UMIN-CTR Clinical Trial

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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