reuse to contraception during examination period
3) Patients have active other malignant diseases including simultaneous cancer and disease free state within 5 years after treatment for other cancer except curable intramural cancer by local treatment.
4) Patients with serious mental disorders
5) Patients with HBs antigen-positive
6) Patients with HIV antibody-positive
7) Patients with a history of severe allergy to the drugs
8) Patients with serious active infection
9) Patients who are considered as inappropriate to register by attending physicians
Target sample size 22

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chiaki Nakaseko
Organization Chiba University Hospital
Division name Department of Hematology
Zip code
Address 1-8-1 Inohana, Chuo-ku,Chiba city
TEL 043-222-7171
Email chiaki-nakaseko@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shio Sakai
Organization Chiba University Hospital
Division name Department of Transfusion Medicine and Cell Therapy
Zip code
Address 1-8-1 Inohana, Chuo-ku,Chiba city
TEL 043-222-7171
Homepage URL
Email shio-sakai@chiba-u.jp

Sponsor
Institute Department of Hematology
Chiba University Hospital
Institute
Department

Funding Source
Organization Department of Transfusion Medicine and Cell Therapy
Chiba University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2015 Year 05 Month 28 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 Open public recruiting
Date of protocol fixation
2015 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 28 Day
Last modified on
2015 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018994

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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